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Council of the
European Union
Brussels, 25 November 2022
(OR. en)
14954/22
LIMITE
TELECOM 472
JAI 1494
COPEN 396
CYBER 374
DATAPROTECT 320
EJUSTICE 89
COSI 293
IXIM 267
ENFOPOL 569
RELEX 1556
MI 843
COMPET 918
CODEC 1773
Interinstitutional File:
2021/0106(COD)
NOTE
From: Permanent Representatives Committee (Part 1)
To: Council
No. prev. doc.: 14336/22
No. Cion doc.: 8115/21
Subject: Proposal for a Regulation of the European Parliament and of the Council 
laying down harmonised rules on artificial intelligence (Artificial Intelligence 
Act) and amending certain Union legislative acts
- General approach
I. INTRODUCTION
1. The Commission adopted the proposal for a Regulation laying down harmonised rules on 
artificial intelligence (Artificial Intelligence Act) on 21 April 2021.
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2. The objectives of the Commission proposal are to ensure that AI systems placed on the Union 
market and used in the Union are safe and respect existing law on fundamental rights and 
Union values, to ensure legal certainty in view of facilitating investment and innovation in AI, 
to enhance governance and effective enforcement of existing law on fundamental rights and 
safety, and to facilitate the development of a single market for lawful, safe and trustworthy AI 
applications, while preventing market fragmentation.
II. WORK IN THE OTHER INSTITUTIONS
3. In the European Parliament, the discussions are led by the Committee on Internal Market and 
Consumer Protection (IMCO; rapporteur: Brando Benifei, S&D, Italy) and the Committee on 
Civil Liberties, Justice and Home Affairs (LIBE; rapporteur: Dragos Tudorache, Renew, 
Romania) under a joint committee procedure. The Legal Affairs Committee (JURI), the 
Committee on Industry, Research and Energy (ITRE) and the Committee on Culture and 
Education (CULT) are associated to the legislative work with shared and/or exclusive 
competences. The two co-rapporteurs unveiled their draft report in April 2022, and the vote 
on the joint IMCO-LIBE report is scheduled for the first quarter of 2023.
4. The European Economic and Social Committee delivered its opinion on the proposal on 22 
September 2021, while the European Committee of the Regions followed with its opinion on 
2 December 2021.
5. On 18 June 2021 the European Data Protection Board (EDPB) and the European Data 
Protection Supervisor (EDPS) issued a joint opinion on the proposal.
6. The European Central Bank (ECB) issued its opinion on 29 December 2021 and presented it 
in the Working Party on Telecommunications and Information Society (hereinafter: WP 
TELECOM) on 10 February 2022.
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III. STATE OF PLAY IN THE COUNCIL 
1. In the Council, the examination of the proposal has been carried out in the WP TELECOM. 
The WP TELECOM started discussing the proposal under the Portuguese Presidency, with 
several meetings and workshops held between April and June 2021. The work on the proposal 
continued under the Slovenian Presidency, which drafted the first, partial compromise 
proposal covering Articles 1-7 and Annexes I-III. Additionally, the Slovenian Presidency 
organised a half a day informal Council of telecom ministers devoted exclusively to the AI 
Act proposal, during which the ministers confirmed their support for the horizontal and 
human-centric approach to regulating AI. The French Presidency continued the examination 
process and by the end of its term it redrafted the remaining parts of the text (Articles 8-85 
and Annexes IV-IX) and presented the entire first consolidated compromise proposal on the 
AI Act on 17 June 2022. 
2. On 5 July 2022, the Czech Presidency held a policy debate in WP TELECOM on the basis of 
a policy options paper, the outcomes of which were used to prepare the second compromise 
text. Based on the reactions of the delegations to this compromise, the Czech Presidency 
prepared the third compromise text, which was presented and discussed in WP TELECOM 
on 22 and 29 September 2022. After these discussions, the delegations were asked to provide 
further written comments, which were used by the Czech Presidency to draft the fourth 
compromise proposal. Based on the discussions of the fourth compromise proposal held in 
WP TELECOM on 25 October 2022 and 8 November 2022, as well as taking into account 
final written remarks from the Member States, the Czech Presidency has prepared the final 
version of the compromise text, which can be found in the Annex. On 18 November the 
Coreper examined this compromise proposal and unanimously agreed to submit it to the 
TTE (Telecommunications) Council, without any changes, in view of a general approach
at its meeting on 6 December 2022.
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IV. MAIN ELEMENTS OF THE COMPROMISE PROPOSAL 
1. Definition of an AI system, prohibited AI practices, list of high-risk AI use cases in 
Annex III, and classification of AI systems as high risk
1.1 In order to ensure that the definition of an AI system provides sufficiently clear criteria 
for distinguishing AI from more classical software systems, the compromise text narrows 
down the definition in Article 3(1) to systems developed through machine learning 
approaches and logic- and knowledge-based approaches.
1.2 As regards the delegation of powers to the Commission in relation to the updates of the 
definition of an AI system, Annex I and the corresponding empowerment for the Commission 
to update it by means of delegated acts has been deleted. Instead, new Recitals 6a and 6b
have been added to clarify what should be understood by machine learning approaches and 
logic- and knowledge-based approaches. To ensure that the AI Act remains flexible and future 
proof, a possibility to adopt implementing acts to further specify and update techniques under 
machine learning approaches and logic- and knowledge-based approaches has been added in 
Article 4. 
1.3 Concerning prohibited AI practices, in Article 5 the compromise text contains the 
extension of the prohibition of using AI for social scoring also to private actors. Furthermore, 
the provision prohibiting the use of AI systems that exploit the vulnerabilities of a specific 
group of persons now also covers persons who are vulnerable due to their social or economic 
situation. As regards the prohibition of the use of ‘real-time’ remote biometric identification 
systems in publicly accessible spaces by law enforcement authorities, the compromise text 
clarifies the objectives where such use is considered to be strictly necessary for law 
enforcement purposes and for which law enforcement authorities should therefore be 
exceptionally allowed to use such systems.
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1.4 As regards the list of high-risk AI use cases in Annex III, three of them have been 
deleted (deep fake detection by law enforcement authorities, crime analytics, verification of 
the authenticity of travel documents), two have been added (critical digital infrastructure and 
life and health insurance) and others have been fine-tuned. At the same time, Article 7(1) has 
been modified in order to provide for a possibility not only to add high-risk use cases to the 
list by means of delegated acts, but also delete them. In order to ensure that fundamental 
rights are adequately protected in case of such deletions, additional provisions have been 
added in Article 7(3), specifying the conditions which would need to be fulfilled before a 
delegated act can be adopted.
1.5 Regarding the classification of AI systems as high risk, the compromise proposal now 
includes an additional horizontal layer on top of the high-risk classification made in Annex 
III, in order to ensure that AI systems that are not likely to cause serious fundamental rights 
violations or other significant risks are not captured. More specifically, Article 6(3) contains 
new provisions according to which the significance of the output of the AI system in respect 
of the relevant action or a decision to be taken should also be taken into account when 
classifying AI systems as high risk. The significance of the output of an AI system would be 
assessed based on whether or not it is purely accessory in respect of the relevant action or 
decision to be taken.
2. Requirements for high-risk AI systems and responsibilities of various actors in the AI 
value chain
2.1 Many of the requirements for high-risk AI systems, as provided in Chapter 2 of Title 
III of the proposal, have been clarified and adjusted in such a way that they are more 
technically feasible and less burdensome for stakeholders to comply with, for example as 
regards the quality of data, or in relation to the technical documentation that should be drawn 
up by SMEs to demonstrate that their high-risk AI systems comply with the requirements.
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2.2 In view of the fact that AI systems are developed and distributed through complex value 
chains, the compromise text includes changes clarifying the allocation of responsibilities and 
roles. For example, some additional provisions in Articles 13 and 14 have been added that 
allow for more effective cooperation between providers and users. The compromise text also 
aims to clarify the relationship between the responsibilities under the AI Act and those that 
already exist under other legislation, such as the relevant Union data protection or sectorial 
legislation, including as regards the sector of financial services. Furthermore, the new Article 
23a indicates more clearly the situations in which other actors in the value chain are obliged 
to take on the responsibilities of a provider.
3. General purpose AI systems
3.1 A new Title IA has been added to account for situations where AI systems can be used 
for many different purposes (general purpose AI), and where there may be circumstances 
where general purpose AI technology gets integrated into another system which may become 
high-risk. The compromise text specifies in Article 4b(1) that certain requirements for highrisk AI systems would also apply to general purpose AI systems. However, instead of direct 
application of these requirements, an implementing act would specify how they should be 
applied in relation to general purpose AI systems, based on a consultation and detailed impact 
assessment and taking into account specific characteristics of these systems and related value 
chain, technical feasibility and market and technological developments. The use of an 
implementing act will ensure that the Member States will be properly involved and will keep 
the final say on how the requirements will be applied in this context.
3.2 Moreover, the compromise text of Article 4b(5) also includes a possibility to adopt 
further implementing acts which would lay down the modalities of cooperation between 
providers of general purpose AI systems and other providers intending to put into service or 
place such systems on the Union market as high-risk AI systems, in particular as regards the 
provision of information.
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4. Clarification of the scope of the proposed AI Act and provisions relating to law 
enforcement authorities
4.1 In Article 2 an explicit reference has been made to the exclusion of national security, 
defence and military purposes from the scope of the AI Act. Similarly, it has been clarified 
that the AI Act should not apply to AI systems and their outputs used for the sole purpose of 
research and development and to obligations of people using AI for non-professional 
purposes, which would fall outside the scope of the AI Act, except for the transparency 
obligations.
4.2 In order to take into account the particular specificities of law enforcement authorities, a 
number of changes has been made to provisions relating to the use of AI systems for law 
enforcement purposes. Notably, some of the related definitions in Article 3, such as ‘remote 
biometric identification system’ and ‘real-time remote biometric identification system’, have 
been fine-tuned in order to clarify what situations would fall under the related prohibition and 
high-risk use case and what situations would not. The compromise proposal also contains 
other modifications that are, subject to appropriate safeguards, meant to ensure appropriate 
level of flexibility in the use of high-risk AI systems by law enforcement authorities or reflect 
on the need to respect the confidentiality of sensitive operational data in relation to their 
activities.
5. Conformity assessments, governance framework, market surveillance, enforcement and 
penalties
5.1 In order to simplify the compliance framework for the AI Act, the compromise text 
contains a number of clarifications and simplifications to the provisions on the conformity 
assessment procedures. The provisions related to market surveillance have also been clarified 
and simplified in order to make them more effective and easier to implement, taking into 
account the need for a proportionate approach in this respect. Moreover, Article 41 has been 
thoroughly reviewed in order to limit the Commission’s discretion with regard to the adoption 
of implementing acts establishing common technical specifications for the requirements for 
high-risk AI systems and general purpose AI systems.
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5.2 The compromise text also substantially modifies the provisions concerning the AI 
Board ('the Board'), with the objectives to ensure its greater autonomy and to strengthen its 
role in the governance architecture for the AIA. In this context, Articles 56 and 58 have been 
revised in order to strengthen the role of the Board in such a way that it should be in a better 
position to provide support to the Member States in the implementation and enforcement of 
the AI Act. More specifically, the tasks of the Board have been extended and its composition 
has been specified. In order to ensure the involvement of the stakeholders in relation to all 
issues related to the implementation of the AI Act, including the preparation of implementing 
and delegates acts, a new requirement has been added for the Board to create a permanent 
subgroup serving as a platform for a wide range of stakeholders. Two other standing subgroups for market surveillance authorities and notifying authorities should also be established 
to reinforce the consistency of governance and enforcement of the AI Act across the Union.
5.3 To further improve the governance framework, the compromise text includes new 
Articles 68a and 68b. Article 68a includes a requirement for the Commission to designate 
one or more Union testing facilities in the area of artificial intelligence, which should provide 
independent technical or scientific advice at the request of the Board or market surveillance 
authorities, while Article 68b creates an obligation for the Commission to create a central 
pool of independent experts to support the enforcement activities required under the AI Act. 
Finally, there is also a new Article 58a laying down an obligation for the Commission to 
produce guidance on the application of the AI Act. 
5.4 As regards the penalties for infringements of the provisions of the AI Act, in Article 71 
the compromise text provides for more proportionate caps on the amount of administrative 
fines for SMEs and start-ups. Moreover, in Article 71(6) four more criteria have been added 
for deciding on the amount of administrative fines in order to further safeguard their overall 
proportionality. 
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6. Transparency and other provisions in favour of the affected persons
6.1 The compromise proposal includes a number of changes that increase the transparency 
with regard to the use of high-risk AI systems. Notably, Article 51 has been updated to 
indicate that certain users of high-risk of AI system that are public authorities, agencies or 
bodies will also be obliged to register in the EU database for high-risk AI systems listed in 
Annex III. Moreover, the newly added Article 52(2a) puts emphasis on an obligation for 
users of an emotion recognition system to inform natural persons when they are being 
exposed to such a system.
6.2 The compromise proposal also makes it clear in the newly added Article 63(11) that a 
natural or legal person who has reasons to consider that there has been an infringement of the 
provisions of the AI Act may make a complaint to the relevant market surveillance authority 
and may expect that such a complaint will be handled in line with the dedicated procedures of 
that authority.
7. Measures in support of innovation
7.1 With the objective to create a legal framework that is more innovation-friendly and in 
order to promote evidence-based regulatory learning, the provisions concerning measures in 
support of innovation in Article 53 have been substantially modified in the compromise text. 
Notably, it has been clarified that AI regulatory sandboxes, which are supposed to establish a 
controlled environment for the development, testing and validation of innovative AI systems 
under the direct supervision and guidance by the national competent authorities, should also 
allow for testing of innovative AI systems in real world conditions. Furthermore, new 
provisions in Articles 54a and 54b have been added allowing unsupervised real world testing 
of AI systems, under specific conditions and safeguards. In both cases the compromise text 
clarifies how these new rules are to be interpreted in relation to other existing, sectoral 
legislation on regulatory sandboxes. 
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7.2 Finally, in order to alleviate the administrative burden for smaller companies, in Article 
55 the compromise text includes a list of actions to be undertaken by the Commission to 
support such operators, and in Article 55a it provides for some limited and clearly specified 
derogations.
V. CONCLUSION 
1. In the light of the above, the Council is invited to: 
– examine the compromise text set out in the Annex to this note; 
– confirm a general approach on the proposal for a Regulation laying down harmonised 
rules on artificial intelligence (Artificial Intelligence Act) at the meeting of the TTE 
(Telecommunications) Council on 6 December 2022.
__________
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ANNEX
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE 
(ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION 
LEGISLATIVE ACTS
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 16 
and 114 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee1
,
Having regard to the opinion of the Committee of the Regions2
,
Having regard to the opinion of the European Central Bank3
,
Acting in accordance with the ordinary legislative procedure,
Whereas:
 
1 OJ C […], […], p. […].
2 OJ C […], […], p. […].
3 Reference to ECB opinion
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(1) The purpose of this Regulation is to improve the functioning of the internal market by laying 
down a uniform legal framework in particular for the development, marketing and use of 
artificial intelligence in conformity with Union values. This Regulation pursues a number of 
overriding reasons of public interest, such as a high level of protection of health, safety and 
fundamental rights, and it ensures the free movement of AI-based goods and services crossborder, thus preventing Member States from imposing restrictions on the development, 
marketing and use of AI systems, unless explicitly authorised by this Regulation.
(2) Artificial intelligence systems (AI systems) can be easily deployed in multiple sectors of the 
economy and society, including cross border, and circulate throughout the Union. Certain 
Member States have already explored the adoption of national rules to ensure that artificial 
intelligence is safe and is developed and used in compliance with fundamental rights 
obligations. Differing national rules may lead to fragmentation of the internal market and 
decrease legal certainty for operators that develop, import or use AI systems. A consistent 
and high level of protection throughout the Union should therefore be ensured, while 
divergences hampering the free circulation of AI systems and related products and services 
within the internal market should be prevented, by laying down uniform obligations for 
operators and guaranteeing the uniform protection of overriding reasons of public interest 
and of rights of persons throughout the internal market based on Article 114 of the Treaty on 
the Functioning of the European Union (TFEU). To the extent that this Regulation contains 
specific rules on the protection of individuals with regard to the processing of personal data 
concerning restrictions of the use of AI systems for ‘real-time’ remote biometric 
identification in publicly accessible spaces for the purpose of law enforcement, it is 
appropriate to base this Regulation, in as far as those specific rules are concerned, on Article 
16 of the TFEU. In light of those specific rules and the recourse to Article 16 TFEU, it is 
appropriate to consult the European Data Protection Board.
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(3) Artificial intelligence is a fast evolving family of technologies that can contribute to a wide 
array of economic and societal benefits across the entire spectrum of industries and social 
activities. By improving prediction, optimising operations and resource allocation, and 
personalising digital solutions available for individuals and organisations, the use of 
artificial intelligence can provide key competitive advantages to companies and support 
socially and environmentally beneficial outcomes, for example in healthcare, farming, 
education and training, infrastructure management, energy, transport and logistics, public 
services, security, justice, resource and energy efficiency, and climate change mitigation and 
adaptation.
(4) At the same time, depending on the circumstances regarding its specific application and use, 
artificial intelligence may generate risks and cause harm to public interests and rights that 
are protected by Union law. Such harm might be material or immaterial.
(5) A Union legal framework laying down harmonised rules on artificial intelligence is 
therefore needed to foster the development, use and uptake of artificial intelligence in the 
internal market that at the same time meets a high level of protection of public interests, 
such as health and safety and the protection of fundamental rights, as recognised and 
protected by Union law. To achieve that objective, rules regulating the placing on the market 
and putting into service of certain AI systems should be laid down, thus ensuring the smooth 
functioning of the internal market and allowing those systems to benefit from the principle 
of free movement of goods and services. By laying down those rules and building on the 
work of the High-level Expert Group on Artificial Intelligence as reflecetd in the Guidelines 
for Trustworthy Artificial Intelligence in the EU, this Regulation supports the objective of 
the Union of being a global leader in the development of secure, trustworthy and ethical 
artificial intelligence as stated by the European Council4
, and it ensures the protection of 
ethical principles, as specifically requested by the European Parliament5
.
 
4 European Council, Special meeting of the European Council (1 and 2 October 2020) – Conclusions, EUCO 
13/20, 2020, p. 6.
5 European Parliament resolution of 20 October 2020 with recommendations to the Commission on a framework 
of ethical aspects of artificial intelligence, robotics and related technologies, 2020/2012(INL).
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(5a) The harmonised rules on the placing on the market, putting into service and use of AI 
systems laid down in this Regulation should apply across sectors and, in line with its New 
Legislative Framework approach, should be without prejudice to existing Union law, 
notably on data protection, consumer protection, fundamental rights, employment and 
product safety, to which this Regulation is complementary. As a consequence all rights and 
remedies afforded by such Union law to consumers and other persons who may be 
negatively impacted by AI systems, including as regards the compensation of possible 
damages pursuant to Council Directive 85/374/EEC of 25 July 1985 on the approximation of 
the laws, regulations and administrative provisions of the Member States concerning 
liability for defective products, remain unaffected and fully applicable. On top of that, this 
Regulation aims to strengthen the effectiveness of such existing rights and remedies by 
establishing specific requirements and obligations, including in respect of transparency, 
technical documentation and record-keeping of AI systems. Furthermore, the obligations 
placed on various operators involved in the AI value chain under this Regulation should 
apply without prejudice to national laws, in compliance with Union law, having the effect 
of limiting the use of certain AI systems where such laws fall outside the scope of this 
Regulation or pursue other legitimate public interest objectives than those pursued by this 
Regulation. For example, national labour law and the laws on the protection of minors (i.e. 
persons below the age of 18) taking into account the United Nations General Comment No 
25 (2021) on children’s rights, insofar as they are not specific to AI systems and pursue 
other legimitate public interest objectives, should not be affected by this Regulation.
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(6) The notion of AI system should be clearly defined to ensure legal certainty, while providing 
the flexibility to accommodate future technological developments. The definition should be 
based on key functional characteristics of artificial intelligence such as its learning, 
reasoning or modelling capabilities, distinguishing it from simpler software systems and 
programming approaches. In particular, for the purposes of this Regulation AI systems 
should have the ability, on the basis of machine and/or human-based data and inputs, to infer 
the way to achieve a set of final objectives given to them by humans, using machine learning 
and/or logic- and knowledge based approaches and to produce outputs such as content for 
generative AI systems (e.g. text, video or images), predictions, recommendations or 
decisions, influencing the environment with which the system interacts, be it in a physical or 
digital dimension. A system that uses rules defined solely by natural persons to 
automatically execute operations should not be considered an AI system. AI systems can be 
designed to operate with varying levels of autonomy and be used on a stand-alone basis or 
as a component of a product, irrespective of whether the system is physically integrated into 
the product (embedded) or serve the functionality of the product without being integrated 
therein (non-embedded). The concept of the autonomy of an AI system relates to the degree 
to which such a system functions without human involvement.
(6a) Machine learning approaches focus on the development of systems capable of learning and 
inferring from data to solve an application problem without being explicitly programmed
with a set of step-by-step instructions from input to output. Learning refers to the 
computational process of optimizing from data the parameters of the model, which is a 
mathematical construct generating an output based on input data. The range of problems 
addressed by machine learning typically involves tasks for which other approaches fail, 
either because there is no suitable formalisation of the problem, or because the resolution of 
the problem is intractable with non-learning approaches. Machine learning approaches 
include for instance supervised, unsupervised and reinforcement learning, using a variety of 
methods including deep learning with neural networks, statistical techniques for learning 
and inference (including for instance logistic regression, Bayesian estimation) and search 
and optimisation methods.
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(6b) Logic- and knowledge based approaches focus on the development of systems with logical 
reasoning capabilities on knowledge to solve an application problem. Such systems typically 
involve a knowledge base and an inference engine that generates outputs by reasoning on 
the knowledge base. The knowledge base, which is usually encoded by human experts, 
represents entities and logical relationships relevant for the application problem through 
formalisms based on rules, ontologies, or knowledge graphs. The inference engine acts on 
the knowledge base and extracts new information through operations such as sorting,
searching, matching or chaining. Logic- and knowledge based approaches include for 
instance knowledge representation, inductive (logic) programming, knowledge bases, 
inference and deductive engines, (symbolic) reasoning, expert systems and search and 
optimisation methods.
(6c) In order to ensure uniform conditions for the implementation of this Regulation as regards 
machine learning approaches and logic- and knowledged based approaches and to take 
account of market and technological developments, implementing powers should be 
conferred on the Commission.
(6d) The notion of ‘user’ referred to in this Regulation should be interpreted as any natural or 
legal person, including a public authority, agency or other body, using an AI system under 
whose authority the system is used. Depending on the type of AI system, the use of the 
system may affect persons other than the user. 
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(7) The notion of biometric data used in this Regulation should be interpreted consistently with 
the notion of biometric data as defined in Article 4(14) of Regulation (EU) 2016/679 of the 
European Parliament and of the Council6
, Article 3(18) of Regulation (EU) 2018/1725 of the 
European Parliament and of the Council7
and Article 3(13) of Directive (EU) 2016/680 of 
the European Parliament and of the Council8
. 
 
6 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection 
of natural persons with regard to the processing of personal data and on the free movement of such data, and 
repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
7 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the 
protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, 
offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and 
Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39)
8 Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of 
natural persons with regard to the processing of personal data by competent authorities for the purposes of the 
prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, 
and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (Law 
Enforcement Directive) (OJ L 119, 4.5.2016, p. 89).
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(8) The notion of remote biometric identification system as used in this Regulation should be 
defined functionally, as an AI system intended for the identification of natural persons 
typically at a distance, without their active involvement, through the comparison of a 
person’s biometric data with the biometric data contained in a reference data repository, 
irrespectively of the particular technology, processes or types of biometric data used. Such 
remote biometric identification systems are typically used to perceive (scan) multiple 
persons or their behaviour simultaneously in order to facilitate significantly the 
identification of a number of persons without their active involvement. Such a definition 
excludes verification/authentication systems whose sole purpose would be to confirm that a 
specific natural person is the person he or she claims to be, as well as systems that are used 
to confirm the identity of a natural person for the sole purpose of having access to a service, 
a device or premises. This exclusion is justified by the fact that such systems are likely to 
have a minor impact on fundamental rights of natural persons compared to remote biometric 
identification systems which may be used for the processing of the biometric data of a large 
number of persons. In the case of ‘real-time’ systems, the capturing of the biometric data, 
the comparison and the identification occur all instantaneously, near-instantaneously or in 
any event without a significant delay. In this regard, there should be no scope for 
circumventing the rules of this Regulation on the ‘real-time’ use of the AI systems in 
question by providing for minor delays. ‘Real-time’ systems involve the use of ‘live’ or 
‘near-‘live’ material, such as video footage, generated by a camera or other device with 
similar functionality. In the case of ‘post’ systems, in contrast, the biometric data have 
already been captured and the comparison and identification occur only after a significant 
delay. This involves material, such as pictures or video footage generated by closed circuit 
television cameras or private devices, which has been generated before the use of the system 
in respect of the natural persons concerned.
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(9) For the purposes of this Regulation the notion of publicly accessible space should be 
understood as referring to any physical place that is accessible to an undetermined number 
of natural persons, and irrespective of whether the place in question is privately or publicly 
owned. and irrepective of the activity for which the place may be used, such as commerce 
(for instance, shops, restaurants, cafés), services (for instance, banks, professional activities, 
hospitality), sport (for instance, swimming pools, gyms, stadiums), transport (for instance, 
bus, metro and railway stations, airports, means of transport ), entertainment (for instance, 
cinemas, theatres, museums, concert and conference halls) leisure or otherwise (for instance, 
public roads and squares, parks, forests, playgrounds). A place should be classified as 
publicly accessible also if, regardless of potential capacity or security restrictions, access is 
subject to certain predetermined conditions, which can be fulfilled by an undetermined 
number of persons, such as purchase of a ticket or title of transport, prior registration or 
having a certain age. By contrast, a place should not be considered publicly accessible if 
access is limited to specific and defined natural persons through either Union or national law 
directly related to public safety or security or through the clear manifestation of will by the 
person having the relevant authority on the place. The factual possibility of access alone 
(e.g. an unlocked door, an open gate in a fence) does not imply that the place is publicly 
accessible in the presence of indications or circumstances suggesting the contrary (e.g. signs 
prohibiting or restricting access). Company and factory premises as well as offices and 
workplaces that are intended to be accessed only by relevant employees and service 
providers are places that are not publicly accessible. Publicly accessible spaces should not 
include prisons or border control areas. Some other areas may be composed of both not 
publicly accessible and publicly accessible areas, such as the hallway of a private residential 
building necessary to access a doctor's office or an airport. Online spaces are not covered 
either, as they are not physical spaces. Whether a given space is accessible to the public 
should however be determined on a case-by-case basis, having regard to the specificities of 
the individual situation at hand.
(10) In order to ensure a level playing field and an effective protection of rights and freedoms of 
individuals across the Union, the rules established by this Regulation should apply to 
providers of AI systems in a non-discriminatory manner, irrespective of whether they are 
established within the Union or in a third country, and to users of AI systems established 
within the Union.
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(11) In light of their digital nature, certain AI systems should fall within the scope of this 
Regulation even when they are neither placed on the market, nor put into service, nor used 
in the Union. This is the case for example of an operator established in the Union that 
contracts certain services to an operator established outside the Union in relation to an 
activity to be performed by an AI system that would qualify as high-risk. In those 
circumstances, the AI system used by the operator outside the Union could process data 
lawfully collected in and transferred from the Union, and provide to the contracting operator 
in the Union the output of that AI system resulting from that processing, without that AI 
system being placed on the market, put into service or used in the Union. To prevent the 
circumvention of this Regulation and to ensure an effective protection of natural persons 
located in the Union, this Regulation should also apply to providers and users of AI systems 
that are established in a third country, to the extent the output produced by those systems is 
used in the Union. Nonetheless, to take into account existing arrangements and special needs 
for future cooperation with foreign partners with whom information and evidence is 
exchanged, this Regulation should not apply to public authorities of a third country and 
international organisations when acting in the framework of international agreements 
concluded at national or European level for law enforcement and judicial cooperation with 
the Union or with its Member States. Such agreements have been concluded bilaterally 
between Member States and third countries or between the European Union, Europol and 
other EU agencies and third countries and international organisations. Recipient Member 
States authorities and Union institutions, offices, bodies and bodies making use of such 
outputs in the Union remain accountable to ensure their use comply with Union law. When 
those international agreements are revised or new ones are concluded in the future, the 
contracting parties should undertake the utmost effort to align those agreements with the 
requirements of this Regulation.
(12) This Regulation should also apply to Union institutions, offices, bodies and agencies when 
acting as a provider or user of an AI system. 
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(-12a) If and insofar AI systems are placed on the market, put into service, or used with or without 
modification of such systems for military, defence or national security purposes, those 
should be excluded from the scope of this Regulation regardless of which type of entity is 
carrying out those activities, such as whether it is a public or private entity. As regards 
military and defence purposes, such exclusion is justified both by Article 4(2) TEU and by 
the specifities of the Member States’ and the common Union defence policy covered by 
Chapter 2 of Title V of the Treaty on European Union (TEU) that are subject to public 
international law, which is therefore the more appropriate legal framework for the regulation 
of AI systems in the context of the use of lethal force and other AI systems in the context of 
military and defence activities. As regards national security purposes, the exclusion is 
justified both by the fact that national security remains the sole responsibility of Member 
States in accordance with Article 4(2) TEU and by the specific nature and operational needs 
of national security activities and specific national rules applicable to those activities. 
Nonetheless, if an AI system developed, placed on the market, put into service or used for 
military, defence or national security purposes is used outside those temporarily or 
permanently for other purposes (for example, civilian or humanitarian purposes, law 
enforcement or public security purposes), such a system would fall within the scope of this 
Regulation. In that case, the entity using the system for other than military, defence or 
national security purposes should ensure compliance of the system with this Regulation, 
unless the system is already compliant with this Regulation. AI systems placed on the 
market or put into service for an excluded (i.e. military, defence or national security) and 
one or more non excluded purposes (e.g. civilian purposes, law enforcement, etc.), fall 
within the scope of this Regulation and providers of those systems should ensure compliance 
with this Regulation. In those cases, the fact that an AI system may fall within the scope of 
this Regulation should not affect the possibility of entities carrying out national security, 
defence and military activities, regardless of the type of entity carrying out those activities, 
to use AI systems for national security, military and defence purposes, the use of which is 
excluded from the scope of this Regulation. An AI system placed on the market for civilian 
or law enforcement purposes which is used with or without modification for military, 
defence or national security purposes should not fall within the scope of this Regulation,
regardless of the type of entity carrying out those activities. 
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(12a) This Regulation should be without prejudice to the provisions regarding the liability of 
intermediary service providers set out in Directive 2000/31/EC of the European Parliament 
and of the Council [as amended by the Digital Services Act].
(12b) This Regulation should not undermine research and development activity and should respect 
freedom of science. It is therefore necessary to exclude from its scope AI systems 
specifically developed and put into service for the sole purpose of scientific research and 
development and to ensure that the Regulation does not otherwise affect scientific research 
and development activity on AI systems. As regards product oriented research activity by 
providers, the provisions of this Regulation should also not apply. This is without prejudice 
to the obligation to comply with this Regulation when an AI system falling into the scope of 
this Regulation is placed on the market or put into service as a result of such research and 
development activity and to the application of provisions on regulatory sandboxes and 
testing in real world conditions. Furthermore, without prejudice to the foregoing regarding 
AI systems specifically developed and put into service for the sole purpose of scientific 
research and development, any other AI system that may be used for the conduct of any 
reaserch and development activity should remain subject to the provisions of this 
Regulation. Under all circumstances, any research and development activity should be 
carried out in accordance with recognised ethical and professional standards for scientific 
research.
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(12c) In the light of the nature and complexity of the value chain for AI systems, it is essential to 
clarify the role of actors who may contribute to the development of AI systems, notably 
high-risk AI systems. In particular, it is necessary to clarify that general purpose AI systems 
are AI systems that are intended by the provider to perform generally applicable functions, 
such as image/speech recognition, and in a plurality of contexts. They may be used as highrisk AI systems by themselves or be components of other high risk AI systems. Therefore, 
due to their particular nature and in order to ensure a fair sharing of responsibilities along 
the AI value chain, such systems should be subject to proportionate and more specific
requirements and obligations under this Regulation while ensuring a high level of protection 
of fundamental rights, health and safety. In addition, the providers of general purpose AI 
systems, irrespective of whether they may be used as high-risk AI systems as such by other 
providers or as components of high-risk AI systems, should cooperate, as appropriate, with 
the providers of the respective high-risk AI systems to enable their compliance with the 
relevant obligations under this Regulation and with the competent authorities established 
under this Regulation. In order to take into account the specific characteristics of general 
purpose AI systems and the fast evolving market and technological developments in the 
field, implementing powers should be conferred on the Commission to specify and adapt the 
application of the requirements established under this Regulation to general purpose AI 
systems and to specify the information to be shared by the providers of general purpose AI 
systems in order to enable the providers of the respective high-risk AI system to comply 
with their obligations under this Regulation.
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(13) In order to ensure a consistent and high level of protection of public interests as regards 
health, safety and fundamental rights, common normative standards for all high-risk AI 
systems should be established. Those standards should be consistent with the Charter of 
fundamental rights of the European Union (the Charter) and should be non-discriminatory 
and in line with the Union’s international trade commitments.
(14) In order to introduce a proportionate and effective set of binding rules for AI systems, a 
clearly defined risk-based approach should be followed. That approach should tailor the type 
and content of such rules to the intensity and scope of the risks that AI systems can generate. 
It is therefore necessary to prohibit certain artificial intelligence practices, to lay down 
requirements for high-risk AI systems and obligations for the relevant operators, and to lay 
down transparency obligations for certain AI systems.
(15) Aside from the many beneficial uses of artificial intelligence, that technology can also be 
misused and provide novel and powerful tools for manipulative, exploitative and social 
control practices. Such practices are particularly harmful and should be prohibited because 
they contradict Union values of respect for human dignity, freedom, equality, democracy 
and the rule of law and Union fundamental rights, including the right to non-discrimination, 
data protection and privacy and the rights of the child.
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(16) AI-enabled manipulative techniques can be used to persuade persons to engage in unwanted 
behaviours, or to deceive them by nudging them into decisions in a way that subverts and 
impairs their autonomy, decision-making and free choices. The placing on the market, 
putting into service or use of certain AI systems materially distorting human behaviour, 
whereby physical or psychological harms are likely to occur, are particularly dangerous and 
should therefore be forbidden. Such AI systems deploy subliminal components such as 
audio, image, video stimuli that persons cannot perceive as those stimuli are beyond human 
perception or other subliminal techniques that subvert or impair person’s autonomy, 
decision-making or free choices in ways that people are not consciously aware of, or even if 
aware not able to control or resist, for example in cases of machine-brain interfaces or 
virtual reality. In addition, AI systems may also otherwise exploit vulnerabilities of a 
specific group of persons due to their age, disability within the meaning of Directive (EU) 
2019/882, or a specific social or economic situation that is likely to make those persons 
more vulnerable to exploitation such as persons living in extreme poverty, ethnic or 
religious minorities. Such AI systems can be placed on the market, put into service or used 
with the objective to or the effect of materially distorting the behaviour of a person and in a 
manner that causes or is reasonably likely to cause physical or phycological harm to that or 
another person or groups of persons, including harms that may be accumulated over time. 
The intention to distort the behaviour may not be presumed if the distortion results from 
factors external to the AI system which are outside of the control of the provider or the user, 
meaning factors that may not be reasonably foreseen and mitigated by the provider or the 
user of the AI system. In any case, it is not necessary for the provider or the user to have the 
intention to cause the physical or psychological harm, as long as such harm results from the 
manipulative or exploitative AI-enabled practices. The prohibitions for such AI practices are 
complementary to the provisions contained in Directive 2005/29/EC, notably that unfair 
commercial practices leading to economic or financial harms to consumers are prohibited 
under all circumstances, irrespective of whether they are put in place through AI systems or 
otherwise. The prohibitions of manipulative and exploitative practices in this Regulation 
should not affect lawful practices in the context of medical treatment such as psychological 
treatment of a mental disease or physical rehabilitation, when those practices are carried out 
in accordance with the applicable medical standards and legislation. In addition, common 
and legitimate commercial practices that are in compliance with the applicable law should 
not in themselves be regarded as constituting harmful manipulative AI practices.
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(17) AI systems providing social scoring of natural persons by public authorities or by private 
actors may lead to discriminatory outcomes and the exclusion of certain groups. They may 
violate the right to dignity and non-discrimination and the values of equality and justice. 
Such AI systems evaluate or classify natural persons based on their social behaviour in 
multiple contexts or known or predicted personal or personality characteristics. The social 
score obtained from such AI systems may lead to the detrimental or unfavourable treatment 
of natural persons or whole groups thereof in social contexts, which are unrelated to the 
context in which the data was originally generated or collected or to a detrimental treatment 
that is disproportionate or unjustified to the gravity of their social behaviour. AI systems 
entailing such unacceptable scoring practices should be therefore prohibited. This 
prohibition should not affect lawful evaluation practices of natural persons done for one or 
more specific purpose in compliance with the law.
(18) The use of AI systems for ‘real-time’ remote biometric identification of natural persons in 
publicly accessible spaces for the purpose of law enforcement is considered particularly 
intrusive in the rights and freedoms of the concerned persons, to the extent that it may affect 
the private life of a large part of the population, evoke a feeling of constant surveillance and 
indirectly dissuade the exercise of the freedom of assembly and other fundamental rights. In 
addition, the immediacy of the impact and the limited opportunities for further checks or 
corrections in relation to the use of such systems operating in ‘real-time’ carry heightened 
risks for the rights and freedoms of the persons that are concerned by law enforcement 
activities.
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(19) The use of those systems for the purpose of law enforcement should therefore be prohibited, 
except in exhaustively listed and narrowly defined situations, where the use is strictly 
necessary to achieve a substantial public interest, the importance of which outweighs the 
risks. Those situations involve the search for potential victims of crime, including missing 
children; certain threats to the life or physical safety of natural persons or of a terrorist 
attack; and the detection, localisation, identification or prosecution of perpetrators or 
suspects of the criminal offences referred to in Council Framework Decision 2002/584/JHA9
if those criminal offences are punishable in the Member State concerned by a custodial 
sentence or a detention order for a maximum period of at least three years and as they are 
defined in the law of that Member State. Such threshold for the custodial sentence or 
detention order in accordance with national law contributes to ensure that the offence should 
be serious enough to potentially justify the use of ‘real-time’ remote biometric identification 
systems. Moreover, of the 32 criminal offences listed in the Council Framework Decision 
2002/584/JHA, some are in practice likely to be more relevant than others, in that the 
recourse to ‘real-time’ remote biometric identification will foreseeably be necessary and 
proportionate to highly varying degrees for the practical pursuit of the detection, 
localisation, identification or prosecution of a perpetrator or suspect of the different criminal 
offences listed and having regard to the likely differences in the seriousness, probability and 
scale of the harm or possible negative consequences. In addition, this Regulation should 
preserve the ability for law enforcement, border control, immigration or asylum authorities 
to carry out identity checks in the presence of the person that is concerned in accordance 
with the conditions set out in Union and national law for such checks. In particular, law 
enforcement, border control, immigration or asylum authorities should be able to use 
information systems, in accordance with Union or national law, to identify a person who, 
during an identity check, either refuses to be identified or is unable to state or prove his or 
her identity, without being required by this Regulation to obtain prior authorisation. This 
could be, for example, a person involved in a crime, being unwilling, or unable due to an 
accident or a medical condition, to disclose their identity to law enforcement authorities.
 
9 Council Framework Decision 2002/584/JHA of 13 June 2002 on the European arrest warrant and the surrender 
procedures between Member States (OJ L 190, 18.7.2002, p. 1).
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(20) In order to ensure that those systems are used in a responsible and proportionate manner, it 
is also important to establish that, in each of those exhaustively listed and narrowly defined 
situations, certain elements should be taken into account, in particular as regards the nature 
of the situation giving rise to the request and the consequences of the use for the rights and 
freedoms of all persons concerned and the safeguards and conditions provided for with the 
use. In addition, the use of ‘real-time’ remote biometric identification systems in publicly 
accessible spaces for the purpose of law enforcement should be subject to appropriate limits 
in time and space, having regard in particular to the evidence or indications regarding the 
threats, the victims or perpetrator. The reference database of persons should be appropriate 
for each use case in each of the situations mentioned above.
(21) Each use of a ‘real-time’ remote biometric identification system in publicly accessible 
spaces for the purpose of law enforcement should be subject to an express and specific 
authorisation by a judicial authority or by an independent administrative authority of a 
Member State. Such authorisation should in principle be obtained prior to the use of the 
system with a view to identify a person or persons. Exceptions to this rule should be allowed 
in duly justified situations of urgency, that is, situations where the need to use the systems in 
question is such as to make it effectively and objectively impossible to obtain an 
authorisation before commencing the use. In such situations of urgency, the use should be 
restricted to the absolute minimum necessary and be subject to appropriate safeguards and 
conditions, as determined in national law and specified in the context of each individual 
urgent use case by the law enforcement authority itself. In addition, the law enforcement 
authority should in such situations seek to obtain an authorisation as soon as possible, whilst 
providing the reasons for not having been able to request it earlier. 
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(22) Furthermore, it is appropriate to provide, within the exhaustive framework set by this 
Regulation that such use in the territory of a Member State in accordance with this 
Regulation should only be possible where and in as far as the Member State in question has 
decided to expressly provide for the possibility to authorise such use in its detailed rules of 
national law. Consequently, Member States remain free under this Regulation not to provide 
for such a possibility at all or to only provide for such a possibility in respect of some of the 
objectives capable of justifying authorised use identified in this Regulation.
(23) The use of AI systems for ‘real-time’ remote biometric identification of natural persons in 
publicly accessible spaces for the purpose of law enforcement necessarily involves the 
processing of biometric data. The rules of this Regulation that prohibit, subject to certain 
exceptions, such use, which are based on Article 16 TFEU, should apply as lex specialis in 
respect of the rules on the processing of biometric data contained in Article 10 of Directive 
(EU) 2016/680, thus regulating such use and the processing of biometric data involved in an 
exhaustive manner. Therefore, such use and processing should only be possible in as far as it 
is compatible with the framework set by this Regulation, without there being scope, outside 
that framework, for the competent authorities, where they act for purpose of law 
enforcement, to use such systems and process such data in connection thereto on the grounds 
listed in Article 10 of Directive (EU) 2016/680. In this context, this Regulation is not 
intended to provide the legal basis for the processing of personal data under Article 8 of 
Directive 2016/680. However, the use of ‘real-time’ remote biometric identification systems 
in publicly accessible spaces for purposes other than law enforcement, including by 
competent authorities, should not be covered by the specific framework regarding such use 
for the purpose of law enforcement set by this Regulation. Such use for purposes other than 
law enforcement should therefore not be subject to the requirement of an authorisation under 
this Regulation and the applicable detailed rules of national law that may give effect to it.
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(24) Any processing of biometric data and other personal data involved in the use of AI systems 
for biometric identification, other than in connection to the use of ‘real-time’ remote 
biometric identification systems in publicly accessible spaces for the purpose of law 
enforcement as regulated by this Regulation, should continue to comply with all 
requirements resulting from Article 10 of Directive (EU) 2016/680. For purposes other than 
law enforcement, Article 9(1) of Regulation (EU) 2016/679 and Article 10(1) of Regulation 
(EU) 2018/1725 prohibit the processing of biometric data for the purpose of uniquely 
identifying a natural person, unless one of the situations in the respective second paragraphs 
of those two articles applies.
(25) In accordance with Article 6a of Protocol No 21 on the position of the United Kingdom and 
Ireland in respect of the area of freedom, security and justice, as annexed to the TEU and to 
the TFEU, Ireland is not bound by the rules laid down in Article 5(1), point (d), (2), (3) and 
(4) of this Regulation adopted on the basis of Article 16 of the TFEU which relate to the 
processing of personal data by the Member States when carrying out activities falling within 
the scope of Chapter 4 or Chapter 5 of Title V of Part Three of the TFEU, where Ireland is 
not bound by the rules governing the forms of judicial cooperation in criminal matters or 
police cooperation which require compliance with the provisions laid down on the basis of 
Article 16 of the TFEU. 
(26) In accordance with Articles 2 and 2a of Protocol No 22 on the position of Denmark, annexed 
to the TEU and TFEU, Denmark is not bound by rules laid down in Article 5(1), point (d), 
(2), (3) and (4) of this Regulation adopted on the basis of Article 16 of the TFEU, or subject 
to their application, which relate to the processing of personal data by the Member States 
when carrying out activities falling within the scope of Chapter 4 or Chapter 5 of Title V of 
Part Three of the TFEU.
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(27) High-risk AI systems should only be placed on the Union market or put into service if they 
comply with certain mandatory requirements. Those requirements should ensure that highrisk AI systems available in the Union or whose output is otherwise used in the Union do not 
pose unacceptable risks to important Union public interests as recognised and protected by 
Union law. AI systems identified as high-risk should be limited to those that have a 
significant harmful impact on the health, safety and fundamental rights of persons in the 
Union and such limitation minimises any potential restriction to international trade, if any.
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(28) AI systems could produce adverse outcomes to health and safety of persons, in particular 
when such systems operate as components of products. Consistently with the objectives of 
Union harmonisation legislation to facilitate the free movement of products in the internal 
market and to ensure that only safe and otherwise compliant products find their way into the 
market, it is important that the safety risks that may be generated by a product as a whole 
due to its digital components, including AI systems, are duly prevented and mitigated. For 
instance, increasingly autonomous robots, whether in the context of manufacturing or 
personal assistance and care should be able to safely operate and performs their functions in 
complex environments. Similarly, in the health sector where the stakes for life and health are 
particularly high, increasingly sophisticated diagnostics systems and systems supporting 
human decisions should be reliable and accurate. The extent of the adverse impact caused by 
the AI system on the fundamental rights protected by the Charter is of particular relevance 
when classifying an AI system as high-risk. Those rights include the right to human dignity, 
respect for private and family life, protection of personal data, freedom of expression and 
information, freedom of assembly and of association, and non-discrimination, consumer 
protection, workers’ rights, rights of persons with disabilities, right to an effective remedy 
and to a fair trial, right of defence and the presumption of innocence, right to good 
administration. In addition to those rights, it is important to highlight that children have 
specific rights as enshrined in Article 24 of the EU Charter and in the United Nations 
Convention on the Rights of the Child (further elaborated in the UNCRC General Comment 
No. 25 as regards the digital environment), both of which require consideration of the 
children’s vulnerabilities and provision of such protection and care as necessary for their 
well-being. The fundamental right to a high level of environmental protection enshrined in 
the Charter and implemented in Union policies should also be considered when assessing the 
severity of the harm that an AI system can cause, including in relation to the health and 
safety of persons.
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(29) As regards high-risk AI systems that are safety components of products or systems, or which 
are themselves products or systems falling within the scope of Regulation (EC) No 300/2008 
of the European Parliament and of the Council10, Regulation (EU) No 167/2013 of the 
European Parliament and of the Council11, Regulation (EU) No 168/2013 of the European 
Parliament and of the Council12, Directive 2014/90/EU of the European Parliament and of 
the Council13, Directive (EU) 2016/797 of the European Parliament and of the Council14
, 
Regulation (EU) 2018/858 of the European Parliament and of the Council15, Regulation 
(EU) 2018/1139 of the European Parliament and of the Council16, and Regulation (EU) 
2019/2144 of the European Parliament and of the Council17, it is appropriate to amend those 
acts to ensure that the Commission takes into account, on the basis of the technical and 
regulatory specificities of each sector, and without interfering with existing governance, 
conformity assessment and enforcement mechanisms and authorities established therein, the 
mandatory requirements for high-risk AI systems laid down in this Regulation when 
adopting any relevant future delegated or implementing acts on the basis of those acts.
 
10 Regulation (EC) No 300/2008 of the European Parliament and of the Council of 11 March 2008 on common 
rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (OJ L 97, 9.4.2008, p. 
72).
11 Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the 
approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1).
12 Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the 
approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52).
13 Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment 
and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146).
14 Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the 
interoperability of the rail system within the European Union (OJ L 138, 26.5.2016, p. 44).
15 Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and 
market surveillance of motor vehicles and their trailers, and of systems, components and separate technical 
units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and 
repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1).
16 Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in 
the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending 
Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 
2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) 
No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation 
(EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1).
17 Regulation (EU) 2019/2144 of the European Parliament and of the Council of 27 November 2019 on typeapproval requirements for motor vehicles and their trailers, and systems, components and separate technical 
units intended for such vehicles, as regards their general safety and the protection of vehicle occupants and 
vulnerable road users, amending Regulation (EU) 2018/858 of the European Parliament and of the Council and 
repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the European Parliament 
and of the Council and Commission Regulations (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, 
(EU) No 1003/2010, (EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) 
No 109/2011, (EU) No 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 
351/2012, (EU) No 1230/2012 and (EU) 2015/166 (OJ L 325, 16.12.2019, p. 1).
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(30) As regards AI systems that are safety components of products, or which are themselves 
products, falling within the scope of certain Union harmonisation legislation, it is 
appropriate to classify them as high-risk under this Regulation if the product in question 
undergoes the conformity assessment procedure with a third-party conformity assessment 
body pursuant to that relevant Union harmonisation legislation. In particular, such products 
are machinery, toys, lifts, equipment and protective systems intended for use in potentially 
explosive atmospheres, radio equipment, pressure equipment, recreational craft equipment, 
cableway installations, appliances burning gaseous fuels, medical devices, and in vitro 
diagnostic medical devices.
(31) The classification of an AI system as high-risk pursuant to this Regulation should not 
necessarily mean that the product whose safety component is the AI system, or the AI 
system itself as a product, is considered ‘high-risk’ under the criteria established in the 
relevant Union harmonisation legislation that applies to the product. This is notably the case 
for Regulation (EU) 2017/745 of the European Parliament and of the Council18 and 
Regulation (EU) 2017/746 of the European Parliament and of the Council19, where a thirdparty conformity assessment is provided for medium-risk and high-risk products. 
 
18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices,
amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and 
repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
19 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro 
diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 
117, 5.5.2017, p. 176).
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(32) As regards high-risk AI systems other than those that are safety components of products, or 
which are themselves products, it is appropriate to classify them as high-risk if, in the light 
of their intended purpose, they pose a high risk of harm to the health and safety or the 
fundamental rights of persons, taking into account both the severity of the possible harm and 
its probability of occurrence, and they are used in a number of specifically pre-defined areas 
specified in the Regulation. The identification of those systems is based on the same 
methodology and criteria envisaged also for any future amendments of the list of high-risk 
AI systems. It is also important to clarify that within the high-risk scenarios referred to in 
Annex III there may be systems that do not lead to a significant risk to the legal interests 
protected under those scenarios, taking into account the output produced by the AI system. 
Therefore only when such output has a high degree of importance (i.e. is not purely 
accessory) in respect of the relevant action or decision so as to generate a significant risk to 
the legal interests protected, the AI system generating such output should be considered as 
high-risk. For instance, when the information provided by an AI systems to the human 
consists of the profiling of natural persons within the meaning of of Article 4(4) Regulation 
(EU) 2016/679 and Article 3(4) of Directive (EU) 2016/680 and Article 3(5) of Regulation 
(EU) 2018/1725, such information should not typically be considered of accessory nature in 
the context of high risk AI systems as referred to in Annex III. However, if the output of the 
AI system has only negligible or minor relevance for human action or decision, it may be 
considered purely accessory, including for example, AI systems used for translation for 
informative purposes or for the management of documents. 
(33) Technical inaccuracies of AI systems intended for the remote biometric identification of 
natural persons can lead to biased results and entail discriminatory effects. This is 
particularly relevant when it comes to age, ethnicity, race, sex or disabilities. Therefore, 
‘real-time’ and ‘post’ remote biometric identification systems should be classified as highrisk. In view of the risks that they pose, both types of remote biometric identification 
systems should be subject to specific requirements on logging capabilities and human 
oversight.
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(34) As regards the management and operation of critical infrastructure, it is appropriate to 
classify as high-risk the AI systems intended to be used as safety components in the 
management and operation of critical digital infrastructure as listed in Annex I point 8 of the 
Directive on the resilience of critical entities, road traffic and the supply of water, gas, 
heating and electricity, since their failure or malfunctioning may put at risk the life and 
health of persons at large scale and lead to appreciable disruptions in the ordinary conduct of 
social and economic activities. Safety components of critical infrastructure, including 
critical digital infrastrucure, are systems used to directly protect the physical integrity of 
critical infrastructure or health and safety of persons and property but which are not 
necessary in order for the system to function. Failure or malfunctioning of such components
might directly lead to risks to the physical integrity of critical infrastructure and thus to risks 
to health and safety of persons and property. Components intended to be used solely for 
cybersecurity purposes should not qualify as safety components. Examples of safety 
components of such critical infrastructure may include systems for monitoring water 
pressure or fire alarm controlling systems in cloud computing centres.
(35) AI systems used in education or vocational training, notably for determining access, 
admission or assigning persons to educational and vocational training institutions or 
programmes at all levels or to evaluate learning outcomes of persons should be considered 
high-risk, since they may determine the educational and professional course of a person’s 
life and therefore affect their ability to secure their livelihood. When improperly designed 
and used, such systems may violate the right to education and training as well as the right 
not to be discriminated against and perpetuate historical patterns of discrimination.
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(36) AI systems used in employment, workers management and access to self-employment, 
notably for the recruitment and selection of persons, for making decisions on promotion and 
termination and for task allocation based on individual behavior or personal traits or 
characteristics, monitoring or evaluation of persons in work-related contractual 
relationships, should also be classified as high-risk, since those systems may appreciably 
impact future career prospects and livelihoods of these persons. Relevant work-related 
contractual relationships should involve employees and persons providing services through 
platforms as referred to in the Commission Work Programme 2021. Such persons should in 
principle not be considered users within the meaning of this Regulation. Throughout the 
recruitment process and in the evaluation, promotion, or retention of persons in work-related 
contractual relationships, such systems may perpetuate historical patterns of discrimination, 
for example against women, certain age groups, persons with disabilities, or persons of 
certain racial or ethnic origins or sexual orientation. AI systems used to monitor the 
performance and behaviour of these persons may also impact their rights to data protection 
and privacy. 
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(37) Another area in which the use of AI systems deserves special consideration is the access to 
and enjoyment of certain essential private and public services and benefits necessary for 
people to fully participate in society or to improve one’s standard of living. In particular, AI 
systems used to evaluate the credit score or creditworthiness of natural persons should be 
classified as high-risk AI systems, since they determine those persons’ access to financial 
resources or essential services such as housing, electricity, and telecommunication services. 
AI systems used for this purpose may lead to discrimination of persons or groups and 
perpetuate historical patterns of discrimination, for example based on racial or ethnic 
origins, disabilities, age, sexual orientation, or create new forms of discriminatory impacts. 
Considering the very limited scale of the impact and the available alternatives on the market, 
it is appropriate to exempt AI systems for the purpose of creditworthiness assessment and 
credit scoring when put into service by micro or small entreprises, as defined in the Annex 
of Commission Recommendation 2003/361/EC for their own use. Natural persons applying 
for or receiving essential public assistance benefits and services from public authorities are 
typically dependent on those benefits and services and in a vulnerable position in relation to 
the responsible authorities. If AI systems are used for determining whether such benefits and 
services should be denied, reduced, revoked or reclaimed by authorities, including whether 
beneficiaries are legitimately entitled to such benefits or services, those systems may have a 
significant impact on persons’ livelihood and may infringe their fundamental rights, such as 
the right to social protection, non-discrimination, human dignity or an effective remedy. 
Those systems should therefore be classified as high-risk. Nonetheless, this Regulation 
should not hamper the development and use of innovative approaches in the public 
administration, which would stand to benefit from a wider use of compliant and safe AI 
systems, provided that those systems do not entail a high risk to legal and natural persons. 
Finally, AI systems used to dispatch or establish priority in the dispatching of emergency 
first response services should also be classified as high-risk since they make decisions in 
very critical situations for the life and health of persons and their property. AI systems are 
also increasingly used for risk assessment in relation to natural persons and pricing in the 
case of life and health insurance which, if not duly designed, developed and used, can lead 
to serious consequences for people’s life and health, including financial exclusion and 
discrimination. To ensure a consistent approach within the financial services sector, the 
above mentioned exception for micro or small enterprises for their own use should apply, 
insofar as they themselves provide and put into service an AI system for the purpose of 
selling their own insurance products.
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38) Actions by law enforcement authorities involving certain uses of AI systems are 
characterised by a significant degree of power imbalance and may lead to surveillance, arrest 
or deprivation of a natural person’s liberty as well as other adverse impacts on fundamental 
rights guaranteed in the Charter. In particular, if the AI system is not trained with high 
quality data, does not meet adequate requirements in terms of its accuracy or robustness, or 
is not properly designed and tested before being put on the market or otherwise put into 
service, it may single out people in a discriminatory or otherwise incorrect or unjust manner. 
Furthermore, the exercise of important procedural fundamental rights, such as the right to an 
effective remedy and to a fair trial as well as the right of defence and the presumption of 
innocence, could be hampered, in particular, where such AI systems are not sufficiently 
transparent, explainable and documented. It is therefore appropriate to classify as high-risk a 
number of AI systems intended to be used in the law enforcement context where accuracy, 
reliability and transparency is particularly important to avoid adverse impacts, retain public 
trust and ensure accountability and effective redress. In view of the nature of the activities in 
question and the risks relating thereto, those high-risk AI systems should include in 
particular AI systems intended to be used by law enforcement authorities for individual risk 
assessments, polygraphs and similar tools or to detect the emotional state of natural person, 
for the evaluation of the reliability of evidence in criminal proceedings, for predicting the 
occurrence or reoccurrence of an actual or potential criminal offence based on profiling of 
natural persons, or assessing personality traits and characteristics or past criminal behaviour 
of natural persons or groups, for profiling in the course of detection, investigation or 
prosecution of criminal offences. AI systems specifically intended to be used for 
administrative proceedings by tax and customs authorities as well as by financial 
intelligence units carrying out adminstrative tasks analysing information pursuant to Union 
anti-money laundering legislation should not be considered high-risk AI systems used by 
law enforcement authorities for the purposes of prevention, detection, investigation and 
prosecution of criminal offences.
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(39) AI systems used in migration, asylum and border control management affect people who are 
often in particularly vulnerable position and who are dependent on the outcome of the 
actions of the competent public authorities. The accuracy, non-discriminatory nature and 
transparency of the AI systems used in those contexts are therefore particularly important to 
guarantee the respect of the fundamental rights of the affected persons, notably their rights 
to free movement, non-discrimination, protection of private life and personal data, 
international protection and good administration. It is therefore appropriate to classify as 
high-risk AI systems intended to be used by the competent public authorities charged with 
tasks in the fields of migration, asylum and border control management as polygraphs and 
similar tools or to detect the emotional state of a natural person; for assessing certain risks 
posed by natural persons entering the territory of a Member State or applying for visa or 
asylum; for assisting competent public authorities for the examination of applications for 
asylum, visa and residence permits and associated complaints with regard to the objective to 
establish the eligibility of the natural persons applying for a status. AI systems in the area of 
migration, asylum and border control management covered by this Regulation should 
comply with the relevant procedural requirements set by the Directive 2013/32/EU of the 
European Parliament and of the Council20, the Regulation (EC) No 810/2009 of the 
European Parliament and of the Council21 and other relevant legislation.
 
20 Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures
for granting and withdrawing international protection (OJ L 180, 29.6.2013, p. 60).
21 Regulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a 
Community Code on Visas (Visa Code) (OJ L 243, 15.9.2009, p. 1).
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(40) Certain AI systems intended for the administration of justice and democratic processes 
should be classified as high-risk, considering their potentially significant impact on 
democracy, rule of law, individual freedoms as well as the right to an effective remedy and 
to a fair trial. In particular, to address the risks of potential biases, errors and opacity, it is 
appropriate to qualify as high-risk AI systems intended to assist judicial authorities in 
interpreting facts and the law and in applying the law to a concrete set of facts. Such 
qualification should not extend, however, to AI systems intended for purely ancillary 
administrative activities that do not affect the actual administration of justice in individual 
cases, such as anonymisation or pseudonymisation of judicial decisions, documents or data, 
communication between personnel, administrative tasks.
(41) The fact that an AI system is classified as high risk under this Regulation should not be 
interpreted as indicating that the use of the system is lawful under other acts of Union law or 
under national law compatible with Union law, such as on the protection of personal data, on 
the use of polygraphs and similar tools or other systems to detect the emotional state of 
natural persons. Any such use should continue to occur solely in accordance with the 
applicable requirements resulting from the Charter and from the applicable acts of secondary 
Union law and national law. This Regulation should not be understood as providing for the 
legal ground for processing of personal data, including special categories of personal data, 
where relevant, unless it is specifically provided for otherwise in this Regulation.
(42) To mitigate the risks from high-risk AI systems placed or otherwise put into service on the 
Union market, certain mandatory requirements should apply, taking into account the 
intended purpose of the use of the system and according to the risk management system to 
be established by the provider. In particular, the risk management system should consist of a 
continuous iterative process planned and run throughout the entire lifecycle of a high-risk AI 
system. This process should ensure that the provider identifies and analyses the risks to the 
health, safety and fundamental rights of the persons who may be affected by the system in 
light of its intended purpose, including the possible risks arising from the interaction 
between the AI system and the environment within which it operates, and accordingly 
adopts suitable risk management measures in the light of state of the art.
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(43) Requirements should apply to high-risk AI systems as regards the quality of data sets used, 
technical documentation and record-keeping, transparency and the provision of information 
to users, human oversight, and robustness, accuracy and cybersecurity. Those requirements 
are necessary to effectively mitigate the risks for health, safety and fundamental rights, as 
applicable in the light of the intended purpose of the system, and no other less trade 
restrictive measures are reasonably available, thus avoiding unjustified restrictions to trade. 
(44) High data quality is essential for the performance of many AI systems, especially when 
techniques involving the training of models are used, with a view to ensure that the high-risk 
AI system performs as intended and safely and it does not become the source of 
discrimination prohibited by Union law. High quality training, validation and testing data 
sets require the implementation of appropriate data governance and management practices. 
Training, validation and testing data sets should be sufficiently relevant, representative and 
have the appropriate statistical properties, including as regards the persons or groups of 
persons on which the high-risk AI system is intended to be used. These datasets should also 
be as free of errors and complete as possible in view of the intended purpose of the AI 
system, taking into account, in a proportionate manner, technical feasibility and state of the 
art, the availability of data and the implementation of appropriate risk management measures 
so that possible shortcomings of the datasets are duly addressed. The requirement for the 
datasets to be complete and free of errors should not affect the use of privacy-preserving 
techniques in the context of the the development and testing of AI systems. Training, 
validation and testing data sets should take into account, to the extent required by their 
intended purpose, the features, characteristics or elements that are particular to the specific 
geographical, behavioural or functional setting or context within which the AI system is 
intended to be used. In order to protect the right of others from the discrimination that might 
result from the bias in AI systems, the providers should be able to process also special 
categories of personal data, as a matter of substantial public interest within the meaning of
Article 9(2)(g) of Regulation (EU) 2016/679 and Article 10(2)g) of Regulation (EU) 
2018/1725, in order to ensure the bias monitoring, detection and correction in relation to 
high-risk AI systems.
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(44a) When applying the principles referred to in Article 5(1)(c) of Regulation 2016/679 and 
Article 4(1)(c) of Regulation 2018/1725, in particular the principle of data minimisation, in 
regard to training, validation and testing data sets under this Regulation, due regard should 
be had to the full life cycle of the AI system.
(45) For the development of high-risk AI systems, certain actors, such as providers, notified 
bodies and other relevant entities, such as digital innovation hubs, testing experimentation 
facilities and researchers, should be able to access and use high quality datasets within their 
respective fields of activities which are related to this Regulation. European common data 
spaces established by the Commission and the facilitation of data sharing between 
businesses and with government in the public interest will be instrumental to provide 
trustful, accountable and non-discriminatory access to high quality data for the training, 
validation and testing of AI systems. For example, in health, the European health data space 
will facilitate non-discriminatory access to health data and the training of artificial 
intelligence algorithms on those datasets, in a privacy-preserving, secure, timely, transparent 
and trustworthy manner, and with an appropriate institutional governance. Relevant 
competent authorities, including sectoral ones, providing or supporting the access to data 
may also support the provision of high-quality data for the training, validation and testing of 
AI systems.
(46) Having information on how high-risk AI systems have been developed and how they 
perform throughout their lifecycle is essential to verify compliance with the requirements 
under this Regulation. This requires keeping records and the availability of a technical 
documentation, containing information which is necessary to assess the compliance of the 
AI system with the relevant requirements. Such information should include the general 
characteristics, capabilities and limitations of the system, algorithms, data, training, testing 
and validation processes used as well as documentation on the relevant risk management 
system. The technical documentation should be kept up to date. Furthermore, providers or 
users should keep logs automatically generated by the high-risk AI system, including for 
instance output data, start date and time etc., to the extent that such a system and the related 
logs are under their control, for a period that is appropriate to enable them to fulfil their 
obligations.
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(47) To address the opacity that may make certain AI systems incomprehensible to or too 
complex for natural persons, a certain degree of transparency should be required for highrisk AI systems. Users should be able to interpret the system output and use it appropriately. 
High-risk AI systems should therefore be accompanied by relevant documentation and 
instructions of use and include concise and clear information, including in relation to 
possible risks to fundamental rights and discrimination of the persons who may be affected
by the system in light of its intended purpose, where appropriate. To facilitate the 
understanding of the instructions of use by users, they should contain illustrative examples, 
as appropriate.
(48) High-risk AI systems should be designed and developed in such a way that natural persons 
can oversee their functioning. For this purpose, appropriate human oversight measures 
should be identified by the provider of the system before its placing on the market or putting 
into service. In particular, where appropriate, such measures should guarantee that the 
system is subject to in-built operational constraints that cannot be overridden by the system 
itself and is responsive to the human operator, and that the natural persons to whom human 
oversight has been assigned have the necessary competence, training and authority to carry 
out that role. Considering the significant consequences for persons in case of incorrect 
matches by certain biometric identification systems, it is appropriate to provide for an 
enhanced human oversight requirement for those systems so that no action or decision may 
be taken by the user on the basis of the identification resulting from the system unless this 
has been separately verified and confirmed by at least two natural persons. Those persons 
could be from one or more entities and include the person operating or using the system. 
This requirement should not pose unnecessary burden or delays and it could be sufficient 
that the separate verifications by the different persons are automatically recorded in the logs 
generated by the system.
(49) High-risk AI systems should perform consistently throughout their lifecycle and meet an 
appropriate level of accuracy, robustness and cybersecurity in accordance with the generally 
acknowledged state of the art. The level of accuracy and accuracy metrics should be 
communicated to the users. 
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(50) The technical robustness is a key requirement for high-risk AI systems. They should be 
resilient in relation to harmful or otherwise undesirable behaviour that may result from 
limitations within the systems or the environment in which the systems operate (e.g. errors, 
faults, inconsistencies, unexpected situations). High-risk AI systems should therefore be 
designed and developed with appropriate technical solutions to prevent or minimize that 
harmful or otherwise undesirable behaviour, such as for instance mechanisms enabling the 
system to safely interrupt its operation (fail-safe plans) in the presence of certain anomalies 
or when operation takes place outside certain predetermined boundaries. Failure to protect 
against these risks could lead to safety impacts or negatively affect the fundamental rights, 
for example due to erroneous decisions or wrong or biased outputs generated by the AI 
system.
(51) Cybersecurity plays a crucial role in ensuring that AI systems are resilient against attempts 
to alter their use, behaviour, performance or compromise their security properties by 
malicious third parties exploiting the system’s vulnerabilities. Cyberattacks against AI 
systems can leverage AI specific assets, such as training data sets (e.g. data poisoning) or 
trained models (e.g. adversarial attacks), or exploit vulnerabilities in the AI system’s digital 
assets or the underlying ICT infrastructure. To ensure a level of cybersecurity appropriate to 
the risks, suitable measures should therefore be taken by the providers of high-risk AI 
systems, also taking into account as appropriate the underlying ICT infrastructure.
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(52) As part of Union harmonisation legislation, rules applicable to the placing on the market, 
putting into service and use of high-risk AI systems should be laid down consistently with 
Regulation (EC) No 765/2008 of the European Parliament and of the Council22 setting out 
the requirements for accreditation and the market surveillance of products, Decision No 
768/2008/EC of the European Parliament and of the Council23 on a common framework for 
the marketing of products and Regulation (EU) 2019/1020 of the European Parliament and 
of the Council24 on market surveillance and compliance of products (‘New Legislative 
Framework for the marketing of products’).
(52a) In line with New Legislative Framework principles, specific obligations for relevant 
operators within the AI value chain should be set to ensure legal certainty and facilitate 
compliance with this Regulation. In certain situations those operators could act in more than 
one role at the same time and should therefore fufil cumulatively all relevant obligations 
associated with those roles. For example, an operator could act as a distributor and an 
importer at the same time. 
(53) It is appropriate that a specific natural or legal person, defined as the provider, takes the 
responsibility for the placing on the market or putting into service of a high-risk AI system, 
regardless of whether that natural or legal person is the person who designed or developed 
the system.
 
22 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the 
requirements for accreditation and market surveillance relating to the marketing of products and repealing 
Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
23 Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common 
framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, 
p. 82).
24 Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market 
surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 
765/2008 and (EU) No 305/2011 (Text with EEA relevance) (OJ L 169, 25.6.2019, p. 1–44).
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(54) The provider should establish a sound quality management system, ensure the 
accomplishment of the required conformity assessment procedure, draw up the relevant 
documentation and establish a robust post-market monitoring system. Public authorities 
which put into service high-risk AI systems for their own use may adopt and implement the 
rules for the quality management system as part of the quality management system adopted 
at a national or regional level, as appropriate, taking into account the specificities of the 
sector and the competences and organisation of the public authority in question. 
(54a) To ensure legal certainty, it is necessary to clarify that, under certain specific conditions, any 
natural or legal person should be considered a provider of a new high-risk AI system and 
therefore assume all the relevant obligations. For example, this would be the case if that 
person puts its name or trademark on a high-risk AI system already placed on the market or 
put into service, or if that person modifies the intended purpose of an AI system which is not 
high-risk and is already placed on the market or put into service, in a way that makes the 
modified system a high-risk AI system. These provisions should apply without prejudice to 
more specific provisions established in certain New Legislative Framework sectorial 
legislation with which this Regulation should apply jointly. For example, Article 16, 
paragraph 2 of Regulation 745/2017, establishing that certain changes should not be 
considered modifications of a device that could affect its compliance with the applicable 
requirements, should continue to apply to high-risk AI systems that are medical devices 
within the meaning of that Regulation.
(55) Where a high-risk AI system that is a safety component of a product which is covered by a 
relevant New Legislative Framework sectorial legislation is not placed on the market or put 
into service independently from the product, the product manufacturer as defined under the 
relevant New Legislative Framework legislation should comply with the obligations of the 
provider established in this Regulation and notably ensure that the AI system embedded in 
the final product complies with the requirements of this Regulation.
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(56) To enable enforcement of this Regulation and create a level-playing field for operators, and 
taking into account the different forms of making available of digital products, it is 
important to ensure that, under all circumstances, a person established in the Union can 
provide authorities with all the necessary information on the compliance of an AI system. 
Therefore, prior to making their AI systems available in the Union, where an importer 
cannot be identified, providers established outside the Union shall, by written mandate, 
appoint an authorised representative established in the Union. 
(56a) For providers who are not established in the Union, the authorised representative plays a 
pivotal role in ensuring the compliance of the high-risk AI systems placed on the market or 
put into service in the Union by those providers and in serving as their contact person 
established in the Union. Given that pivotal role, and in order to ensure that responsibility is 
assumed for the purposes of enforcement of this Regulation, it is appropriate to make the 
authorised representative jointly and severally liable with the provider for defective highrisk AI systems. The liability of the authorised representative provided for in this Regulation 
is without prejudice to the provisions of Directive 85/374/EEC on liability for defective 
products.
(57) [deleted]
(58) Given the nature of AI systems and the risks to safety and fundamental rights possibly 
associated with their use, including as regard the need to ensure proper monitoring of the 
performance of an AI system in a real-life setting, it is appropriate to set specific 
responsibilities for users. Users should in particular use high-risk AI systems in accordance 
with the instructions of use and certain other obligations should be provided for with regard 
to monitoring of the functioning of the AI systems and with regard to record-keeping, as 
appropriate. These obligations should be without prejudice to other user obligations in 
relation to high-risk AI systems under Union or national law, and should not apply where 
the use is made in the course of a personal non-professional activity.
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(58a) It is appropriate to clarify that this Regulation does not affect the obligations of providers 
and users of AI systems in their role as data controllers or processors stemming from Union 
law on the protection of personal data in so far as the design, the development or the use of 
AI systems involves the processing of personal data. It is also appropriate to clarify that data 
subjects continue to enjoy all the rights and guarantees awarded to them by such Union law, 
including the rights related to solely automated individual decision-making, including 
profiling. Harmonised rules for the placing on the market, the putting into service and the 
use of AI systems established under this Regulation should facilitate the effective 
implementation and enable the exercise of the data subjects’ rights and other remedies 
guaranteed under Union law on the protection of personal data and of other fundamental 
rights.
(59) [deleted]
(60) [deleted]
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(61) Standardisation should play a key role to provide technical solutions to providers to ensure 
compliance with this Regulation, in line with the state of the art. Compliance with 
harmonised standards as defined in Regulation (EU) No 1025/2012 of the European 
Parliament and of the Council25, which are normally expected to reflect the state of the 
art,should be a means for providers to demonstrate conformity with the requirements of this 
Regulation. However, in the absence of relevant references to harmonised standards, the 
Commission should be able to establish, via implementing acts, common specifications for 
certain requirements under this Regulation as an exceptional fall back solution to facilitate 
the provider’s obligation to comply with the requirements of this Regulation, when the 
standardisation process is blocked or when there are delays in the establishment of an 
appropriate harmonised standard. If such delay is due to the technical complexity of the 
standard in question, this should be considered by the Commission before contemplating the 
establishment of common specifications. An appropriate involvement of small and medium 
enterprises in the elaboration of standards supporting the implementation of this Regulation 
is essential to promote innovation and competitiveness in the field of artificial intelligence 
within the Union. Such involvement should be appropriately ensured in accordance with 
Article 5 and 6 of Regulation 1025/2012.
 
25 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on 
European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 
94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the 
European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 
1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
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(61a) It is appropriate that, without prejudice to the use of harmonised standards and common 
specifications, providers benefit from a presumption of conformity with the relevant 
requirement on data when their high-risk AI system has been trained and tested on data 
reflecting the specific geographical, behavioural or functional setting within which the AI 
system is intended to be used. Similarly, in line with Article 54(3) of Regulation (EU) 
2019/881 of the European Parliament and of the Council, high-risk AI systems that have 
been certified or for which a statement of conformity has been issued under a cybersecurity 
scheme pursuant to that Regulation and the references of which have been published in the 
Official Journal of the European Union should be presumed to be in compliance with the 
cybersecurity requirement of this Regulation. This remains without prejudice to the 
voluntary nature of that cybersecurity scheme.
(62) In order to ensure a high level of trustworthiness of high-risk AI systems, those systems 
should be subject to a conformity assessment prior to their placing on the market or putting 
into service.
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(63) It is appropriate that, in order to minimise the burden on operators and avoid any possible 
duplication, for high-risk AI systems related to products which are covered by existing 
Union harmonisation legislation following the New Legislative Framework approach, the 
compliance of those AI systems with the requirements of this Regulation should be assessed 
as part of the conformity assessment already foreseen under that legislation. The 
applicability of the requirements of this Regulation should thus not affect the specific logic, 
methodology or general structure of conformity assessment under the relevant specific New 
Legislative Framework legislation. This approach is fully reflected in the interplay between 
this Regulation and the [Machinery Regulation]. While safety risks of AI systems ensuring 
safety functions in machinery are addressed by the requirements of this Regulation, certain 
specific requirements in the [Machinery Regulation] will ensure the safe integration of the 
AI system into the overall machinery, so as not to compromise the safety of the machinery 
as a whole. The [Machinery Regulation] applies the same definition of AI system as this 
Regulation. With regard to high-risk AI systems related to products covered by Regulations 
745/2017 and 746/2017 on medical devices, the applicability of the requirements of this 
Regulation should be without prejudice and take into account the risk management logic and 
benefit-risk assessment performed under the medical device framework.
(64) Given the more extensive experience of professional pre-market certifiers in the field of 
product safety and the different nature of risks involved, it is appropriate to limit, at least in 
an initial phase of application of this Regulation, the scope of application of third-party 
conformity assessment for high-risk AI systems other than those related to products. 
Therefore, the conformity assessment of such systems should be carried out as a general rule 
by the provider under its own responsibility, with the only exception of AI systems intended 
to be used for the remote biometric identification of persons, for which the involvement of a 
notified body in the conformity assessment should be foreseen, to the extent they are not 
prohibited. 
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(65) In order to carry out third-party conformity assessment for AI systems intended to be used 
for the remote biometric identification of persons, notified bodies should be notified under 
this Regulation by the national competent authorities, provided they are compliant with a set 
of requirements, notably on independence, competence and absence of conflicts of interests. 
Notification of those bodies should be sent by national competent authorities to the 
Commission and the other Member States by means of the electronic notification tool 
developed and managed by the Commission pursuant to Article R23 of Decision 768/2008.
(66) In line with the commonly established notion of substantial modification for products 
regulated by Union harmonisation legislation, it is appropriate that whenever a change 
occurs which may affect the compliance of a high risk AI system with this Regulation (e.g. 
change of operating system or software architecture), or when the intended purpose of the 
system changes, that AI system should be considered a new AI system which should 
undergo a new conformity assessment. However, changes occuring to the algorithm and the 
performance of AI systems which continue to ‘learn’ after being placed on the market or put 
into service (i.e. automatically adapting how functions are carried out) should not constitute 
a substantial modification, provided that those changes have been pre-determined by the 
provider and assessed at the moment of the conformity assessment. 
(67) High-risk AI systems should bear the CE marking to indicate their conformity with this 
Regulation so that they can move freely within the internal market. Member States should 
not create unjustified obstacles to the placing on the market or putting into service of highrisk AI systems that comply with the requirements laid down in this Regulation and bear the 
CE marking.
(68) Under certain conditions, rapid availability of innovative technologies may be crucial for 
health and safety of persons and for society as a whole. It is thus appropriate that under 
exceptional reasons of public security or protection of life and health of natural persons and 
the protection of industrial and commercial property, Member States could authorise the 
placing on the market or putting into service of AI systems which have not undergone a 
conformity assessment.
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(69) In order to facilitate the work of the Commission and the Member States in the artificial 
intelligence field as well as to increase the transparency towards the public, providers of 
high-risk AI systems other than those related to products falling within the scope of relevant 
existing Union harmonisation legislation, should be required to register themselves and 
information about their high-risk AI system in a EU database, to be established and managed 
by the Commission. Before using a high-risk AI system listed in Annex III, users of highrisk AI systems that are public authorities, agencies or bodies, with the exception of law 
enforcement, border control, immigration or asylum authorities, and authorities that are 
users of high-risk AI systems in the area of critical infrastructure shall also register 
themselves in such database and select the system that they envisage to use. The 
Commission should be the controller of that database, in accordance with Regulation (EU) 
2018/1725 of the European Parliament and of the Council26. In order to ensure the full 
functionality of the database, when deployed, the procedure for setting the database should 
include the elaboration of functional specifications by the Commission and an independent 
audit report. 
 
26 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection 
of natural persons with regard to the processing of personal data and on the free movement of such data, and 
repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
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(70) Certain AI systems intended to interact with natural persons or to generate content may pose 
specific risks of impersonation or deception irrespective of whether they qualify as high-risk 
or not. In certain circumstances, the use of these systems should therefore be subject to 
specific transparency obligations without prejudice to the requirements and obligations for 
high-risk AI systems. In particular, natural persons should be notified that they are 
interacting with an AI system, unless this is obvious from the point of view of a natural 
person who is reasonably well-informed, observant and circumspect taking into account the 
circumstances and the context of use. When implementing such obligation, the 
characteristics of individuals belonging to vulnerable groups due to their age or disability 
should be taken into account to the extent the AI system is intended to interact with those 
groups as well. Moreover, natural persons should be notified when they are exposed to 
systems that, by processing their biometric data, can identify or infer the emotions or 
intentions of those persons or assign them to specific categories. Such specific categories 
can relate to aspects such as sex, age, hair colour, eye colour, tatoos, personal traits, ethnic 
origin, personal preferences and interests or to other aspects such as sexual or political 
orientation. Such information and notifications should be provided in accessible formats for 
persons with disabilities. Further, users, who use an AI system to generate or manipulate 
image, audio or video content that appreciably resembles existing persons, places or events 
and would falsely appear to a person to be authentic, should disclose that the content has
been artificially created or manipulated by labelling the artificial intelligence output 
accordingly and disclosing its artificial origin. The compliance with the information 
obligations referred to above should not be interpreted as indicating that the use of the 
system or its output is lawful under this Regulation or other Union and Member State law
and should be without prejudice to other transparency obligations for users of AI systems 
laid down in Union or national law. Furthermore it should also not be interpreted as 
indicating that the use of the system or its output impedes the right to freedom of expression 
and the right to freedom of the arts and sciences guaranteed in the Charter of Funadamental 
Rights of the EU, in particular where the content is part of an evidently creative, satirical, 
artistic or fictional work or programme, subject to appropriate safeguards for the rights and 
freedoms of third parties.
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(71) Artificial intelligence is a rapidly developing family of technologies that requires novel 
forms of regulatory oversight and a safe space for experimentation, while ensuring 
responsible innovation and integration of appropriate safeguards and risk mitigation 
measures. To ensure a legal framework that is innovation-friendly, future-proof and resilient 
to disruption, national competent authorities from one or more Member States should be 
encouraged to establish artificial intelligence regulatory sandboxes to facilitate the 
development and testing of innovative AI systems under strict regulatory oversight before 
these systems are placed on the market or otherwise put into service. 
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(72) The objectives of the AI regulatory sandboxes should be to foster AI innovation by 
establishing a controlled experimentation and testing environment in the development and 
pre-marketing phase with a view to ensuring compliance of the innovative AI systems with 
this Regulation and other relevant Union and Member States legislation; to enhance legal 
certainty for innovators and the competent authorities’ oversight and understanding of the 
opportunities, emerging risks and the impacts of AI use, and to accelerate access to markets, 
including by removing barriers for small and medium enterprises (SMEs), including startups. The participation in the AI regulatory sandbox should focus on issues that raise legal 
uncertainty for providers and prospective providers to innovate, experiment with AI in the 
Union and contribute to evidence-based regulatory learning. The supervision of the AI 
systems in the AI regulatory sandbox should therefore cover their development, training, 
testing and validation before the systems are placed on the market or put into service, as well 
as the notion and occurrence of substantial modification that may require a new conformity 
assessment procedure. Where appropriate, national competent authorities establishing AI 
regulatory sandboxes should cooperate with other relevant authorities, including those 
supervising the protection of fundamental rights, and could allow for the involvement of 
other actors within the AI ecosystem such as national or European standardisation 
organisations, notified bodies, testing and experimentation facilities, research and 
experimentation labs, innovation hubs and relevant stakeholder and civil society 
organisations. To ensure uniform implementation across the Union and economies of scale, 
it is appropriate to establish common rules for the regulatory sandboxes’ implementation 
and a framework for cooperation between the relevant authorities involved in the 
supervision of the sandboxes. AI regulatory sandboxes established under this Regulation 
should be without prejudice to other legislation allowing for the establishment of other 
sandboxes aiming at ensuring compliance with legislation other that this Regulation. Where 
appropriate, relevant competent authorities in charge of those other regulatory sandboxes 
should consider the benefits of using those sandboxes also for the purpose of ensuring 
compliance of AI systems with this Regulation. Upon agreement between the national 
competent authorities and the participants in the AI regulatory sandbox, testing in real world 
conditions may also be operated and supervised in the framework of the AI regulatory 
sandbox.
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(-72a) This Regulation should provide the legal basis for the participants in the AI regulatory 
sandbox to use personal data collected for other purposes for developing certain AI systems 
in the public interest within the AI regulatory sandbox, in line with Article 6(4) and 9(2)(g) 
of Regulation (EU) 2016/679, and Article 5 and 10 of Regulation (EU) 2018/1725, and 
without prejudice to Articles 4(2) and 10 of Directive (EU) 2016/680. All other obligations 
of data controllers and rights of data subjects under Regulation (EU) 2016/679, Regulation 
(EU) 2018/1725 and Directive (EU) 2016/680 remain applicable. In particular, this 
Regulation should not provide a legal basis in the meaning of Article 22(2)(b) of Regulation 
(EU) 2016/679 and Article 24(2)(b) of Regulation (EU) 2018/1725. Participants in the 
sandbox should ensure appropriate safeguards and cooperate with the competent authorities, 
including by following their guidance and acting expeditiously and in good faith to mitigate 
any high-risks to safety and fundamental rights that may arise during the development and 
experimentation in the sandbox. The conduct of the participants in the sandbox should be 
taken into account when competent authorities decide whether to impose an administrative 
fine under Article 83(2) of Regulation 2016/679 and Article 57 of Directive 2016/680.
(72a) In order to accelerate the process of development and placing on the market of high-risk AI 
systems listed in Annex III, it is important that providers or prospective providers of such 
systems may also benefit from a specific regime for testing those systems in real world 
conditions, without participating in an AI regulatory sandbox. However, in such cases and 
taking into account the possible consequences of such testing on individuals, it should be 
ensured that appropriate and sufficient guarantees and conditions are introduced by the 
Regulation for providers or prospective providers. Such guarantees should include, among 
others, requesting informed consent of natural persons to participate in testing in real world 
conditions, with the exception of law enforcement in cases where the seeking of informed 
consent would prevent the AI system from being tested. Consent of subjects to participate in 
such testing under this Regulation is distinct from and without prejudice to consent of data 
subjects for the processing of their personal data under the relevant data protection law.
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(73) In order to promote and protect innovation, it is important that the interests of SME 
providers and users of AI systems are taken into particular account. To this objective, 
Member States should develop initiatives, which are targeted at those operators, including 
on awareness raising and information communication. Moreover, the specific interests and 
needs of SME providers shall be taken into account when notified bodies set conformity 
assessment fees. Translation costs related to mandatory documentation and communication 
with authorities may constitute a significant cost for providers and other operators, notably 
those of a smaller scale. Member States should possibly ensure that one of the languages 
determined and accepted by them for relevant providers’ documentation and for 
communication with operators is one which is broadly understood by the largest possible 
number of cross-border users.
(73a) In order to promote and protect innovation, the AI-on demand platform, all relevant EU 
funding programmes and projects, such as Digital Europe Programme, Horizon Europe, 
implemented by the Commission and the Member States at national or EU level should 
contribute to the achievement of the objectives of this Regulation. 
(74) In particular, in order to minimise the risks to implementation resulting from lack of 
knowledge and expertise in the market as well as to facilitate compliance of providers, 
notably SMEs, and notified bodies with their obligations under this Regulation, the AI-on 
demand platform, the European Digital Innovation Hubs and the Testing and 
Experimentation Facilities established by the Commission and the Member States at national 
or EU level should possibly contribute to the implementation of this Regulation. Within 
their respective mission and fields of competence, they may provide in particular technical 
and scientific support to providers and notified bodies.
(74a) Moreover, in order to ensure proportionality considering the very small size of some 
operators regarding costs of innovation, it is appropriate to exempt microenterprises from 
the most costly obligations, such as to establish a quality management system which would 
reduce the administrative burden and the costs for those enterprises without affecting the 
level of protection and the need for compliance with the requirements for high-risk AI 
systems.
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(75) It is appropriate that the Commission facilitates, to the extent possible, access to Testing and 
Experimentation Facilities to bodies, groups or laboratories established or accredited 
pursuant to any relevant Union harmonisation legislation and which fulfil tasks in the 
context of conformity assessment of products or devices covered by that Union 
harmonisation legislation. This is notably the case for expert panels, expert laboratories and 
reference laboratories in the field of medical devices pursuant to Regulation (EU) 2017/745 
and Regulation (EU) 2017/746. 
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(76) In order to facilitate a smooth, effective and harmonised implementation of this Regulation a 
European Artificial Intelligence Board should be established. The Board should reflect the 
various interests of the AI eco-system and be composed of representatives of the Member 
States. In order to ensure the involvement of relevant stakeholders, a standing subgroup of 
the Board should be created. The Board should be responsible for a number of advisory 
tasks, including issuing opinions, recommendations, advice or contributing to guidance on 
matters related to the implementation of this Regulation, including on enforcement matters, 
technical specifications or existing standards regarding the requirements established in this 
Regulation and providing advice to the Commission and the Member States and their 
national competent authorities on specific questions related to artificial intelligence. In order 
to give some flexibility to Member States in the designation of their representatives in the AI 
Board, such representatives may be any persons belonging to public entities who should 
have the relevant competences and powers to facilitate coordination at national level and 
contribute to the achievement of the Board's tasks. The Board should establish two standing 
sub-groups to provide a platform for cooperation and exchange among market surveillance 
authorities and notifying authorities on issues related respectively to market surveillance and 
notified bodies. The standing subgroup for market surveillance should act as the 
Administrative Cooperation Group (ADCO) for this Regulation in the meaning of Article 30 
of Regulation (EU) 2019/1020. In line with the role and tasks of the Commission pursuant to 
Article 33 of Regulation (EU) 2019/1020, the Commission should support the activities of 
the standing subgroup for market surveillance by undertaking market evaluations or studies, 
notably with a view to identifying aspects of this Regulation requiring specific and urgent 
coordination among market surveillance authorities. The Board may establish other standing 
or temporary sub-groups as appropriate for the purpose of examining specific issues. The 
Board should also cooperate, as appropriate, with relevant EU bodies, experts groups and 
networks active in the context of relevant EU legislation, including in particular those active 
under relevant EU regulation on data, digital products and services.
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(76a) The Commission should actively support the Member States and operators in the 
implementation and enforcement of this Regulation. In this regard it should develop 
guidelines on particular topics aiming at facilitating the application of this Regulation, while 
paying particular attention to the needs of SMEs and start-us in sectors most likely to be 
affected. In order to support adequate enforcement and the capacities of the Member States, 
Union testing facilities on AI and a pool of relevant experts should be established and made 
available to the Member States.
(77) Member States hold a key role in the application and enforcement of this Regulation. In this 
respect, each Member State should designate one or more national competent authorities for 
the purpose of supervising the application and implementation of this Regulation. Member 
States may decide to appoint any kind of public entity to perform the tasks of the national 
competent authorities within the meaning of this Regulation, in accordance with their 
specific national organisational characteristics and needs. 
(78) In order to ensure that providers of high-risk AI systems can take into account the 
experience on the use of high-risk AI systems for improving their systems and the design 
and development process or can take any possible corrective action in a timely manner, all 
providers should have a post-market monitoring system in place. This system is also key to 
ensure that the possible risks emerging from AI systems which continue to ‘learn’ after 
being placed on the market or put into service can be more efficiently and timely addressed. 
In this context, providers should also be required to have a system in place to report to the 
relevant authorities any serious incidents resulting from the use of their AI systems. 
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(79) In order to ensure an appropriate and effective enforcement of the requirements and 
obligations set out by this Regulation, which is Union harmonisation legislation, the system 
of market surveillance and compliance of products established by Regulation (EU) 
2019/1020 should apply in its entirety. Market surveillance authorities designated pursuant 
to this Regulation should have all enforcement powers under this Regulation and Regulation 
(EU) 2019/1020 and should exercise their powers and carry out their duties independently, 
impartially and without bias. Although the majority of AI systems are not subject to specific 
requirements and obligations under this Regualtion, market surveillance authorities may take 
measures in relation to all AI systems when they present a risk in accordance with this 
Regulation. Due to the specific nature of Union institutions, agencies and bodies falling 
within the scope of this Regulation, it is appropriate to designate the European Data 
Protection Supervisor as a competent market surveillance authority for them. This should be 
without prejudice to the designation of national competent authorities by the Member States. 
Market surveillance activities should not affect the ability of the supervised entities to carry 
out their tasks independently, when such independence is required by Union law.
(79a) This Regulation is without prejudice to the competences, tasks, powers and independence of 
relevant national public authorities or bodies which supervise the application of Union law 
protecting fundamental rights, including equality bodies and data protection authorities. 
Where necessary for their mandate, those national public authorities or bodies should also 
have access to any documentation created under this Regulation. A specific safeguard 
procedure should be set for ensuring adequate and timely enforcement against AI systems 
presenting a risk to health, safety and fundamental rights. The procedure for such AI 
systems presenting a risk should be applied to high-risk AI systems presenting a risk, 
prohibited systems which have been placed on the market, put into service or used in 
violation of the prohibited practices laid down in this Regulation and AI systems which have 
been made available in violation of the transparency requirements laid down in this 
Regulation and present a risk. 
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(80) Union legislation on financial services includes internal governance and risk management 
rules and requirements which are applicable to regulated financial institutions in the course 
of provision of those services, including when they make use of AI systems. In order to 
ensure coherent application and enforcement of the obligations under this Regulation and 
relevant rules and requirements of the Union financial services legislation, the authorities 
responsible for the supervision and enforcement of the financial services legislation should 
be designated as competent authorities for the purpose of supervising the implementation of 
this Regulation, including for market surveillance activities, as regards AI systems provided 
or used by regulated and supervised financial institutions unless Member States decide to 
designate another authority to fulfill these market surveillance tasks. Those competent 
authorities should have all powers under this Regulation and Regulation (EU) 2019/1020 on 
market surveillance to enforce the requirements and obligations of this Regulation, including 
powers to carry our ex post market surveillance activities that can be integrated, as 
appropriate, into their existing supervisory mechanisms and procedures under the relevant 
Union financial services legislation. It is appropriate to envisage that, when acting as market 
surveillance authorities under this Regulation, the national authorities responsible for the 
supervision of credit institutions regulated under Directive 2013/36/EU, which are 
participating in the Single Supervisory Mechanism (SSM) established by Council 
Regulation No 1024/2013, should report, without delay, to the European Central Bank any 
information identified in the course of their market surveillance activities that may be of 
potential interest for the European Central Bank’s prudential supervisory tasks as specified 
in that Regulation. To further enhance the consistency between this Regulation and the rules 
applicable to credit institutions regulated under Directive 2013/36/EU of the European 
Parliament and of the Council27, it is also appropriate to integrate some of the providers’ 
procedural obligations in relation to risk management, post marketing monitoring and 
documentation into the existing obligations and procedures under Directive 2013/36/EU. In 
order to avoid overlaps, limited derogations should also be envisaged in relation to the 
quality management system of providers and the monitoring obligation placed on users of 
high-risk AI systems to the extent that these apply to credit institutions regulated by 
Directive 2013/36/EU. The same regime should apply to insurance and re-insurance 
undertakings and insurance holding companies under Directive 2009/138/EU (Solvency II) 
 
27 Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity 
of credit institutions and the prudential supervision of credit institutions and investment firms, amending 
Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338).
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and the insurance intermediaries under Directive 2016/97/EU and other types of financial 
institutions subject to requirements regarding internal governance, arrangements or 
processes established pursuant to the relevant Union financial services legislation to ensure 
consistency and equal treatment in the financial sector.
(81) The development of AI systems other than high-risk AI systems in accordance with the 
requirements of this Regulation may lead to a larger uptake of trustworthy artificial 
intelligence in the Union. Providers of non-high-risk AI systems should be encouraged to 
create codes of conduct intended to foster the voluntary application of the requirements 
applicable to high-risk AI systems, adapted in light of the intended purpose of the systems 
and the lower risk involved. Providers should also be encouraged to apply on a voluntary 
basis additional requirements related, for example, to environmental sustainability, 
accessibility to persons with disability, stakeholders’ participation in the design and 
development of AI systems, and diversity of the development teams. The Commission may 
develop initiatives, including of a sectorial nature, to facilitate the lowering of technical 
barriers hindering cross-border exchange of data for AI development, including on data 
access infrastructure, semantic and technical interoperability of different types of data.
(82) It is important that AI systems related to products that are not high-risk in accordance with 
this Regulation and thus are not required to comply with the requirements set out herein are 
nevertheless safe when placed on the market or put into service. To contribute to this 
objective, the Directive 2001/95/EC of the European Parliament and of the Council28
 would 
apply as a safety net.
(83) In order to ensure trustful and constructive cooperation of competent authorities on Union 
and national level, all parties involved in the application of this Regulation should respect 
the confidentiality of information and data obtained in carrying out their tasks, in accordance 
with Union or national law. 
 
28 Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product 
safety (OJ L 11, 15.1.2002, p. 4).
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(84) Member States should take all necessary measures to ensure that the provisions of this 
Regulation are implemented, including by laying down effective, proportionate and 
dissuasive penalties for their infringement, and in respect of the ne bis in idem principle. For 
certain specific infringements, Member States should take into account the margins and 
criteria set out in this Regulation. The European Data Protection Supervisor should have the 
power to impose fines on Union institutions, agencies and bodies falling within the scope of 
this Regulation. 
(85) In order to ensure that the regulatory framework can be adapted where necessary, the power 
to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission 
to amend the Union harmonisation legislation listed in Annex II, the high-risk AI systems 
listed in Annex III, the provisions regarding technical documentation listed in Annex IV, the 
content of the EU declaration of conformity in Annex V, the provisions regarding the 
conformity assessment procedures in Annex VI and VII and the provisions establishing the 
high-risk AI systems to which the conformity assessment procedure based on assessment of 
the quality management system and assessment of the technical documentation should 
apply. It is of particular importance that the Commission carry out appropriate consultations 
during its preparatory work, including at expert level, and that those consultations be 
conducted in accordance with the principles laid down in the Interinstitutional Agreement of 
13 April 2016 on Better Law-Making29. In particular, to ensure equal participation in the 
preparation of delegated acts, the European Parliament and the Council receive all 
documents at the same time as Member States’ experts, and their experts systematically 
have access to meetings of Commission expert groups dealing with the preparation of 
delegated acts. Such consultations and advisory support should also be carried out in the 
framework of the activities of the AI Board and its subgroups.
 
29 OJ L 123, 12.5.2016, p. 1.
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(86) In order to ensure uniform conditions for the implementation of this Regulation, 
implementing powers should be conferred on the Commission. Those powers should be 
exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and 
of the Council30. It is of particular importance that, in accordance with the principles laid 
down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making, whenever 
broader expertise is needed in the early preparation of draft implementing acts, the 
Commission makes use of expert groups, consults targeted stakeholders or carries out public 
consultations, as appropriate. Such consultations and advisory support should also be carried 
out in the framework of the activities of the AI Board and its subgroups, including the 
preparation of implementing acts in relation to Articles 4, 4b and 6.
(87) Since the objective of this Regulation cannot be sufficiently achieved by the Member States 
and can rather, by reason of the scale or effects of the action, be better achieved at Union 
level, the Union may adopt measures in accordance with the principle of subsidiarity as set 
out in Article 5 TEU. In accordance with the principle of proportionality as set out in that 
Article, this Regulation does not go beyond what is necessary in order to achieve that 
objective.
(87a) In order to ensure legal certainty, ensure an appropriate adaptation period for operators and 
avoid disruption to the market, including by ensuring continuity of the use of AI systems, it 
is appropriate that this Regulation applies to the high-risk AI systems that have been placed 
on the market or put into service before the general date of application thereof, only if, from 
that date, those systems are subject to significant changes in their design or intended 
purpose. It is appropriate to clarify that, in this respect, the concept of significant change 
should be understood as equivalent in substance to the notion of substantial modification, 
which is used with regard only to high-risk AI systems as defined in this Regulation.
 
30 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying 
down the rules and general principles concerning mechanisms for control by the Member States of the 
Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p.13).
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(88) This Regulation should apply from … [OP – please insert the date established in Art. 85]. 
However, the infrastructure related to the governance and the conformity assessment system 
should be operational before that date, therefore the provisions on notified bodies and 
governance structure should apply from … [OP – please insert the date – three months 
following the entry into force of this Regulation]. In addition, Member States should lay 
down and notify to the Commission the rules on penalties, including administrative fines, 
and ensure that they are properly and effectively implemented by the date of application of 
this Regulation. Therefore the provisions on penalties should apply from [OP – please insert 
the date – twelve months following the entry into force of this Regulation].
(89) The European Data Protection Supervisor and the European Data Protection Board were 
consulted in accordance with Article 42(2) of Regulation (EU) 2018/1725 and delivered an 
opinion on […]”.
HAVE ADOPTED THIS REGULATION:
TITLE I
GENERAL PROVISIONS
Article 1
Subject matter
This Regulation lays down:
(a) harmonised rules for the placing on the market, the putting into service and the use of 
artificial intelligence systems (‘AI systems’) in the Union;
(a) prohibitions of certain artificial intelligence practices;
(b) specific requirements for high-risk AI systems and obligations for operators of such 
systems;
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(c) harmonised transparency rules for certain AI systems;
(d) rules on market monitoring, market surveillance and governance;
(e) measures in support of innovation.
Article 2
Scope
1. This Regulation applies to:
(a) providers placing on the market or putting into service AI systems in the Union, 
irrespective of whether those providers are physically present or established within 
the Union or in a third country;
(b) users of AI systems who are physically present or established within the Union;
(c) providers and users of AI systems who are physically present or established in a third 
country, where the output produced by the system is used in the Union;
(d) importers and distributors of AI systems; 
(e) product manufacturers placing on the market or putting into service an AI system 
together with their product and under their own name or trademark;
(f) authorised representatives of providers, which are established in the Union;
2. For AI systems classified as high-risk AI systems in accordance with Articles 6(1) and 6(2) 
related to products covered by Union harmonisation legislation listed in Annex II, section 
B only Article 84 of this Regulation shall apply. Article 53 shall apply only insofar as the 
requirements for high-risk AI systems under this Regulation have been integrated under 
that Union harmonisation legislation. 
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3. This Regulation shall not apply to AI systems if and insofar placed on the market, put into 
service, or used with or without modification of such systems for the purpose of activities 
which fall outside the scope of Union law, and in any event activities concerning military, 
defence or national security, regardless of the type of entity carrying out those activities. 
In addition, this Regulation shall not apply to AI systems which are not placed on the 
market or put into service in the Union, where the output is used in the Union for the 
purpose of activities which fall outside the scope of Union law, and in any event activities 
concerning military, defence or national security, regardless of the type of entity carrying 
out those activities.
4. This Regulation shall not apply to public authorities in a third country nor to international 
organisations falling within the scope of this Regulation pursuant to paragraph 1, where 
those authorities or organisations use AI systems in the framework of international 
agreements for law enforcement and judicial cooperation with the Union or with one or 
more Member States.
5. This Regulation shall not affect the application of the provisions on the liability of 
intermediary service providers set out in Chapter II, Section 4 of Directive 2000/31/EC of 
the European Parliament and of the Council31 [as to be replaced by the corresponding 
provisions of the Digital Services Act].
6. This Regulation shall not apply to AI systems, including their output, specifically developed 
and put into service for the sole purpose of scientific research and development.
7. This Regulation shall not apply to any research and development activity regarding AI 
systems.
8. This Regulation shall not apply to obligations of users who are natural persons using AI 
systems in the course of a purely personal non-professional activity, except Article 52.
 
31 Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of 
information society services, in particular electronic commerce, in the Internal Market ('Directive on electronic 
commerce') (OJ L 178, 17.7.2000, p. 1).
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Article 3
Definitions
For the purpose of this Regulation, the following definitions apply:
(1) ‘artificial intelligence system’ (AI system) means a system that is designed to operate with 
elements of autonomy and that, based on machine and/or human-provided data and inputs, 
infers how to achieve a given set of objectives using machine learning and/or logic- and 
knowledge based approaches, and produces system-generated outputs such as content 
(generative AI systems), predictions, recommendations or decisions, influencing the 
environments with which the AI system interacts;
(1a) ‘life cycle of an AI system’ means the duration of an AI system, from design through 
retirement. Without prejudice to the powers of the market surveillance authorities, such 
retirement may happen at any point in time during the post-market monitoring phase upon 
the decision of the provider and implies that the system may not be used further. An AI 
system lifecycle is also ended by a substantial modification to the AI system made by the 
provider or any other natural or legal person, in which case the substantially modified AI 
system shall be considered as a new AI system.
(1b) ‘general purpose AI system’ means an AI system that - irrespective of how it is placed on 
the market or put into service, including as open source software - is intended by the 
provider to perform generally applicable functions such as image and speech recognition, 
audio and video generation, pattern detection, question answering, translation and others; a 
general purpose AI system may be used in a plurality of contexts and be integrated in a 
plurality of other AI systems;
(2) ‘provider’ means a natural or legal person, public authority, agency or other body that 
develops an AI system or that has an AI system developed and places that system on the 
market or puts it into service under its own name or trademark, whether for payment or 
free of charge;
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(3) [deleted];
(3a) ‘small and medium-sized enterprise’ (SMEs) means an enterprise as defined in the Annex 
of Commission Recommendation 2003/361/EC concerning the definition of micro, small 
and medium-sized enterprises;
(4) ‘user’ means any natural or legal person, including a public authority, agency or other 
body, under whose authority the system is used;
(5) ‘authorised representative’ means any natural or legal person physically present or 
established in the Union who has received and accepted a written mandate from a provider 
of an AI system to, respectively, perform and carry out on its behalf the obligations and 
procedures established by this Regulation;
(5a) ‘product manufacturer’ means a manufacturer within the meaning of any of the Union 
harmonisation legislation listed in Annex II;
(6) ‘importer’ means any natural or legal person physically present or established in the Union 
that places on the market an AI system that bears the name or trademark of a natural or 
legal person established outside the Union;
(7) ‘distributor’ means any natural or legal person in the supply chain, other than the provider 
or the importer, that makes an AI system available on the Union market;
(8) ‘operator’ means the provider, the product manufacturer, the user, the authorised 
representative, the importer or the distributor;
(9) ‘placing on the market’ means the first making available of an AI system on the Union 
market;
(10) ‘making available on the market’ means any supply of an AI system for distribution or use 
on the Union market in the course of a commercial activity, whether in return for payment 
or free of charge;
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(11) ‘putting into service’ means the supply of an AI system for first use directly to the user or 
for own use in the Union for its intended purpose;
(12) ‘intended purpose’ means the use for which an AI system is intended by the provider, 
including the specific context and conditions of use, as specified in the information 
supplied by the provider in the instructions for use, promotional or sales materials and 
statements, as well as in the technical documentation; 
(13) ‘reasonably foreseeable misuse’ means the use of an AI system in a way that is not in 
accordance with its intended purpose, but which may result from reasonably foreseeable 
human behaviour or interaction with other systems;
(14) ‘safety component of a product or system’ means a component of a product or of a system 
which fulfils a safety function for that product or system or the failure or malfunctioning of 
which endangers the health and safety of persons or property;
(15) ‘instructions for use’ means the information provided by the provider to inform the user of 
in particular an AI system’s intended purpose and proper use;
(16) ‘recall of an AI system’ means any measure aimed at achieving the return to the provider 
or taking it out of service or disabling the use of an AI system made available to users;
(17) ‘withdrawal of an AI system’ means any measure aimed at preventing an AI system in the 
supply chain being made available on the market;
(18) ‘performance of an AI system’ means the ability of an AI system to achieve its intended 
purpose;
(19) ‘conformity assessment’ means the process of verifying whether the requirements set out 
in Title III, Chapter 2 of this Regulation relating to a high-risk AI system have been 
fulfilled; 
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(20) ‘notifying authority’ means the national authority responsible for setting up and carrying 
out the necessary procedures for the assessment, designation and notification of conformity 
assessment bodies and for their monitoring;
(21) ‘conformity assessment body’ means a body that performs third-party conformity 
assessment activities, including testing, certification and inspection;
(22) ‘notified body’ means a conformity assessment body designated in accordance with this 
Regulation and other relevant Union harmonisation legislation;
(23) ‘substantial modification’ means a change to the AI system following its placing on the 
market or putting into service which affects the compliance of the AI system with the 
requirements set out in Title III, Chapter 2 of this Regulation, or a modification to the 
intended purpose for which the AI system has been assessed. For high-risk AI systems that 
continue to learn after being placed on the market or put into service, changes to the highrisk AI system and its performance that have been pre-determined by the provider at the 
moment of the initial conformity assessment and are part of the information contained in 
the technical documentation referred to in point 2(f) of Annex IV, shall not constitute a 
substantial modification.
(24) ‘CE marking of conformity’ (CE marking) means a marking by which a provider indicates 
that an AI system is in conformity with the requirements set out in Title III, Chapter 2 or in 
Article 4b of this Regulation and other applicable Union legal act harmonising the 
conditions for the marketing of products (‘Union harmonisation legislation’) providing for 
its affixing;
(25) ‘post-market monitoring system’ means all activities carried out by providers of AI 
systems to collect and review experience gained from the use of AI systems they place on 
the market or put into service for the purpose of identifying any need to immediately apply 
any necessary corrective or preventive actions;
(26) ‘market surveillance authority’ means the national authority carrying out the activities and 
taking the measures pursuant to Regulation (EU) 2019/1020;
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(27) ‘harmonised standard’ means a European standard as defined in Article 2(1)(c) of 
Regulation (EU) No 1025/2012;
(28) ‘common specification’ means a set of technical specifications, as defined in point 4 of 
Article 2 of Regulation (EU) No 1025/2012 providing means to comply with certain 
requirements established under this Regulation;
(29) ‘training data’ means data used for training an AI system through fitting its learnable 
parameters;
(30) ‘validation data’ means data used for providing an evaluation of the trained AI system and 
for tuning its non-learnable parameters and its learning process, among other things, in 
order to prevent overfitting; whereas the validation dataset can be a separate dataset or part 
of the training dataset, either as a fixed or variable split;
(31) ‘testing data’ means data used for providing an independent evaluation of the trained and 
validated AI system in order to confirm the expected performance of that system before its 
placing on the market or putting into service; 
(32) ‘input data’ means data provided to or directly acquired by an AI system on the basis of 
which the system produces an output;
(33) ‘biometric data’ means personal data resulting from specific technical processing relating 
to the physical, physiological or behavioural characteristics of a natural person, such as 
facial images or dactyloscopic data;
(34) ‘emotion recognition system’ means an AI system for the purpose of identifying or 
inferring psychological states, emotions or intentions of natural persons on the basis of 
their biometric data;
(35) ‘biometric categorisation system’ means an AI system for the purpose of assigning natural 
persons to specific categories on the basis of their biometric data;
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(36) ‘remote biometric identification system’ means an AI system for the purpose of identifying 
natural persons typically at a distance, without their active involvement, through the 
comparison of a person’s biometric data with the biometric data contained in a reference 
data repository; 
(37) ‘‘real-time’ remote biometric identification system’ means a remote biometric 
identification system whereby the capturing of biometric data, the comparison and the 
identification all occur instantaneously or near instantaneously;
(38) [deleted]
(39) ‘publicly accessible space’ means any publicly or privately owned physical place 
accessible to an undetermined number of natural persons regardless of whether certain 
conditions or circumstances for access have been predetermined, and regardless of the 
potential capacity restrictions;
(40) ‘law enforcement authority’ means: 
(a) any public authority competent for the prevention, investigation, detection or 
prosecution of criminal offences or the execution of criminal penalties, including the 
safeguarding against and the prevention of threats to public security; or
(b) any other body or entity entrusted by Member State law to exercise public authority 
and public powers for the purposes of the prevention, investigation, detection or 
prosecution of criminal offences or the execution of criminal penalties, including the 
safeguarding against and the prevention of threats to public security;
(41) ‘law enforcement’ means activities carried out by law enforcement authorities or on their 
behalf for the prevention, investigation, detection or prosecution of criminal offences or the 
execution of criminal penalties, including the safeguarding against and the prevention of 
threats to public security;
(42) [deleted] 
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(43) ‘national competent authority’ means any of the following: the notifying authority and the 
market surveillance authority. As regards AI systems put into service or used by EU 
institutions, agencies, offices and bodies, the European Data Protection Supervisor shall 
fulfil the responsibilities that in the Member States are entrusted to the national competent 
authority and, as relevant, any reference to national competent authorities or market 
surveillance authorities in this Regulation shall be understood as referring to the European 
Data Protection Supervisor;
(44) ‘serious incident’ means any incident or malfunctioning of an AI system that directly or 
indirectly leads to any of the following:
(a) the death of a person or serious damage to a person’s health;
(b) a serious and irreversible disruption of the management and operation of critical 
infrastructure;
(c) breach of obligations under Union law intended to protect fundamental rights;
(d) serious damage to property or the environment.
(45) ‘critical infrastructure’ means an asset, system or part thereof which is necessary for the 
delivery of a service that is essential for the maintenance of vital societal functions or 
economic activities within the meaning of Article 2(4) and (5) of Directive …../….. on the 
resilience of critical entities;
(46) ‘personal data’ means data as defined in point (1) of Article 4 of Regulation (EU) 
2016/679;
(47) ‘non-personal data’ means data other than personal data as defined in point (1) of Article 4 
of Regulation (EU) 2016/679;
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(48) ‘testing in real world conditions’ means the temporary testing of an AI system for its 
intended purpose in real world conditions outside of a laboratory or otherwise simulated 
environment with a view to gathering reliable and robust data and to assessing and 
verifying the conformity of the AI system with the requirements of this Regulation; testing 
in real world conditions shall not be considered as placing the AI system on the market or 
putting it into service within the meaning of this Regulation, provided that all conditions 
under Article 53 or Article 54a are fulfilled;
(49) ‘real world testing plan’ means a document that describes the objectives, methodology, 
geographical, population and temporal scope, monitoring, organisation and conduct of 
testing in real world conditions;
(50) ‘subject’ for the purpose of real world testing means a natural person who participates in 
testing in real world conditions;
(51) ‘informed consent’ means a subject's free and voluntary expression of his or her 
willingness to participate in a particular testing in real world conditions, after having been 
informed of all aspects of the testing that are relevant to the subject's decision to 
participate; in the case of minors and of incapacitated subjects, the informed consent shall 
be given by their legally designated representative;
(52) ‘AI regulatory sandbox’ means a concrete framework set up by a national competent 
authority which offers providers or prospective providers of AI systems the possibility to 
develop, train, validate and test, where appropriate in real world conditions, an innovative 
AI system, pursuant to a specific plan for a limited time under regulatory supervision.
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Article 4
Implementing acts
In order to ensure uniform conditions for the implementation of this Regulation as regards machine 
learning approaches and logic- and knowledged based approaches referred to in Article 3(1), the 
Commission may adopt implementing acts to specify the technical elements of those approaches, 
taking into account market and technological developments. Those implementing acts shall be 
adopted in accordance with the examination procedure referred to in Article 74(2). 
TITLE IA
GENERAL PURPOSE AI SYSTEMS
Article 4a
Compliance of general purpose AI systems with this Regulation
1. Without prejudice to Articles 5, 52, 53 and 69 of this Regulation, general purpose AI 
systems shall only comply with the requirements and obligations set out in Article 4b. 
2. Such requirements and obligations shall apply irrespective of whether the general 
purpose AI system is placed on the market or put into service as a pre-trained model 
and whether further fine-tuning of the model is to be performed by the user of the 
general purpose AI system.
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Article 4b
Requirements for general purpose AI systems and obligations for providers of such 
systems
1. General purpose AI systems which may be used as high risk AI systems or as 
components of high risk AI systems in the meaning of Article 6, shall comply with the 
requirements established in Title III, Chapter 2 of this Regulation as from the date of 
application of the implementing acts adopted by the Commission in accordance with 
the examination procedure referred to in Article 74(2) no later than 18 months after the 
entry into force of this Regulation. Those implementing acts shall specify and adapt the 
application of the requirements established in Title III, Chapter 2 to general purpose AI 
systems in the light of their characteristics, technical feasibility, specificities of the AI 
value chain and of market and technological developments. When fulfilling those 
requirements, the generally acknowledged state of the art shall be taken into account.
2. Providers of general purpose AI systems referred to in paragraph 1 shall comply, as 
from the date of application of the implementing acts referred to in paragraph 1, with 
the obligations set out in Articles 16aa, 16e, 16f, 16g, 16i, 16j, 25, 48 and 61.
3. For the purpose of complying with the obligations set out in Article 16e, providers 
shall follow the conformity assessment procedure based on internal control set out in 
Annex VI, points 3 and 4.
4. Providers of such systems shall also keep the technical documentation referred to in 
Article 11 at the disposal of the national competent authorities for a period ending ten 
years after the general purpose AI system is placed on the Union market or put into 
service in the Union.
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5. Providers of general purpose AI systems shall cooperate with and provide the 
necessary information to other providers intending to put into service or place such 
systems on the Union market as high-risk AI systems or as components of high-risk AI 
systems, with a view to enabling the latter to comply with their obligations under this 
Regulation. Such cooperation between providers shall preserve, as appropriate, 
intellectual property rights, and confidential business information or trade secrets in 
accordance with Article 70. In order to ensure uniform conditions for the 
implementation of this Regulation as regards the information to be shared by the 
providers of general purpose AI systems, the Commission may adopt implementing 
acts in accordance with the examination procedure referred to in Article 74(2).
6. In complying with the requirements and obligations referred to in paragraphs 1, 2 and 
3:
- any reference to the intended purpose shall be understood as referring to possible use 
of the general purpose AI systems as high risk AI systems or as components of AI high 
risk systems in the meaning of Article 6;
- any reference to the requirements for high-risk AI systems in Chapter II, Title III shall 
be understood as referring only to the requirements set out in the present Article.
Article 4c
Exceptions to Article 4b
1. Article 4b shall not apply when the provider has explicitly excluded all high-risk uses 
in the instructions of use or information accompanying the general purpose AI system.
2. Such exclusion shall be made in good faith and shall not be deemed justified if the 
provider has sufficient reasons to consider that the system may be misused.
3. When the provider detects or is informed about market misuse they shall take all 
necessary and proportionate measures to prevent such further misuse, in particular 
taking into account the scale of the misuse and the seriousness of the associated risks. 
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TITLE II
PROHIBITED ARTIFICIAL INTELLIGENCE PRACTICES
Article 5
1. The following artificial intelligence practices shall be prohibited:
(a) the placing on the market, putting into service or use of an AI system that deploys 
subliminal techniques beyond a person’s consciousness with the objective to or the 
effect of materially distorting a person’s behaviour in a manner that causes or is 
reasonably likely to cause that person or another person physical or psychological
harm;
(b) the placing on the market, putting into service or use of an AI system that exploits 
any of the vulnerabilities of a specific group of persons due to their age, disability or 
a specific social or economic situation, with the objective to or the effect of 
materially distorting the behaviour of a person pertaining to that group in a manner 
that causes or is reasonably likely to cause that person or another person physical or 
psychological harm;
(c) the placing on the market, putting into service or use of AI systems for the evaluation 
or classification of natural persons over a certain period of time based on their social 
behaviour or known or predicted personal or personality characteristics, with the 
social score leading to either or both of the following:
(i) detrimental or unfavourable treatment of certain natural persons or groups 
thereof in social contexts which are unrelated to the contexts in which the data 
was originally generated or collected; 
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(ii) detrimental or unfavourable treatment of certain natural persons or groups 
thereof that is unjustified or disproportionate to their social behaviour or its 
gravity;
(d) the use of ‘real-time’ remote biometric identification systems in publicly accessible 
spaces by law enforcement authorities or on their behalf for the purpose of law 
enforcement, unless and in as far as such use is strictly necessary for one of the 
following objectives:
(i) the targeted search for specific potential victims of crime; 
(ii) the prevention of a specific and substantial threat to the critical infrastructure, 
life, health or physical safety of natural persons or the prevention of terrorist 
attacks; 
(iii) the localisation or identification of a natural person for the purposes of 
conducting a criminal investigation, prosecution or executing a criminal 
penalty for offences, referred to in Article 2(2) of Council Framework Decision 
2002/584/JHA32 and punishable in the Member State concerned by a custodial 
sentence or a detention order for a maximum period of at least three years, or 
other specific offences punishable in the Member State concerned by a 
custodial sentence or a detention order for a maximum period of at least five 
years, as determined by the law of that Member State.
2. The use of ‘real-time’ remote biometric identification systems in publicly accessible spaces 
for the purpose of law enforcement for any of the objectives referred to in paragraph 1 
point d) shall take into account the following elements:
(a) the nature of the situation giving rise to the possible use, in particular the seriousness, 
probability and scale of the harm caused in the absence of the use of the system; 
 
32 Council Framework Decision 2002/584/JHA of 13 June 2002 on the European arrest warrant and the surrender 
procedures between Member States (OJ L 190, 18.7.2002, p. 1).
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(b) the consequences of the use of the system for the rights and freedoms of all persons 
concerned, in particular the seriousness, probability and scale of those consequences.
In addition, the use of ‘real-time’ remote biometric identification systems in publicly 
accessible spaces for the purpose of law enforcement for any of the objectives referred to 
in paragraph 1 point d) shall comply with necessary and proportionate safeguards and 
conditions in relation to the use, in particular as regards the temporal, geographic and 
personal limitations.
3. As regards paragraphs 1, point (d) and 2, each use for the purpose of law enforcement of a 
‘real-time’ remote biometric identification system in publicly accessible spaces shall be 
subject to a prior authorisation granted by a judicial authority or by an independent 
administrative authority of the Member State in which the use is to take place, issued upon 
a reasoned request and in accordance with the detailed rules of national law referred to in 
paragraph 4. However, in a duly justified situation of urgency, the use of the system may 
be commenced without an authorisation provided that, such authorisation shall be 
requested without undue delay during use of the AI system, and if such authorisation is 
rejected, its use shall be stopped with immediate effect. 
The competent judicial or administrative authority shall only grant the authorisation where 
it is satisfied, based on objective evidence or clear indications presented to it, that the use 
of the ‘real-time’ remote biometric identification system at issue is necessary for and 
proportionate to achieving one of the objectives specified in paragraph 1, point (d), as 
identified in the request. In deciding on the request, the competent judicial or 
administrative authority shall take into account the elements referred to in paragraph 2. 
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4. A Member State may decide to provide for the possibility to fully or partially authorise the 
use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for 
the purpose of law enforcement within the limits and under the conditions listed in 
paragraphs 1, point (d), 2 and 3. That Member State shall lay down in its national law the 
necessary detailed rules for the request, issuance and exercise of, as well as supervision 
and reporting relating to, the authorisations referred to in paragraph 3. Those rules shall 
also specify in respect of which of the objectives listed in paragraph 1, point (d), including 
which of the criminal offences referred to in point (iii) thereof, the competent authorities 
may be authorised to use those systems for the purpose of law enforcement.
TITLE III
HIGH-RISK AI SYSTEMS
CHAPTER 1
CLASSIFICATION OF AI SYSTEMS AS HIGH-RISK
Article 6
Classification rules for high-risk AI systems
1. An AI system that is itself a product covered by the Union harmonisation legislation listed 
in Annex II shall be considered as high risk if it is required to undergo a third-party 
conformity assessment with a view to the placing on the market or putting into service of 
that product pursuant to the above mentioned legislation.
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2. An AI system intended to be used as a safety component of a product covered by the 
legislation referred to in paragraph 1 shall be considered as high risk if it is required to 
undergo a third-party conformity assessment with a view to the placing on the market or 
putting into service of that product pursuant to above mentioned legislation. This provision 
shall apply irrespective of whether the AI system is placed on the market or put into 
service independently from the product. 
3. AI systems referred to in Annex III shall be considered high-risk unless the output of the 
system is purely accessory in respect of the relevant action or decision to be taken and is 
not therefore likely to lead to a significant risk to the health, safety or fundamental rights.
In order to ensure uniform conditions for the implementation of this Regulation, the 
Commission shall, no later than one year after the entry into force of this Regulation, adopt 
implementing acts to specify the circumstances where the output of AI systems referred to 
in Annex III would be purely accessory in respect of the relevant action or decision to be 
taken. Those implementing acts shall be adopted in accordance with the examination 
procedure referred to in Article 74, paragraph 2.
Article 7
Amendments to Annex III
1. The Commission is empowered to adopt delegated acts in accordance with Article 73 to 
amend the list in Annex III by adding high-risk AI systems where both of the following 
conditions are fulfilled:
(a) the AI systems are intended to be used in any of the areas listed in points 1 to 8 of 
Annex III;
(b) the AI systems pose a risk of harm to the health and safety, or a risk of adverse 
impact on fundamental rights, that is, in respect of its severity and probability of 
occurrence, equivalent to or greater than the risk of harm or of adverse impact posed 
by the high-risk AI systems already referred to in Annex III.
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2. When assessing for the purposes of paragraph 1 whether an AI system poses a risk of harm 
to the health and safety or a risk of adverse impact on fundamental rights that is equivalent 
to or greater than the risk of harm posed by the high-risk AI systems already referred to in 
Annex III, the Commission shall take into account the following criteria:
(a) the intended purpose of the AI system;
(b) the extent to which an AI system has been used or is likely to be used;
(c) the extent to which the use of an AI system has already caused harm to the health and 
safety or adverse impact on the fundamental rights or has given rise to significant 
concerns in relation to the materialisation of such harm or adverse impact, as 
demonstrated by reports or documented allegations submitted to national competent 
authorities;
(d) the potential extent of such harm or such adverse impact, in particular in terms of its 
intensity and its ability to affect a plurality of persons;
(e) the extent to which potentially harmed or adversely impacted persons are dependent 
on the outcome produced with an AI system, in particular because for practical or 
legal reasons it is not reasonably possible to opt-out from that outcome;
(f) the extent to which potentially harmed or adversely impacted persons are in a 
vulnerable position in relation to the user of an AI system, in particular due to an 
imbalance of power, knowledge, economic or social circumstances, or age;
(g) the extent to which the outcome produced with an AI system is not easily reversible, 
whereby outcomes having an impact on the health or safety of persons shall not be 
considered as easily reversible;
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(h) the extent to which existing Union legislation provides for:
(i) effective measures of redress in relation to the risks posed by an AI system, 
with the exclusion of claims for damages;
(ii) effective measures to prevent or substantially minimise those risks;
(i) the magnitude and likelihood of benefit of the AI use for individuals, groups, or 
society at large.
3. The Commission is empowered to adopt delegated acts in accordance with Article 73 to 
amend the list in Annex III by removing high-risk AI systems where both of the following 
conditions are fulfilled:
(a) the high-risk AI system(s) concerned no longer pose any significant risks to 
fundamental rights, health or safety, taking into account the criteria listed in 
paragraph 2; 
(b) the deletion does not decrease the overall level of protection of health, safety and 
fundamental rights under Union law.
CHAPTER 2
REQUIREMENTS FOR HIGH-RISK AI SYSTEMS
Article 8
Compliance with the requirements
1. High-risk AI systems shall comply with the requirements established in this Chapter, 
taking into account the generally acknowledged state of the art.
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2. The intended purpose of the high-risk AI system and the risk management system referred 
to in Article 9 shall be taken into account when ensuring compliance with those 
requirements.
Article 9
Risk management system
1. A risk management system shall be established, implemented, documented and maintained 
in relation to high-risk AI systems.
2. The risk management system shall be understood as a continuous iterative process planned 
and run throughout the entire lifecycle of a high-risk AI system, requiring regular 
systematic updating. It shall comprise the following steps:
(a) identification and analysis of the known and foreseeable risks most likely to occur to 
health, safety and fundamental rights in view of the intended purpose of the high-risk 
AI system;
(b) [deleted]; 
(c) evaluation of other possibly arising risks based on the analysis of data gathered from 
the post-market monitoring system referred to in Article 61;
(d) adoption of suitable risk management measures in accordance with the provisions of 
the following paragraphs.
The risks referred to in this paragraph shall concern only those which may be reasonably 
mitigated or eliminated through the development or design of the high-risk AI system, or 
the provision of adequate technical information.
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3. The risk management measures referred to in paragraph 2, point (d) shall give due 
consideration to the effects and possible interaction resulting from the combined 
application of the requirements set out in this Chapter 2, with a view to minimising risks 
more effectively while achieving an appropriate balance in implementing the measures to 
fulfil those requirements. 
4. The risk management measures referred to in paragraph 2, point (d) shall be such that any 
residual risk associated with each hazard as well as the overall residual risk of the high-risk 
AI systems is judged acceptable.
In identifying the most appropriate risk management measures, the following shall be 
ensured:
(a) elimination or reduction of risks identified and evaluated pursuant to paragraph 2 as 
far as possible through adequate design and development of the high risk AI system;
(b) where appropriate, implementation of adequate mitigation and control measures in 
relation to risks that cannot be eliminated;
(c) provision of adequate information pursuant to Article 13, in particular as regards the 
risks referred to in paragraph 2, point (b) of this Article, and, where appropriate, 
training to users.
With a view to eliminating or reducing risks related to the use of the high-risk AI system, 
due consideration shall be given to the technical knowledge, experience, education, 
training to be expected by the user and the environment in which the system is intended to 
be used.
5. High-risk AI systems shall be tested in order to ensure that high-risk AI systems perform in 
a manner that is consistent with their intended purpose and they are in compliance with the 
requirements set out in this Chapter.
6. Testing procedures may include testing in real world conditions in accordance with Article 
54a.
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7. The testing of the high-risk AI systems shall be performed, as appropriate, at any point in 
time throughout the development process, and, in any event, prior to the placing on the 
market or the putting into service. Testing shall be made against preliminarily defined 
metrics and probabilistic thresholds that are appropriate to the intended purpose of the 
high-risk AI system.
8. The risk management system described in paragraphs 1 to 7 shall give specific 
consideration to whether the high-risk AI system is likely to be accessed by or have an 
impact on persons under the age of 18.
9. For providers of high-risk AI systems that are subject to requirements regarding internal 
risk management processes under relevant sectorial Union law, the aspects described in 
paragraphs 1 to 8 may be part of the risk management procedures established pursuant to 
that law.
Article 10
Data and data governance
1. High-risk AI systems which make use of techniques involving the training of models with 
data shall be developed on the basis of training, validation and testing data sets that meet 
the quality criteria referred to in paragraphs 2 to 5.
2. Training, validation and testing data sets shall be subject to appropriate data governance 
and management practices. Those practices shall concern in particular, 
(a) the relevant design choices;
(b) data collection processes;
(c) relevant data preparation processing operations, such as annotation, labelling, 
cleaning, enrichment and aggregation;
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(d) the formulation of relevant assumptions, notably with respect to the information that 
the data are supposed to measure and represent; 
(e) a prior assessment of the availability, quantity and suitability of the data sets that are 
needed; 
(f) examination in view of possible biases that are likely to affect health and safety of 
natural persons or lead to discrimination prohibited by Union law; 
(g) the identification of any possible data gaps or shortcomings, and how those gaps and 
shortcomings can be addressed.
3. Training, validation and testing data sets shall be relevant, representative, and to the best 
extent possible, free of errors and complete. They shall have the appropriate statistical 
properties, including, where applicable, as regards the persons or groups of persons on 
which the high-risk AI system is intended to be used. These characteristics of the data sets 
may be met at the level of individual data sets or a combination thereof.
4. Training, validation and testing data sets shall take into account, to the extent required by 
the intended purpose, the characteristics or elements that are particular to the specific 
geographical, behavioural or functional setting within which the high-risk AI system is 
intended to be used. 
5. To the extent that it is strictly necessary for the purposes of ensuring bias monitoring, 
detection and correction in relation to the high-risk AI systems, the providers of such 
systems may process special categories of personal data referred to in Article 9(1) of 
Regulation (EU) 2016/679, Article 10 of Directive (EU) 2016/680 and Article 10(1) of 
Regulation (EU) 2018/1725, subject to appropriate safeguards for the fundamental rights 
and freedoms of natural persons, including technical limitations on the re-use and use of 
state-of-the-art security and privacy-preserving measures, such as pseudonymisation, or 
encryption where anonymisation may significantly affect the purpose pursued.
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6. For the development of high-risk AI systems not using techniques involving the training of 
models, paragraphs 2 to 5 shall apply only to the testing data sets. 
Article 11
Technical documentation 
1. The technical documentation of a high-risk AI system shall be drawn up before that system 
is placed on the market or put into service and shall be kept up-to date.
The technical documentation shall be drawn up in such a way to demonstrate that the highrisk AI system complies with the requirements set out in this Chapter and provide national 
competent authorities and notified bodies with all the necessary information in a clear and 
comprehensive form to assess the compliance of the AI system with those requirements. It 
shall contain, at a minimum, the elements set out in Annex IV or, in the case of SMEs, 
including start-ups, any equivalent documentation meeting the same objectives, unless 
deemed inappropriate by the competent authority.
2. Where a high-risk AI system related to a product, to which the legal acts listed in Annex II, 
section A apply, is placed on the market or put into service one single technical 
documentation shall be drawn up containing all the information set out in Annex IV as 
well as the information required under those legal acts.
3. The Commission is empowered to adopt delegated acts in accordance with Article 73 to 
amend Annex IV where necessary to ensure that, in the light of technical progress, the 
technical documentation provides all the necessary information to assess the compliance of 
the system with the requirements set out in this Chapter.
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Article 12
Record-keeping
1. High-risk AI systems shall technically allow for the automatic recording of events (‘logs’) 
over the duration of the life cycle of the system.
2. In order to ensure a level of traceability of the AI system’s functioning that is appropriate 
to the intended purpose of the system, logging capabilities shall enable the recording of 
events relevant for 
(i) identification of situations that may result in the AI system presenting a risk within the 
meaning of Article 65(1) or in a substantial modification;
(ii) facilitation of the post-market monitoring referred to in Article 61; and
(iii) monitoring of the operation of high-risk AI systems referred to in Article 29(4).
4. For high-risk AI systems referred to in paragraph 1, point (a) of Annex III, the logging 
capabilities shall provide, at a minimum: 
(a) recording of the period of each use of the system (start date and time and end date 
and time of each use); 
(b) the reference database against which input data has been checked by the system;
(c) the input data for which the search has led to a match; 
(d) the identification of the natural persons involved in the verification of the results, as 
referred to in Article 14 (5).
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Article 13
Transparency and provision of information to users
1. High-risk AI systems shall be designed and developed in such a way to ensure that their 
operation is sufficiently transparent with a view to achieving compliance with the relevant 
obligations of the user and of the provider set out in Chapter 3 of this Title and enabling 
users to understand and use the system appropriately.
2. High-risk AI systems shall be accompanied by instructions for use in an appropriate digital 
format or otherwise that include concise, complete, correct and clear information that is 
relevant, accessible and comprehensible to users.
3. The information referred to in paragraph 2 shall specify:
(a) the identity and the contact details of the provider and, where applicable, of its 
authorised representative;
(b) the characteristics, capabilities and limitations of performance of the high-risk AI 
system, including:
(i) its intended purpose, inclusive of the specific geographical, behavioural or 
functional setting within which the high-risk AI system is intended to be used;
(ii) the level of accuracy, including its metrics, robustness and cybersecurity 
referred to in Article 15 against which the high-risk AI system has been tested 
and validated and which can be expected, and any known and foreseeable 
circumstances that may have an impact on that expected level of accuracy, 
robustness and cybersecurity;
(iii) any known or foreseeable circumstance, related to the use of the high-risk AI 
system in accordance with its intended purpose, which may lead to risks to the 
health and safety or fundamental rights referred to in Aricle 9(2);
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(iv) when appropriate, its behaviour regarding specific persons or groups of persons 
on which the system is intended to be used;
(v) when appropriate, specifications for the input data, or any other relevant 
information in terms of the training, validation and testing data sets used, 
taking into account the intended purpose of the AI system;
(vi) when appropriate, description of the expected output of the system.
(c) the changes to the high-risk AI system and its performance which have been predetermined by the provider at the moment of the initial conformity assessment, if 
any; 
(d) the human oversight measures referred to in Article 14, including the technical 
measures put in place to facilitate the interpretation of the outputs of AI systems by 
the users;
(e) the computational and hardware resources needed, the expected lifetime of the highrisk AI system and any necessary maintenance and care measures, including their 
frequency, to ensure the proper functioning of that AI system, including as regards 
software updates;
(f) a description of the mechanism included within the AI system that allows users to 
properly collect, store and interpret the logs, where relevant.
Article 14
Human oversight
1. High-risk AI systems shall be designed and developed in such a way, including with 
appropriate human-machine interface tools, that they can be effectively overseen by natural 
persons during the period in which the AI system is in use. 
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2. Human oversight shall aim at preventing or minimising the risks to health, safety or 
fundamental rights that may emerge when a high-risk AI system is used in accordance with 
its intended purpose or under conditions of reasonably foreseeable misuse, in particular 
when such risks persist notwithstanding the application of other requirements set out in this 
Chapter.
3. Human oversight shall be ensured through either one or all of the following types of 
measures:
(a) measures identified and built, when technically feasible, into the high-risk AI system 
by the provider before it is placed on the market or put into service; 
(b) measures identified by the provider before placing the high-risk AI system on the 
market or putting it into service and that are appropriate to be implemented by the 
user.
4. For the purpose of implementing paragraphs 1 to 3, the high-risk AI system shall be 
provided to the user in such a way that natural persons to whom human oversight is 
assigned are enabled, as appropriate and proportionate to the circumstances:
(a) to understand the capacities and limitations of the high-risk AI system and be able to 
duly monitor its operation;
(b) to remain aware of the possible tendency of automatically relying or over-relying on 
the output produced by a high-risk AI system (‘automation bias’);
(c) to correctly interpret the high-risk AI system’s output, taking into account for 
example the interpretation tools and methods available;
(d) to decide, in any particular situation, not to use the high-risk AI system or otherwise 
disregard, override or reverse the output of the high-risk AI system;
(e) to intervene on the operation of the high-risk AI system or interrupt the system 
through a “stop” button or a similar procedure.
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5. For high-risk AI systems referred to in point 1(a) of Annex III, the measures referred to in 
paragraph 3 shall be such as to ensure that, in addition, no action or decision is taken by the 
user on the basis of the identification resulting from the system unless this has been 
separately verified and confirmed by at least two natural persons. The requirement for a 
separate verification by at least two natural persons shall not apply to high risk AI systems 
used for the purpose of law enforcement, migration, border control or asylum, in cases 
where Union or national law considers the application of this requirement to be 
disproportionate. 
Article 15
Accuracy, robustness and cybersecurity
1. High-risk AI systems shall be designed and developed in such a way that they achieve, in 
the light of their intended purpose, an appropriate level of accuracy, robustness and 
cybersecurity, and perform consistently in those respects throughout their lifecycle.
2. The levels of accuracy and the relevant accuracy metrics of high-risk AI systems shall be 
declared in the accompanying instructions of use.
3. High-risk AI systems shall be resilient as regards errors, faults or inconsistencies that may 
occur within the system or the environment in which the system operates, in particular due 
to their interaction with natural persons or other systems.
The robustness of high-risk AI systems may be achieved through technical redundancy 
solutions, which may include backup or fail-safe plans.
High-risk AI systems that continue to learn after being placed on the market or put into 
service shall be developed in such a way to eliminate or reduce as far as possible the risk of 
possibly biased outputs influencing input for future operations (‘feedback loops’) are duly 
addressed with appropriate mitigation measures.
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4. High-risk AI systems shall be resilient as regards attempts by unauthorised third parties to 
alter their use or performance by exploiting the system vulnerabilities.
The technical solutions aimed at ensuring the cybersecurity of high-risk AI systems shall 
be appropriate to the relevant circumstances and the risks.
The technical solutions to address AI specific vulnerabilities shall include, where 
appropriate, measures to prevent and control for attacks trying to manipulate the training 
dataset (‘data poisoning’), inputs designed to cause the model to make a mistake 
(‘adversarial examples’), or model flaws.
CHAPTER 3
OBLIGATIONS OF PROVIDERS AND USERS OF HIGH-RISK AI SYSTEMS AND 
OTHER PARTIES
Article 16
Obligations of providers of high-risk AI systems 
Providers of high-risk AI systems shall:
(a) ensure that their high-risk AI systems are compliant with the requirements set out in 
Chapter 2 of this Title;
(aa) indicate their name, registered trade name or registered trade mark, the address at which 
they can be contacted on the high-risk AI system or, where that is not possible, on its 
packaging or its accompanying documentation, as applicable;
(b) have a quality management system in place which complies with Article 17;
(c) keep the documentation referred to in Article 18;
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(d) when under their control, keep the logs automatically generated by their high-risk AI 
systems as referred to in Article 20;
(e) ensure that the high-risk AI system undergoes the relevant conformity assessment 
procedure as referred to in Article 43, prior to its placing on the market or putting into 
service;
(f) comply with the registration obligations referred to in Article 51(1);
(g) take the necessary corrective actions as referred to in Article 21, if the high-risk AI system 
is not in conformity with the requirements set out in Chapter 2 of this Title;
(h) inform the relevant national competent authority of the Member States in which they made 
the AI system available or put it into service and, where applicable, the notified body of the 
non-compliance and of any corrective actions taken;
(i) to affix the CE marking to their high-risk AI systems to indicate the conformity with this 
Regulation in accordance with Article 49;
(j) upon request of a national competent authority, demonstrate the conformity of the highrisk AI system with the requirements set out in Chapter 2 of this Title.
Article 17
Quality management system 
1. Providers of high-risk AI systems shall put a quality management system in place that 
ensures compliance with this Regulation. That system shall be documented in a systematic 
and orderly manner in the form of written policies, procedures and instructions, and shall 
include at least the following aspects:
(a) a strategy for regulatory compliance, including compliance with conformity 
assessment procedures and procedures for the management of modifications to the 
high-risk AI system;
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(b) techniques, procedures and systematic actions to be used for the design, design 
control and design verification of the high-risk AI system;
(c) techniques, procedures and systematic actions to be used for the development, 
quality control and quality assurance of the high-risk AI system;
(d) examination, test and validation procedures to be carried out before, during and after 
the development of the high-risk AI system, and the frequency with which they have 
to be carried out;
(e) technical specifications, including standards, to be applied and, where the relevant 
harmonised standards are not applied in full, the means to be used to ensure that the 
high-risk AI system complies with the requirements set out in Chapter 2 of this Title;
(f) systems and procedures for data management, including data collection, data 
analysis, data labelling, data storage, data filtration, data mining, data aggregation, 
data retention and any other operation regarding the data that is performed before and 
for the purposes of the placing on the market or putting into service of high-risk AI 
systems;
(g) the risk management system referred to in Article 9;
(h) the setting-up, implementation and maintenance of a post-market monitoring system, 
in accordance with Article 61;
(i) procedures related to the reporting of a serious incident in accordance with Article 
62;
(j) the handling of communication with national competent authorities, competent 
authorities, including sectoral ones, providing or supporting the access to data, 
notified bodies, other operators, customers or other interested parties;
(k) systems and procedures for record keeping of all relevant documentation and 
information;
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(l) resource management, including security of supply related measures;
(m) an accountability framework setting out the responsibilities of the management and 
other staff with regard to all aspects listed in this paragraph.
2. The implementation of aspects referred to in paragraph 1 shall be proportionate to the size 
of the provider’s organisation. 
2a. For providers of high-risk AI systems that are subject to obligations regarding quality 
management systems under relevant sectorial Union law, the aspects described in 
paragraph 1 may be part of the quality management systems pursuant to that law.
3. For providers that are financial institutions subject to requirements regarding their internal 
governance, arrangements or processes under Union financial services legislation, the 
obligation to put in place a quality management system with the exception of paragraph 1, 
points (g), (h) and (i) shall be deemed to be fulfilled by complying with the rules on 
internal governance arrangements or processes pursuant to the relevant Union financial 
services legislation. In that context, any harmonised standards referred to in Article 40 of 
this Regulation shall be taken into account.
Article 18
Documentation keeping
1. The provider shall, for a period ending 10 years after the AI system has been placed on the 
market or put into service, keep at the disposal of the national competent authorities:
(a) the technical documentation referred to in Article 11; 
(b) the documentation concerning the quality management system referred to in 
Article 17;
(c) the documentation concerning the changes approved by notified bodies where 
applicable; 
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(d) the decisions and other documents issued by the notified bodies where applicable; 
(e) the EU declaration of conformity referred to in Article 48.
1a. Each Member State shall determine conditions under which the documentation referred to 
in paragraph 1 remains at the disposal of the national competent authorities for the period 
indicated in that paragraph for the cases when a provider or its authorised representative 
established on its territory goes bankrupt or ceases its activity prior to the end of that 
period.
2. Providers that are financial institutions subject to requirements regarding their internal 
governance, arrangements or processes under Union financial services legislation shall 
maintain the technical documentation as part of the documentation kept under the relevant 
Union financial services legislation.
Article 19
Conformity assessment 
1. Providers of high-risk AI systems shall ensure that their systems undergo the relevant 
conformity assessment procedure in accordance with Article 43, prior to their placing on 
the market or putting into service. Where the compliance of the AI systems with the 
requirements set out in Chapter 2 of this Title has been demonstrated following that 
conformity assessment, the providers shall draw up an EU declaration of conformity in 
accordance with Article 48 and affix the CE marking of conformity in accordance with 
Article 49. 
2. [deleted]
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Article 20
Automatically generated logs
1. Providers of high-risk AI systems shall keep the logs, referred to in Article 12(1), 
automatically generated by their high-risk AI systems, to the extent such logs are under 
their control by virtue of a contractual arrangement with the user or otherwise by law. They 
shall keep them for a period of at least six months, unless provided otherwise in applicable
Union or national law, in particular in Union law on the protection of personal data.
2. Providers that are financial institutions subject to requirements regarding their internal 
governance, arrangements or processes under Union financial services legislation shall 
maintain the logs automatically generated by their high-risk AI systems as part of the 
documentation kept under the relevant financial service legislation.
Article 21
Corrective actions
Providers of high-risk AI systems which consider or have reason to consider that a high-risk AI 
system which they have placed on the market or put into service is not in conformity with this 
Regulation shall immediately investigate, where applicable, the causes in collaboration with the 
reporting user and take the necessary corrective actions to bring that system into conformity, to 
withdraw it or to recall it, as appropriate. They shall inform the distributors of the high-risk AI 
system in question and, where applicable, the authorised representative and importers accordingly.
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Article 22
Duty of information
Where the high-risk AI system presents a risk within the meaning of Article 65(1) and that risk is 
known to the provider of the system, that provider shall immediately inform the national competent 
authorities of the Member States in which it made the system available and, where applicable, the 
notified body that issued a certificate for the high-risk AI system, in particular of the noncompliance and of any corrective actions taken.
Article 23
Cooperation with competent authorities
Providers of high-risk AI systems shall, upon request by a national competent authority, provide 
that authority with all the information and documentation necessary to demonstrate the conformity 
of the high-risk AI system with the requirements set out in Chapter 2 of this Title, in a language 
which can be easily understood by the authority of the Member State concerned. Upon a reasoned 
request from a national competent authority, providers shall also give that authority access to the 
logs, referred to in Article 12(1), automatically generated by the high-risk AI system, to the extent 
such logs are under their control by virtue of a contractual arrangement with the user or otherwise 
by law.
Article 23a
Conditions for other persons to be subject to the obligations of a provider 
1. Any natural or legal person shall be considered a provider of a new high-risk AI system for 
the purposes of this Regulation and shall be subject to the obligations of the provider under 
Article 16, in any of the following circumstances:
(a) they put their name or trademark on a high-risk AI system already placed on the 
market or put into service, without prejudice to contractual arrangements stipulating 
that the obligations are allocated otherwise;
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(b) [deleted]
(c) they make a substantial modification to a high-risk AI system already placed on the 
market or put into service;
(d) they modify the intended purpose of an AI system which is not high-risk and is 
already placed on the market or put ito service, in a way which makes the modified 
system a high-risk AI system;
(e) they place on the market or put into service a general purpose AI system as a highrisk AI system or as a component of a high-risk AI system.
2. Where the circumstances referred to in paragraph 1, point (a) or (c), occur, the provider that 
initially placed the high-risk AI system on the market or put it into service shall no longer be 
considered a provider for the purposes of this Regulation.
3. For high-risk AI systems that are safety components of products to which the legal acts listed 
in Annex II, section A apply, the manufacturer of those products shall be considered the 
provider of the high-risk AI system and shall be subject to the obligations under Article 16 
under either of the following scenarios:
(i) the high-risk AI system is placed on the market together with the product under the 
name or trademark of the product manufacturer; 
(ii) the high-risk AI system is put into service under the the name or trademark of the 
product manufacturer after the product has been placed on the market.
Article 24
[deleted]
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Article 25
Authorised representatives
1. Prior to making their systems available on the Union market providers established outside 
the Union shall, by written mandate, appoint an authorised representative which is 
established in the Union.
2. The authorised representative shall perform the tasks specified in the mandate received 
from the provider. For the purpose of this Regulation, the mandate shall empower the 
authorised representative to carry out only the following tasks:
(-a) verify that the EU declaration of conformity and the technical documentation have 
been drawn up and that an appropriate conformity assessment procedure has 
been carried out by the provider;
(a) keep at the disposal of the national competent authorities and national authorities 
referred to in Article 63(7), for a period ending 10 years after the high-risk AI system 
has been placed on the market or put into service, the contact details of the provider 
by which the authorised representative has been appointed, a copy of the EU 
declaration of conformity, the technical documentation and, if applicable, the 
certificate issued by the notified body;
(b) provide a national competent authority, upon a reasoned request, with all the 
information and documentation, including that kept according to point (b), necessary 
to demonstrate the conformity of a high-risk AI system with the requirements set out 
in Chapter 2 of this Title, including access to the logs, referred to in Article 12(1), 
automatically generated by the high-risk AI system to the extent such logs are under 
the control of the provider by virtue of a contractual arrangement with the user or 
otherwise by law;
(c) cooperate with national competent authorities, upon a reasoned request, on any 
action the latter takes in relation to the high-risk AI system.
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(d) comply with the registration obligations referred to in Article 51(1) and, if the 
registration of the system is carried out by the provider itself, verify that the 
information referred to in Annex VIII, Part II, 1 to 11, is correct.
The authorised representative shall terminate the mandate if it has sufficient reasons to consider that 
the provider acts contrary to its obligations under this Regulation. In such a case, it shall also 
immediately inform the market surveillance authority of the Member State in which it is 
established, as well as, where applicable, the relevant notified body, about the termination of the 
mandate and the reasons thereof.
The authorised representative shall be legally liable for defective AI systems on the same basis as, 
and jointly and severally with, the provider in respect of its potential liability under Council 
Directive 85/374/EEC.
Article 26
Obligations of importers
1. Before placing a high-risk AI system on the market, importers of such system shall ensure 
that such a system is in conformity with this Regulation by verifying that:
(a) the relevant conformity assessment procedure referred to in Article 43 has been 
carried out by the provider of that AI system; 
(b) the provider has drawn up the technical documentation in accordance with Annex 
IV; 
(c) the system bears the required CE conformity marking and is accompanied by the EU 
declaration of conformity and instructions of use; 
(d) the authorised representative referred to in Article 25 has been established by the 
provider.
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2. Where an importer has sufficient reasons to consider that a high-risk AI system is not in 
conformity with this Regulation, or is falsified, or accompanied by falsified 
documentation, it shall not place that system on the market until that AI system has been 
brought into conformity. Where the high-risk AI system presents a risk within the meaning 
of Article 65(1), the importer shall inform the provider of the AI system, the authorised 
representatives and the market surveillance authorities to that effect.
3. Importers shall indicate their name, registered trade name or registered trade mark, and the 
address at which they can be contacted on the high-risk AI system or, where that is not 
possible, on its packaging or its accompanying documentation, as applicable.
4. Importers shall ensure that, while a high-risk AI system is under their responsibility, where 
applicable, storage or transport conditions do not jeopardise its compliance with the 
requirements set out in Chapter 2 of this Title.
4a. Importers shall keep, for a period ending 10 years after the AI system has been placed on 
the market or put into service, a copy of the certificate issued by the notified body, where 
applicable, of the instructions for use and of the EU declaration of conformity.
5. Importers shall provide national competent authorities, upon a reasoned request, with all 
necessary information and documentation, including that kept in accordance with 
paragraph 5, to demonstrate the conformity of a high-risk AI system with the requirements 
set out in Chapter 2 of this Title in a language which can be easily understood by that 
national competent authority. To this purpose they shall also ensure that the technical 
documentation can be made available to those authorities. 
5a. Importers shall cooperate with national competent authorities on any action those 
authorities take in relation to an AI system, of which they are the importer.
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Article 27
Obligations of distributors
1. Before making a high-risk AI system available on the market, distributors shall verify that 
the high-risk AI system bears the required CE conformity marking, that it is accompanied 
by a copy of EU declaration of conformity and instruction of use, and that the provider and 
the importer of the system, as applicable, have complied with their obligations set out 
Article 16, point (b) and 26(3) respectively.
2. Where a distributor considers or has reason to consider that a high-risk AI system is not in 
conformity with the requirements set out in Chapter 2 of this Title, it shall not make the 
high-risk AI system available on the market until that system has been brought into 
conformity with those requirements. Furthermore, where the system presents a risk within 
the meaning of Article 65(1), the distributor shall inform the provider or the importer of the 
system, as applicable, to that effect.
3. Distributors shall ensure that, while a high-risk AI system is under their responsibility, 
where applicable, storage or transport conditions do not jeopardise the compliance of the 
system with the requirements set out in Chapter 2 of this Title.
4. A distributor that considers or has reason to consider that a high-risk AI system which it 
has made available on the market is not in conformity with the requirements set out in 
Chapter 2 of this Title shall take the corrective actions necessary to bring that system into 
conformity with those requirements, to withdraw it or recall it or shall ensure that the 
provider, the importer or any relevant operator, as appropriate, takes those corrective 
actions. Where the high-risk AI system presents a risk within the meaning of Article 65(1), 
the distributor shall immediately inform the national competent authorities of the Member 
States in which it has made the product available to that effect, giving details, in particular, 
of the non-compliance and of any corrective actions taken.
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5. Upon a reasoned request from a national competent authority, distributors of high-risk AI 
systems shall provide that authority with all the information and documentation regarding 
its activities as described in paragraph 1 to 4.
5a. Distributors shall cooperate with national competent authorities on any action those 
authorities take in relation to an AI system, of which they are the distributor.
Article 28
[deleted]
Article 29
Obligations of users of high-risk AI systems
1. Users of high-risk AI systems shall use such systems in accordance with the instructions of 
use accompanying the systems, pursuant to paragraphs 2 and 5 of this Article. 
1a. Users shall assign human oversight to natural persons who have the necessary competence, 
training and authority.
2. The obligations in paragraph 1 and 1a are without prejudice to other user obligations under 
Union or national law and to the user’s discretion in organising its own resources and 
activities for the purpose of implementing the human oversight measures indicated by the 
provider.
3. Without prejudice to paragraph 1, to the extent the user exercises control over the input 
data, that user shall ensure that input data is relevant in view of the intended purpose of the 
high-risk AI system. 
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4. Users shall implement human oversight and monitor the operation of the high-risk AI 
system on the basis of the instructions of use. When they have reasons to consider that the 
use in accordance with the instructions of use may result in the AI system presenting a risk 
within the meaning of Article 65(1) they shall inform the provider or distributor and 
suspend the use of the system. They shall also inform the provider or distributor when they 
have identified any serious incident and interrupt the use of the AI system. In case the user 
is not able to reach the provider, Article 62 shall apply mutatis mutandis. This obligation 
shall not cover sensitive operational data of users of AI systems which are law enforcement 
authorities.
For users that are financial institutions subject to requirements regarding their internal 
governance, arrangements or processes under Union financial services legislation, the 
monitoring obligation set out in the first subparagraph shall be deemed to be fulfilled by 
complying with the rules on internal governance arrangements, processes and mechanisms 
pursuant to the relevant financial service legislation.
5. Users of high-risk AI systems shall keep the logs, referred to in Article 12(1), 
automatically generated by that high-risk AI system, to the extent such logs are under their 
control. They shall keep them for a period of at least six months, unless provided otherwise 
in applicable Union or national law, in particular in Union law on the protection of 
personal data.
Users that are financial institutions subject to requirements regarding their internal 
governance, arrangements or processes under Union financial services legislation shall 
maintain the logs as part of the documentation kept pursuant to the relevant Union 
financial service legislation.
5a. Users of high-risk AI systems that are public authorities, agencies or bodies, with the 
exception of law enforcement, border control, immigration or asylum authorities, shall 
comply with the registration obligations referred to in Article 51. When they find that the 
system that they envisage to use has not been registered in the EU database referred to in 
Article 60 they shall not use that system and shall inform the provider or the distributor.
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6. Users of high-risk AI systems shall use the information provided under Article 13 to 
comply with their obligation to carry out a data protection impact assessment under Article 
35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680, where 
applicable.
6a. Users shall cooperate with national competent authorities on any action those authorities 
take in relation to an AI system, of which they are the user.
CHAPTER 4
NOTIFIYING AUTHORITIES AND NOTIFIED BODIES
Article 30
Notifying authorities
1. Each Member State shall designate or establish at least one notifying authority responsible 
for setting up and carrying out the necessary procedures for the assessment, designation 
and notification of conformity assessment bodies and for their monitoring. 
2. Member States may decide that the assessment and monitoring referred to in paragraph 1 
shall be carried out by a national accreditation body within the meaning of and in 
accordance with Regulation (EC) No 765/2008.
3. Notifying authorities shall be established, organised and operated in such a way that no 
conflict of interest arises with conformity assessment bodies and the objectivity and 
impartiality of their activities are safeguarded.
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4. Notifying authorities shall be organised in such a way that decisions relating to the 
notification of conformity assessment bodies are taken by competent persons different 
from those who carried out the assessment of those bodies.
5. Notifying authorities shall not offer or provide any activities that conformity assessment 
bodies perform or any consultancy services on a commercial or competitive basis.
6. Notifying authorities shall safeguard the confidentiality of the information they obtain in 
accordance with Article 70.
7. Notifying authorities shall have an adequate number of competent personnel at their 
disposal for the proper performance of their tasks.
8. [deleted]
Article 31
Application of a conformity assessment body for notification 
1. Conformity assessment bodies shall submit an application for notification to the notifying 
authority of the Member State in which they are established.
2. The application for notification shall be accompanied by a description of the conformity 
assessment activities, the conformity assessment module or modules and the AI systems
for which the conformity assessment body claims to be competent, as well as by an 
accreditation certificate, where one exists, issued by a national accreditation body attesting 
that the conformity assessment body fulfils the requirements laid down in Article 33. Any 
valid document related to existing designations of the applicant notified body under any 
other Union harmonisation legislation shall be added. 
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3. Where the conformity assessment body concerned cannot provide an accreditation 
certificate, it shall provide the notifying authority with all the documentary evidence 
necessary for the verification, recognition and regular monitoring of its compliance with 
the requirements laid down in Article 33. For notified bodies which are designated under 
any other Union harmonisation legislation, all documents and certificates linked to those 
designations may be used to support their designation procedure under this Regulation, as 
appropriate. The notified body shall update the documentation referred to in paragraph 2 
and paragraph 3 whenever relevant changes occur, in order to enable the authority 
responsible for notified bodies to monitor and verify continuous compliance with all the 
requirements laid down in Article 33.
Article 32
Notification procedure
1. Notifying authorities may only notify conformity assessment bodies which have satisfied 
the requirements laid down in Article 33. 
2. Notifying authorities shall notify those bodies to the Commission and the other Member 
States using the electronic notification tool developed and managed by the Commission. 
3. The notification referred to in paragraph 2 shall include full details of the conformity 
assessment activities, the conformity assessment module or modules and the AI systems 
concerned and the relevant attestation of competence. Where a notification is not based on 
an accreditation certificate as referred to in Article 31 (2), the notifying authority shall 
provide the Commission and the other Member States with documentary evidence which 
attests to the conformity assessment body's competence and the arrangements in place to 
ensure that that body will be monitored regularly and will continue to satisfy the 
requirements laid down in Article 33. 
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4. The conformity assessment body concerned may perform the activities of a notified body 
only where no objections are raised by the Commission or the other Member States within 
two weeks of a notification by a notifying authority where it includes an accreditation 
certificate referred to in Article 31(2), or within two months of a notification by the 
notifying authority where it includes documentary evidence referred to in Article 31(3). 
5. [deleted]
Article 33
Requirements relating to notified bodies 
1. A notified body shall be established under national law and have legal personality.
2. Notified bodies shall satisfy the organisational, quality management, resources and process 
requirements that are necessary to fulfil their tasks.
3. The organisational structure, allocation of responsibilities, reporting lines and operation of 
notified bodies shall be such as to ensure that there is confidence in the performance by 
and in the results of the conformity assessment activities that the notified bodies conduct.
4. Notified bodies shall be independent of the provider of a high-risk AI system in relation to 
which it performs conformity assessment activities. Notified bodies shall also be 
independent of any other operator having an economic interest in the high-risk AI system 
that is assessed, as well as of any competitors of the provider.
5. Notified bodies shall be organised and operated so as to safeguard the independence, 
objectivity and impartiality of their activities. Notified bodies shall document and 
implement a structure and procedures to safeguard impartiality and to promote and apply 
the principles of impartiality throughout their organisation, personnel and assessment 
activities. 
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6. Notified bodies shall have documented procedures in place ensuring that their personnel, 
committees, subsidiaries, subcontractors and any associated body or personnel of external 
bodies respect the confidentiality of the information in accordance with Article 70 which 
comes into their possession during the performance of conformity assessment activities, 
except when disclosure is required by law. The staff of notified bodies shall be bound to 
observe professional secrecy with regard to all information obtained in carrying out their 
tasks under this Regulation, except in relation to the notifying authorities of the Member 
State in which their activities are carried out. 
7. Notified bodies shall have procedures for the performance of activities which take due 
account of the size of an undertaking, the sector in which it operates, its structure, the 
degree of complexity of the AI system in question.
8. Notified bodies shall take out appropriate liability insurance for their conformity 
assessment activities, unless liability is assumed by the Member State in which they are 
located in accordance with national law or that Member State is itself directly responsible 
for the conformity assessment.
9. Notified bodies shall be capable of carrying out all the tasks falling to them under this 
Regulation with the highest degree of professional integrity and the requisite competence 
in the specific field, whether those tasks are carried out by notified bodies themselves or on 
their behalf and under their responsibility.
10. Notified bodies shall have sufficient internal competences to be able to effectively evaluate 
the tasks conducted by external parties on their behalf. The notified body shall have 
permanent availability of sufficient administrative, technical, legal and scientific personnel 
who possess experience and knowledge relating to the relevant artificial intelligence 
technologies, data and data computing and to the requirements set out in Chapter 2 of this 
Title.
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11. Notified bodies shall participate in coordination activities as referred to in Article 38. They 
shall also take part directly or be represented in European standardisation organisations, or 
ensure that they are aware and up to date in respect of relevant standards.
12. [deleted]
Article 33a
Presumption of conformity with requirements relating to notified bodies 
Where a conformity assessment body demonstrates its conformity with the criteria laid down in the 
relevant harmonised standards or parts thereof the references of which have been published in the 
Official Journal of the European Union it shall be presumed to comply with the requirements set out 
in Article 33 in so far as the applicable harmonised standards cover those requirements.
Article 34
Subsidiaries of and subcontracting by notified bodies
1. Where a notified body subcontracts specific tasks connected with the conformity 
assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the 
subsidiary meets the requirements laid down in Article 33 and shall inform the notifying 
authority accordingly. 
2. Notified bodies shall take full responsibility for the tasks performed by subcontractors or 
subsidiaries wherever these are established.
3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of 
the provider.
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4. The relevant documents concerning the assessment of the qualifications of the 
subcontractor or the subsidiary and the work carried out by them under this Regulation 
shall be kept at the disposal of the notifying authority for a period of 5 years from the 
termination date of the subcontracting activity.
Article 34a
Operational obligations of notified bodies
1. Notified bodies shall verify the conformity of high-risk AI system in accordance with the 
conformity assessment procedures referred to in Article 43. 
2. Notified bodies shall perform their activities while avoiding unnecessary burdens for 
providers, and taking due account of the size of an undertaking, the sector in which it 
operates, its structure and the degree of complexity of the high risk AI system in question. 
In so doing, the notified body shall nevertheless respect the degree of rigour and the level 
of protection required for the compliance of the high risk AI system with the requirements 
of this Regulation.
3. Notified bodies shall make available and submit upon request all relevant documentation, 
including the providers’ documentation, to the notifying authority referred to in Article 30 
to allow that authority to conduct its assessment, designation, notification, monitoring 
activities and to facilitate the assessment outlined in this Chapter.
Article 35
Identification numbers and lists of notified bodies designated under this Regulation
1. The Commission shall assign an identification number to notified bodies. It shall assign a 
single number, even where a body is notified under several Union acts.
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2. The Commission shall make publicly available the list of the bodies notified under this 
Regulation, including the identification numbers that have been assigned to them and the 
activities for which they have been notified. The Commission shall ensure that the list is 
kept up to date.
Article 36
Changes to notifications
1. The notifying authority shall notify the Commission and the other Member States of any 
relevant changes to the notification of a notified body via the electronic notification tool 
referred to in Article 32(2). 
2. The procedures described in Article 31 and 32 shall apply to extensions of the scope of the 
notification. For changes to the notification other than extensions of its scope, the 
procedures laid down in the following paragraphs shall apply. 
Where a notified body decides to cease its conformity assessment activities it shall inform 
the notifying authority and the providers concerned as soon as possible and in the case of a 
planned cessation one year before ceasing its activities. The certificates may remain valid 
for a temporary period of nine months after cessation of the notified body's activities on 
condition that another notified body has confirmed in writing that it will assume 
responsibilities for the AI systems covered by those certificates. The new notified body 
shall complete a full assessment of the AI systems affected by the end of that period before 
issuing new certificates for those systems. Where the notified body has ceased its activity, 
the notifying authority shall withdraw the designation.
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3. Where a notifying authority has sufficient reasons to consider that a notified body no 
longer meets the requirements laid down in Article 33, or that it is failing to fulfil its 
obligations, the notifying authority shall, provided that the the notified body had the 
opportunity to make its views known, restrict, suspend or withdraw notification as 
appropriate, depending on the seriousness of the failure to meet those requirements or fulfil 
those obligations. It shall immediately inform the Commission and the other Member 
States accordingly.
4. Where its designation has been suspended, restricted, or fully or partially withdrawn, the 
notified body shall inform the manufacturers concerned at the latest within 10 days. 
5. In the event of restriction, suspension or withdrawal of a notification, the notifying 
authority shall take appropriate steps to ensure that the files of the notified body concerned 
are kept and make them available to notifying authorities in other Member States and to 
market surveillance authorities at their request. 
6. In the event of restriction, suspension or withdrawal of a designation, the notifying 
authority shall: 
a) assess the impact on the certificates issued by the notified body; 
b) submit a report on its findings to the Commission and the other Member States 
within three months of having notified the changes to the notification;
c) require the notified body to suspend or withdraw, within a reasonable period of time 
determined by the authority, any certificates which were unduly issued in order to
ensure the conformity of AI systems on the market; 
d) inform the Commission and the Member States about certificates of which it has 
required their suspension or withdrawal;
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e) provide the national competent authorities of the Member State in which the provider 
has its registered place of business with all relevant information about the certificates 
for which it has required suspension or withdrawal. That competent authority shall 
take the appropriate measures, where necessary, to avoid a potential risk to health, 
safety or fundamental rights.
7. With the exception of certificates unduly issued, and where a notification has been 
suspended or restricted, the certificates shall remain valid in the following circumstances: 
a) the notifying authority has confirmed, within one month of the suspension or 
restriction, that there is no risk to health, safety or fundamental rights in relation to
certificates affected by the suspension or restriction, and the notifying authority has 
outlined a timeline and actions anticipated to remedy the suspension or restriction; or 
b) the notifying authority has confirmed that no certificates relevant to the suspension 
will be issued, amended or re-issued during the course of the suspension or 
restriction, and states whether the notified body has the capability of continuing to 
monitor and remain responsible for existing certificates issued for the period of the 
suspension or restriction. In the event that the authority responsible for notified 
bodies determines that the notified body does not have the capability to support 
existing certificates issued, the provider shall provide to the national competent 
authorities of the Member State in which the provider of the system covered by the 
certificate has its registered place of business, within three months of the suspension 
or restriction, a written confirmation that another qualified notified body is 
temporarily assuming the functions of the notified body to monitor and remain 
responsible for the certificates during the period of suspension or restriction. 
8. With the exception of certificates unduly issued, and where a designation has been 
withdrawn, the certificates shall remain valid for a period of nine months in the following 
circumstances: 
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a) where the national competent authority of the Member State in which the provider of 
the AI system covered by the certificate has its registered place of business has 
confirmed that there is no risk to health, safety and fundamental rights associated 
with the systems in question; and 
b) another notified body has confirmed in writing that it will assume immediate 
responsibilities for those systems and will have completed assessment of them within 
twelve months of the withdrawal of the designation.
In the circumstances referred to in the first subparagraph, the national competent authority 
of the Member State in which the provider of the system covered by the certificate has its 
place of business may extend the provisional validity of the certificates for further periods 
of three months, which altogether shall not exceed twelve months. 
The national competent authority or the notified body assuming the functions of the 
notified body affected by the change of notification shall immediately inform the 
Commission, the other Member States and the other notified bodies thereof.
Article 37
Challenge to the competence of notified bodies
1. The Commission shall, where necessary, investigate all cases where there are reasons to 
doubt whether a notified body complies with the requirements laid down in Article 33.
2. The notifying authority shall provide the Commission, on request, with all relevant 
information relating to the notification of the notified body concerned.
3. The Commission shall ensure that all confidential information obtained in the course of its 
investigations pursuant to this Article is treated confidentially in accordance with Article 
70.
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4. Where the Commission ascertains that a notified body does not meet or no longer meets 
the requirements laid down in Article 33, it shall inform the notifying authority of the 
reasons of such an ascertainment and request it to take the necessary corrective measures, 
including the suspension, restriction or withdrawal of the designation if necessary. Where 
the notifying authority fails to take the necessary corrective measures, the Commission 
may, by means of implementing acts, suspend, restrict or withdraw the notification. That 
implementing act shall be adopted in accordance with the examination procedure referred 
to in Article 74(2). 
Article 38
Coordination of notified bodies
1. The Commission shall ensure that, with regard to high-risk AI systems, appropriate 
coordination and cooperation between notified bodies active in the conformity assessment 
procedures pursuant to this Regulation are put in place and properly operated in the form 
of a sectoral group of notified bodies.
2. The notifying authority shall ensure that the bodies notified by them participate in the work 
of that group, directly or by means of designated representatives.
Article 39
Conformity assessment bodies of third countries
Conformity assessment bodies established under the law of a third country with which the Union 
has concluded an agreement may be authorised to carry out the activities of notified Bodies under 
this Regulation, provided that they meet the requirements in Article 33.
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CHAPTER 5
STANDARDS, CONFORMITY ASSESSMENT, CERTIFICATES, REGISTRATION
Article 40
Harmonised standards
1. High-risk AI systems or general purpose AI systems which are in conformity with harmonised 
standards or parts thereof the references of which have been published in the Official Journal 
of the European Union shall be presumed to be in conformity with the requirements set out in 
Chapter 2 of this Title or, as applicable, with requirements set out in Article 4a and Article 4b, 
to the extent those standards cover those requirements.
2. When issuing a standardisation request to European standardisation organisations in
accordance with Article 10 of Regulation 1025/2012, the Commission shall specify that 
standards are coherent, clear and drafted in such a way that they aim to fulfil in particular the 
following objectives:
a) ensure that AI systems placed on the market or put into service in the Union are safe 
and respect Union values and strengthen the Union's open strategic autonomy;
b) promote investment and innovation in AI, including through increasing legal certainty, as 
well as competitiveness and growth of the Union market;
c) enhance multistakeholder governance, representative of all relevant European 
stakeholders (e.g. industry, SMEs, civil society, researchers);
d) contribute to strengthening global cooperation on standardisation in the field of AI that 
is consistent with Union values and interests.
The Commission shall request the European standardisation organisations to provide 
evidence of their best efforts to fulfil the above objectives.
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Article 41
Common specifications
1. The Commission is empowered to adopt, after consulting the AI Board referred to in 
Article 56, implementing acts in accordance with the examination procedure referred to in 
Article 74(2) establishing common technical specifications for the requirements set out in 
Chapter 2 of this Title, or, as applicable, with requirements set out in Article 4a and Article 
4b, where the following conditions have been fulfilled: 
(a) no reference to harmonised standards covering the relevant essential safety or 
fundamental right concerns is published in the Official Journal of the European Union 
in accordance with Regulation (EU) No 1025/2012;
(b) the Commission has requested, pursuant to Article 10(1) of Regulation 1025/2012, one 
or more European standardisation organisations to draft a harmonised standard for the 
requirements set out in Chapter 2 of this Title;
(c) the request referred to in point (b) has not been accepted by any of the European 
standardisation organisations or the harmonised standards addressing that request are 
not delivered within the deadline set in accordance with article 10(1) of Regulation 
1025/2012 or those standards do not comply with the request.
1a. Before preparing a draft implementing act, the Commission shall inform the committee 
referred to in Article 22 of Regulation EU (No) 1025/2012 that it considers that the 
conditions in paragraph 1 are fulfilled.
2. In the early preparation of the draft implementing act establishing the common 
specification, the Commission shall fulfil the objectives referred to in Article 40(2) and 
gather the views of relevant bodies or expert groups established under relevant sectorial 
Union law. Based on that consultation, the Commission shall prepare the draft 
implementing act.
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3. High-risk AI systems or general purpose AI systems which are in conformity with the 
common specifications referred to in paragraph 1 shall be presumed to be in conformity 
with the requirements set out in Chapter 2 of this Title or, as applicable, with requirements 
set out in Article 4a and Article 4b, to the extent those common specifications cover those 
requirements.
4. When references of a harmonised standard are published in the Official Journal of the 
European Union, implementing acts referred to in paragraph 1, which cover the 
requirements set out in Chapter 2 of this Title or requirements set out in Article 4a and 
Article 4b, shall be repealed, as applicable.
5. When a Member State considers that a common specification does not entirely satisfy the 
requirements set out in Chapter 2 of this Title or requirements set out in Article 4a and 
Article 4b, as applicable, it shall inform the Commission thereof with a detailed 
explanation and the Commission shall assess that information and, if appropriate, amend 
the implementing act establishing the common specification in question.
Article 42
Presumption of conformity with certain requirements
1. High-risk AI systems that have been trained and tested on data reflecting the specific 
geographical, behavioural or functional setting within which they are intended to be used 
shall be presumed to be in compliance with the respective requirements set out in Article 
10(4). 
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2. High-risk AI systems or general purpose AI systems that have been certified or for which a 
statement of conformity has been issued under a cybersecurity scheme pursuant to 
Regulation (EU) 2019/881 of the European Parliament and of the Council33 and the 
references of which have been published in the Official Journal of the European Union 
shall be presumed to be in compliance with the cybersecurity requirements set out in 
Article 15 of this Regulation in so far as the cybersecurity certificate or statement of 
conformity or parts thereof cover those requirements.
Article 43
Conformity assessment
1. For high-risk AI systems listed in point 1 of Annex III, where, in demonstrating the 
compliance of a high-risk AI system with the requirements set out in Chapter 2 of this 
Title, the provider has applied harmonised standards referred to in Article 40, or, where 
applicable, common specifications referred to in Article 41, the provider shall opt for one 
of the following procedures:
(a) the conformity assessment procedure based on internal control referred to in Annex 
VI; or
(b) the conformity assessment procedure based on assessment of the quality 
management system and assessment of the technical documentation, with the 
involvement of a notified body, referred to in Annex VII.
Where, in demonstrating the compliance of a high-risk AI system with the requirements set 
out in Chapter 2 of this Title, the provider has not applied or has applied only in part 
harmonised standards referred to in Article 40, or where such harmonised standards do not 
exist and common specifications referred to in Article 41 are not available, the provider 
shall follow the conformity assessment procedure set out in Annex VII.
 
33 Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the 
European Union Agency for Cybersecurity) and on information and communications technology cybersecurity 
certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 7.6.2019, p. 1).
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For the purpose of the conformity assessment procedure referred to in Annex VII, the 
provider may choose any of the notified bodies. However, when the system is intended to 
be put into service by law enforcement, immigration or asylum authorities as well as EU 
institutions, bodies or agencies, the market surveillance authority referred to in Article 
63(5) or (6), as applicable, shall act as a notified body.
2. For high-risk AI systems referred to in points 2 to 8 of Annex III and for general purpose 
AI systems referred in Title 1a, providers shall follow the conformity assessment 
procedure based on internal control as referred to in Annex VI, which does not provide for 
the involvement of a notified body. 
3. For high-risk AI systems, to which legal acts listed in Annex II, section A, apply, the 
provider shall follow the relevant conformity assessment as required under those legal acts. 
The requirements set out in Chapter 2 of this Title shall apply to those high-risk AI systems 
and shall be part of that assessment. Points 4.3., 4.4., 4.5. and the fifth paragraph of point 
4.6 of Annex VII shall also apply. 
For the purpose of that assessment, notified bodies which have been notified under those 
legal acts shall be entitled to control the conformity of the high-risk AI systems with the 
requirements set out in Chapter 2 of this Title, provided that the compliance of those 
notified bodies with requirements laid down in Article 33(4), (9) and (10) has been 
assessed in the context of the notification procedure under those legal acts.
Where the legal acts listed in Annex II, section A, enable the manufacturer of the product 
to opt out from a third-party conformity assessment, provided that that manufacturer has 
applied all harmonised standards covering all the relevant requirements, that manufacturer 
may make use of that option only if he has also applied harmonised standards or, where 
applicable, common specifications referred to in Article 41, covering the requirements set 
out in Chapter 2 of this Title. 
4. [deleted]
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5. The Commission is empowered to adopt delegated acts in accordance with Article 73 for 
the purpose of updating Annexes VI and Annex VII in light of technical progress.
6. The Commission is empowered to adopt delegated acts to amend paragraphs 1 and 2 in 
order to subject high-risk AI systems referred to in points 2 to 8 of Annex III to the 
conformity assessment procedure referred to in Annex VII or parts thereof. The 
Commission shall adopt such delegated acts taking into account the effectiveness of the 
conformity assessment procedure based on internal control referred to in Annex VI in 
preventing or minimizing the risks to health and safety and protection of fundamental 
rights posed by such systems as well as the availability of adequate capacities and 
resources among notified bodies.
Article 44
Certificates
1. Certificates issued by notified bodies in accordance with Annex VII shall be drawn-up in a 
a language which can be easily undestood by the relevant authorities in the Member State 
in which the notified body is established. 
2. Certificates shall be valid for the period they indicate, which shall not exceed five years. 
On application by the provider, the validity of a certificate may be extended for further 
periods, each not exceeding five years, based on a re-assessment in accordance with the 
applicable conformity assessment procedures. Any supplement to a certificate shall remain 
valid as long as the certificate which it supplements is valid.
3. Where a notified body finds that an AI system no longer meets the requirements set out in 
Chapter 2 of this Title, it shall, taking account of the principle of proportionality, suspend 
or withdraw the certificate issued or impose any restrictions on it, unless compliance with 
those requirements is ensured by appropriate corrective action taken by the provider of the 
system within an appropriate deadline set by the notified body. The notified body shall 
give reasons for its decision.
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Article 45
Appeal against decisions of notified bodies
An appeal procedure against decisions of the notified bodies shall be available.
Article 46
Information obligations of notified bodies
1. Notified bodies shall inform the notifying authority of the following: 
(a) any Union technical documentation assessment certificates, any supplements to those 
certificates, quality management system approvals issued in accordance with the 
requirements of Annex VII;
(b) any refusal, restriction, suspension or withdrawal of a Union technical 
documentation assessment certificate or a quality management system approval 
issued in accordance with the requirements of Annex VII; 
(c) any circumstances affecting the scope of or conditions for notification;
(d) any request for information which they have received from market surveillance 
authorities regarding conformity assessment activities;
(e) on request, conformity assessment activities performed within the scope of their 
notification and any other activity performed, including cross-border activities and 
subcontracting.
2. Each notified body shall inform the other notified bodies of:
(a) quality management system approvals which it has refused, suspended or withdrawn, 
and, upon request, of quality system approvals which it has issued;
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(b) EU technical documentation assessment certificates or any supplements thereto 
which it has refused, withdrawn, suspended or otherwise restricted, and, upon 
request, of the certificates and/or supplements thereto which it has issued.
3. Each notified body shall provide the other notified bodies carrying out similar conformity 
assessment activities covering the same AI systems with relevant information on issues 
relating to negative and, on request, positive conformity assessment results.
4. The obligations referred to in paragraphs 1 to 3 shall be complied with in accordance with 
Article 70.
Article 47
Derogation from conformity assessment procedure
1. By way of derogation from Article 43 and upon a duly justified request, any market 
surveillance authority may authorise the placing on the market or putting into service of 
specific high-risk AI systems within the territory of the Member State concerned, for 
exceptional reasons of public security or the protection of life and health of persons, 
environmental protection and the protection of key industrial and infrastructural assets. 
That authorisation shall be for a limited period of time while the necessary conformity 
assessment procedures are being carried out, taking into account the exceptional reasons 
justifying the derogation. The completion of those procedures shall be undertaken without 
undue delay.
1a. In a duly justified situation of urgency for exceptional reasons of public security or in case 
of specific, substantial and imminent threat to the life or physical safety of natural persons, 
law enforcement authorities or civil protection authorities may put a specific high-risk AI 
system into service without the authorisation referred to in paragraph 1 provided that such 
authorisation is requested during or after the use without undue delay, and if such 
authorisation is rejected, its use shall be stopped with immediate effect and all the results 
and outputs of this use shall be immediately discarded.
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2. The authorisation referred to in paragraph 1 shall be issued only if the market surveillance 
authority concludes that the high-risk AI system complies with the requirements of Chapter 
2 of this Title. The market surveillance authority shall inform the Commission and the 
other Member States of any authorisation issued pursuant to paragraph 1. This obligation 
shall not cover sensitive operational data in relation to the activities of law enforcement 
authorities.
3. [deleted] 
4. [deleted] 
5. [deleted] 
6. For high-risk AI systems related to products covered by Union harmonisation legislation
referred to in Annex II Section A, only the conformity assessment derogation procedures 
established in that legislation shall apply.
Article 48
EU declaration of conformity
1. The provider shall draw up a written or electronically signed EU declaration of conformity 
for each AI system and keep it at the disposal of the national competent authorities for 10 
years after the AI system has been placed on the market or put into service. The EU 
declaration of conformity shall identify the AI system for which it has been drawn up. A 
copy of the EU declaration of conformity shall be submitted to the relevant national 
competent authorities upon request.
2. The EU declaration of conformity shall state that the high-risk AI system in question meets 
the requirements set out in Chapter 2 of this Title. The EU declaration of conformity shall 
contain the information set out in Annex V and shall be translated into a language that can 
be easily understood by the national competent authorities of the Member State(s) in which 
the high-risk AI system is made available. 
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3. Where high-risk AI systems are subject to other Union harmonisation legislation which 
also requires an EU declaration of conformity, a single EU declaration of conformity shall 
be drawn up in respect of all Union legislations applicable to the high-risk AI system. The 
declaration shall contain all the information required for identification of the Union 
harmonisation legislation to which the declaration relates. 
4. By drawing up the EU declaration of conformity, the provider shall assume responsibility 
for compliance with the requirements set out in Chapter 2 of this Title. The provider shall 
keep the EU declaration of conformity up-to-date as appropriate.
5. The Commission shall be empowered to adopt delegated acts in accordance with Article 73 
for the purpose of updating the content of the EU declaration of conformity set out in 
Annex V in order to introduce elements that become necessary in light of technical 
progress.
Article 49
CE marking of conformity
1. The CE marking of conformity shall be subject to the general principles set out in Article 
30 of Regulation (EC) No 765/2008. 
2. The CE marking shall be affixed visibly, legibly and indelibly for high-risk AI systems. 
Where that is not possible or not warranted on account of the nature of the high-risk AI 
system, it shall be affixed to the packaging or to the accompanying documentation, as 
appropriate.
3. Where applicable, the CE marking shall be followed by the identification number of the 
notified body responsible for the conformity assessment procedures set out in Article 43. 
The identification number shall also be indicated in any promotional material which 
mentions that the high-risk AI system fulfils the requirements for CE marking.
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Article 50
[deleted]
Article 51
Registration of relevant operators and of high-risk AI systems listed in Annex III
1. Before placing on the market or putting into service a high-risk AI system listed in Annex 
III with the exception of high-risk AI systems referred to in Annex III, points 1, 6 and 7 in 
the areas of law enforcement, migration, asylum and border control management, and high 
risk AI systems referred to in Annex III point 2, the provider and where applicable, the 
authorised representative shall register themselves in the EU database referred to in Article 
60. The provider or, where applicable the authorised representative, shall also register their 
systems in that database.
2. Before using a high-risk AI system listed in Annex III, users of high-risk AI systems that 
are public authorities, agencies or bodies, or entities acting on their behalf, shall register 
themselves in the EU database referred to in Article 60 and select the system that they 
envisage to use.
The obligations laid down in the previous subparagraph shall not apply to law 
enforcement, border control, immigration or asylum authorities, agencies or bodies and 
authorities, agencies or bodies using high-risk AI systems referred to Annex III point 2, as 
well as to entities acting on their behalf.
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TITLE IV
TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND USERS OF
CERTAIN AI SYSTEMS
Article 52
Transparency obligations for providers and users of certain AI systems
1. Providers shall ensure that AI systems intended to interact with natural persons are 
designed and developed in such a way that natural persons are informed that they are 
interacting with an AI system, unless this is obvious from the point of view of a natural 
person who is reasonably well-informed, observant and circumspect, taking into account
the circumstances and the context of use. This obligation shall not apply to AI systems 
authorised by law to detect, prevent, investigate and prosecute criminal offences, subject to 
appropriate safeguards for the rights and freedoms of third parties, unless those systems are 
available for the public to report a criminal offence.
2. Users of a biometric categorisation system shall inform of the operation of the system the 
natural persons exposed thereto. This obligation shall not apply to AI systems used for 
biometric categorisation, which are permitted by law to detect, prevent and investigate 
criminal offences, subject to appropriate safeguards for the rights and freedoms of third 
parties.
2a. Users of an emotion recognition system shall inform of the operation of the system the 
natural persons exposed thereto. This obligation shall not apply to AI systems used for 
emotion recognition which are permitted by law to detect, prevent and investigate criminal 
offences, subject to appropriate safeguards for the rights and freedoms of third parties. 
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3. Users of an AI system that generates or manipulates image, audio or video content that 
appreciably resembles existing persons, objects, places or other entities or events and 
would falsely appear to a person to be authentic or truthful (‘deep fake’), shall disclose that 
the content has been artificially generated or manipulated. 
However, the first subparagraph shall not apply where the use is authorised by law to 
detect, prevent, investigate and prosecute criminal offences or where the content is part of 
an evidently creative, satirical, artistic or fictional work or programme subject to 
appropriate safeguards for the rights and freedoms of third parties.
3a. The information referred to in paragraphs 1 to 3 shall be provided to natural persons in a 
clear and distinguishable manner at the latest at the time of the first interaction or exposure.
4. Paragraphs 1, 2, 2a and 3 and 3a shall not affect the requirements and obligations set out in 
Title III of this Regulation and shall be without prejudice to other transparency obligations 
for users of AI systems laid down in Union or national law.
TITLE V
MEASURES IN SUPPORT OF INNOVATION
Article 53
AI regulatory sandboxes 
-1a. National competent authorities may establish AI regulatory sandboxes for the 
development, training, testing and validation of innovative AI systems under the direct 
supervision, guidance and support by the national competent authority, before those 
systems are placed on the market or put into service. Such regulatory sandboxes may 
include testing in real world conditions supervised by the national competent authorities.
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-1b. [deleted]
-1c Where appropriate, national competent authorities shall cooperate with other relevant 
authorities and may allow for the involvement of other actors within the AI ecosystem.
-1d. This Article shall not affect other regulatory sandboxes established under national or Union 
law, including in cases where the products or services that are tested in them are linked to 
the use of innovative AI systems. Member States shall ensure an appropriate level of 
cooperation between the authorities supervising those other sandboxes and the national 
competent authorities.
1. [deleted] 
1a. [deleted] 
1b. The establishment of AI regulatory sandboxes under this Regulation shall aim to contribute 
to one or more of the following objectives:
a) foster innovation and competitiveness and facilitate the development of an AI 
ecosystem;
b) facilitate and accelerate access to the Union market for AI systems, in particular when 
provided by small and medium enterprises (SMEs), including start-ups;
c) improve legal certainty and contribute to the sharing of best practices through 
cooperation with the authorities involved in the AI regulatory sandbox with a view to 
ensuring future compliance with this Regulation and, where appropriate, with other 
Union and Member States legislation;
d) contribute to evidence-based regulatory learning.
2. [deleted]
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2a. Access to the AI regulatory sandboxes shall be open to any provider or prospective 
provider of an AI system who fulfils the eligibility and selection criteria referred to in 
paragraph 6(a) and who has been selected by the national competent authorities following 
the selection procedure referred to in paragraph 6(b). Providers or prospective providers 
may also submit applications in partnership with users or any other relevant third parties.
Participation in the AI regulatory sandbox shall be limited to a period that is appropriate to 
the complexity and scale of the project. This period may be extended by the national 
competent authority. 
Participation in the AI regulatory sandbox shall be based on a specific plan referred to in 
paragraph 6 of this Article that shall be agreed between the participant(s) and the national 
competent authoritie(s), as applicable. 
3. The participation in the AI regulatory sandboxes shall not affect the supervisory and 
corrective powers of the authorities supervising the sandbox. Those authorities shall 
exercice their supervisory powers in a flexible manner within the limits of the relevant 
legislation, using their discretionary powers when implementing legal provisions to a 
specific AI sandbox project, with the objective of supporting innovation in AI in the 
Union.
Provided that the participant(s) respect the sandbox plan and the terms and conditions for 
their participation as referred to in paragraph 6(c) and follow in good faith the guidance 
given by the authorities, no administrative fines shall be imposed by the authorities for 
infringement of applicable Union or Member State legislation relating to the AI system 
supervised in the sandbox, including the provisions of this Regulation. 
4. The participants remain liable under applicable Union and Member States liability 
legislation for any damage caused in the course of their participation in an AI regulatory 
sandbox.
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4a. Upon request of the provider or prospective provider of the AI system, the national 
competent authority shall provide, where applicable, a written proof of the activities 
successfully carried out in the sandbox. The national competent authority shall also 
provide an exit report detailing the activities carried out in the sandbox and the related 
results and learning outcomes. Such written proof and exit report could be taken into 
account by market surveillance authorities or notified bodies, as applicable, in the context 
of conformity assessment procedures or market surveillance checks. 
Subject to the confidentiality provisions in Article 70 and with the agreement of the 
sandbox participants, the European Commission and the AI Board shall be authorised to 
access the exit reports and shall take them into account, as appropriate, when exercising 
their tasks under this Regulation. If both the participant and the national competent 
authority explicitly agree to this, the exit report can be made publicly available through the 
single information platform referred to in article 55(3)(b).
4b. The AI regulatory sandboxes shall be designed and implemented in such a way that, where 
relevant, they facilitate cross-border cooperation between the national competent 
authorities. 
5. National competent authorities shall make publicly available annual reports on the 
implementation of the AI regulatory sandboxes, including good practices, lessons learnt 
and recommendations on their setup and, where relevant, on the application of this 
Regulation and other Union legislation supervised within the sandbox. Those annual 
reports shall be submitted to the AI Board which shall make publicly available a summary 
of all good practices, lessons learnt and recommendations. This obligation to make annual 
reports publicly available shall not cover sensitive operational data in relation to the 
activities of law enforcement, border control, immigration or asylum authorities. The 
Commission and the AI Board shall, where appropriate, take the annual reports into 
account when exercising their tasks under this Regulation.
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5b. The Commission shall ensure that information about AI regulatory sandboxes, including 
about those established under this Article, is available through the single information 
platform referred to in Article 55(3)(b).
6. The modalities and the conditions for the establishment and operation of the AI regulatory 
sandboxes under this Regulation shall be adopted through implementing acts in accordance 
with the examination procedure referred to in Article 74(2).
The modalities and conditions shall to the best extent possible support flexibility for 
national competent authorities to establish and operate their AI regulatory sandboxes, 
foster innovation and regulatory learning and shall particularly take into account the 
special circumstances and capacities of participating SMEs, including start-ups.
Those implementing acts shall include common main principles on the following issues:
a) eligibility and selection for participation in the AI regulatory sandbox; 
b) procedure for the application, participation, monitoring, exiting from and 
termination of the AI regulatory sandbox, including the sandbox plan and the exit 
report; 
c) the terms and conditions applicable to the participants.
7. When national competent authorities consider authorising testing in real world conditions 
supervised within the framework of an AI regulatory sandbox established under this 
Article, they shall specifically agree with the participants on the terms and conditions of 
such testing and in particular on the appropriate safeguards with the view to protect 
fundamental rights, health and safety. Where appropriate, they shall cooperate with other 
national competent authorities with a view to ensure consistent practices across the Union.
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Article 54
Further processing of personal data for developing certain AI systems in the public interest in the 
AI regulatory sandbox
1. In the AI regulatory sandbox personal data lawfully collected for other purposes may be 
processed for the purposes of developing, testing and training of innovative AI systems in 
the sandbox under the following cumulative conditions:
(a) the innovative AI systems shall be developed for safeguarding substantial public 
interest by a public authority or another natural or legal person governed by public 
law or by private law and in one or more of the following areas:
(i) [deleted] 
(ii) public safety and health, including prevention, control and treatment of disease 
and improvement of health care systems;
(iii) protection and improvement of the quality of the environment, including green 
transition, climate change mitigation and adaptation; 
(iv) energy sustainability, transport and mobility; 
(v) efficiency and quality of public administration and public services;
(vi) cybersecurity and resilience of critical infrastructure.
(b) the data processed are necessary for complying with one or more of the requirements 
referred to in Title III, Chapter 2 where those requirements cannot be effectively 
fulfilled by processing anonymised, synthetic or other non-personal data;
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(c) there are effective monitoring mechanisms to identify if any high risks to the rights 
and freedoms of the data subjects, as referred to in Article 35 of Regulation (EU) 
2016/679 and in Article 39 of Regulation (EU) 2018/1725, may arise during the 
sandbox experimentation as well as response mechanism to promptly mitigate those 
risks and, where necessary, stop the processing; 
(d) any personal data to be processed in the context of the sandbox are in a functionally 
separate, isolated and protected data processing environment under the control of the 
participants and only authorised persons have access to that data; 
(e) any personal data processed are not to be transmitted, transferred or otherwise 
accessed by other parties that are not participants in the sandbox, unless such 
disclosure occurs in compliance with Regulation (EU) 2016/679 or, where 
applicable, Regulation 2018/725, and all participants have agreed to it; 
(f) any processing of personal data in the context of the sandbox shall not affect the 
application of the rights of the data subjects as provided for under Union law on the 
protection of personal data, in particular in Article 22 of Regulation (EU) 2016/679 
and Article 24 of Regulation (EU) 2018/1725;
(g) any personal data processed in the context of the sandbox are protected by means of 
appropriate technical and organisational measures and deleted once the participation 
in the sandbox has terminated or the personal data has reached the end of its retention 
period; 
(h) the logs of the processing of personal data in the context of the sandbox are kept for 
the duration of the participation in the sandbox, unless provided otherwise by Union 
or national law;
(i) complete and detailed description of the process and rationale behind the training, 
testing and validation of the AI system is kept together with the testing results as part 
of the technical documentation in Annex IV;
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(j) a short summary of the AI project developed in the sandbox, its objectives and 
expected results published on the website of the competent authorities. This 
obligation shall not cover sensitive operational data in relation to the activities of law 
enforcement, border control, immigration or asylum authorities.
1a. For the purpose of prevention, investigation, detection or prosecution of criminal offences 
or the execution of criminal penalties, including the safeguarding against and the 
prevention of threats to public security, under the control and responsibility of law 
enforcement authorities, the processing of personal data in AI regulatory sandboxes shall 
be based on a specific Member State or Union law and subject to the same cumulative 
conditions as referred to in paragraph 1.
2. Paragraph 1 is without prejudice to Union or Member States laws laying down the basis for 
the processing of personal data which is necessary for the purpose of developing, testing 
and training of innovative AI systems or any other legal basis, in compliance with Union 
law on the protection of personal data.
Article 54a
Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes
1. Testing of AI systems in real world conditions outside AI regulatory sandboxes may be 
conducted by providers or prospective providers of high-risk AI systems listed in Annex 
III, in accordance with the provisions of this Article and the real-world testing plan 
referred to in this Article.
The detailed elements of the real-world testing plan shall be specified in implementing acts 
adopted by the Commission in accordance with the examination procedure referred to in 
Article 74(2).
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This provision shall be without prejudice to Union or Member State legislation for the 
testing in real world conditions of high-risk AI systems related to products covered by 
legislation listed in Annex II.
2. Providers or prospective providers may conduct testing of high-risk AI systems referred to 
in Annex III in real world conditions at any time before the placing on the market or 
putting into service of the AI system on their own or in partnership with one or more 
prospective users. 
3. The testing of high-risk AI systems in real world conditions under this Article shall be 
without prejudice to ethical review that may be required by national or Union law. 
4. Providers or prospective providers may conduct the testing in real world conditions only 
where all of the following conditions are met: 
(a) the provider or prospective provider has drawn up a real-world testing plan and 
submitted it to the market surveillance authority in the Member State(s) where the 
testing in real world conditions is to be conducted;
(b) the market surveillance authority in the Member State(s) where the testing in real 
world conditions is to be conducted have not objected to the testing within 30 days 
after its submission; 
(c) the provider or prospective provider with the exception of high-risk AI systems 
referred to in Annex III, points 1, 6 and 7 in the areas of law enforcement, migration, 
asylum and border control management, and high risk AI systems referred to in Annex 
III point 2, has registered the testing in real world conditions in the EU database 
referred to in Article 60(5a) with a Union-wide unique single identification number 
and the information specified in Annex VIIIa;
(d) the provider or prospective provider conducting the testing in real world conditions is 
established in the Union or it has appointed a legal representative for the purpose of 
the testing in real world conditions who is established in the Union;
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(e) data collected and processed for the purpose of the testing in real world conditions 
shall not be transferred to countries outside the Union, unless the transfer and the 
processing provides equivalent safeguards to those provided under Union law;
(f) the testing in real world conditions does not last longer than necessary to achieve its 
objectives and in any case not longer than 12 months;
(g) persons belonging to vulnerable groups due to their age, physical or mental disability 
are appropriately protected;
(h) [deleted]
(i) where a provider or prospective provider organises the testing in real world conditions 
in cooperation with one or more prospective users, the latter have been informed of all 
aspects of the testing that are relevant to their decision to participate, and given the 
relevant instructions on how to use the AI system referred to in Article 13; the 
provider or prospective provider and the user(s) shall conclude an agreement 
specifying their roles and responsibilities with a view to ensuring compliance with the 
provisions for testing in real world conditions under this Regulation and other 
applicable Union and Member States legislation;
(j) the subjects of the testing in real world conditions have given informed consent in 
accordance with Article 54b, or in the case of law enforcement, where the seeking of 
informed consent would prevent the AI system from being tested, the testing itself and 
the outcome of the testing in the real world conditions shall not have a negative effect
on the subject;
(k) the testing in real world conditions is effectively overseen by the provider or 
prospective provider and user(s) with persons who are suitably qualified in the 
relevant field and have the necessary capacity, training and authority to perform their 
tasks;
(l) the predictions, recommendations or decisions of the AI system can be effectively 
reversed or disregarded.
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5. Any subject of the testing in real world conditions, or his or her legally designated 
representative, as appropriate, may, without any resulting detriment and without having to 
provide any justification, withdraw from the testing at any time by revoking his or her 
informed consent. The withdrawal of the informed consent shall not affect the activities 
already carried out and the use of data obtained based on the informed consent before its 
withdrawal. 
6. Any serious incident identified in the course of the testing in real world conditions shall be 
reported to the national market surveillance authority in accordance with Article 62 of this 
Regulation. The provider or prospective provider shall adopt immediate mitigation 
measures or, failing that, suspend the testing in real world conditions until such mitigation 
takes place or otherwise terminate it. The provider or prospective provider shall establish a 
procedure for the prompt recall of the AI system upon such termination of the testing in 
real world conditions.
7. Providers or prospective providers shall notify the national market surveillance authority in 
the Member State(s) where the testing in real world conditions is to be conducted of the 
suspension or termination of the testing in real world conditions and the final outcomes.
8. The provider and prospective provider shall be liable under applicable Union and Member 
States liability legislation for any damage caused in the course of their participation in the 
testing in real world conditions.
Article 54b
Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes
1. For the purpose of testing in real world conditions under Article 54a, informed consent 
shall be freely given by the subject of testing prior to his or her participation in such testing 
and after having been duly informed with concise, clear, relevant, and understandable 
information regarding:
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(i) the nature and objectives of the testing in real world conditions and the possible 
inconvenience that may be linked to his or her participation; 
(ii) the conditions under which the testing in real world conditions is to be conducted, 
including the expected duration of the subject's participation;
(iii) the subject's rights and guarantees regarding participation, in particular his or her 
right to refuse to participate in and the right to withdraw from testing in real world 
conditions at any time without any resulting detriment and without having to provide 
any justification;
(iv) the modalities for requesting the reversal or the disregard of the predictions, 
recommendations or decisions of the AI system; 
(v) the Union-wide unique single identification number of the testing in real world 
conditions in accordance with Article 54a(4c) and the contact details of the provider 
or its legal representative from whom further information can be obtained.
2. The informed consent shall be dated and documented and a copy shall be given to the 
subject or his or her legal representative.
Article 55
Support measures for operators, in particular SMEs, including start-ups 
1. Member States shall undertake the following actions:
(a) provide SMEs, including start-ups, with priority access to the AI regulatory 
sandboxes to the extent that they fulfil the eligibility and selection criteria;
(b) organise specific awareness raising and training activities about the application of 
this Regulation tailored to the needs of the SMEs, including start-ups, and, as 
appropriate, local public authorities;
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(c) where appropriate, establish a dedicated channel for communication with SMEs, 
including start-ups and, as appropriate, local public authorities to provide advice and 
respond to queries about the implementation of this Regulation, including as regards 
participation in AI regulatory sandboxes.
2. The specific interests and needs of the SME providers, including start-ups, shall be taken 
into account when setting the fees for conformity assessment under Article 43, reducing 
those fees proportionately to their size, market size and other relevant indicators.
3. The Commission shall undertake the following actions:
(a) upon request of the AI Board, provide standardised templates for the areas covered 
by this Regulation;
(b) develop and maintain a single information platform providing easy to use 
information in relation to this Regulation for all operators across the Union;
(c) organise appropriate communication campaigns to raise awareness about the 
obligations arising from this Regulation;
(d) evaluate and promote the convergence of best practices in public procurement 
procedures in relation to AI systems.
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Article 55a
Derogations for specific operators
1. The obligations laid down in Article 17 of this Regulation shall not apply to microenterprises 
as defined in Article 2(3) of the Annex to the Commission Recommendation 2003/361/EC 
concerning the definition of micro, small and medium-sized enterprises, provided those 
enterprises do not have partner enterprises or linked enterprises as defined in Article 3 of the 
same Annex. 
2. Paragraph 1 shall not be interpreted as exempting those operators from fulfilling any other 
requirements and obligations laid down in this Regulation, including those established in 
Articles 9, 61 and 62.
3. Requirements and obligations for general purpose AI systems laid down in Article 4b shall 
not apply to micro, small and medium-sized enterprises, provided those enterprises do not 
have partner enterprises or linked enterprises as defined in Article 3 of the the Annex to the 
Commission Recommendation 2003/361/EC concerning the definition of micro, small and 
medium-sized enterprises.
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TITLE VI
GOVERNANCE
CHAPTER 1
EUROPEAN ARTIFICIAL INTELLIGENCE BOARD
Article 56
Establishment and structure of the European Artificial Intelligence Board
1. A ‘European Artificial Intelligence Board’ (the ‘Board’) is established.
2. The Board shall be composed of one representative per Member State. The European Data 
Protection Supervisor shall participate as an observer. The Commission shall also attend 
the Board’s meetings without taking part in the votes.
Other national and Union authorities, bodies or experts may be invited to the meetings by 
the Board on a case by case basis, where the issues discussed are of relevance for them.
2a. Each representative shall be designated by their Member State for a period of 3 years, 
renewable once. 
2aa. Member States shall ensure that their representatives in the Board:
(i) have the relevant competences and powers in their Member State so as to contribute 
actively to the achievement of the board’s tasks referred to in Article 58;
(ii) are designated as a single contact point vis-à-vis the Board and, where appropriate, 
taking into account Member States’ needs, as a single contact point for stakeholders;
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(iii) are empowered to facilitate consistency and coordination between national 
competent authorities in their Member State as regards the implementation of this 
Regulation, including through the collection of relevant data and information for the 
purpose of fulfilling their tasks on the Board.
3. The designated representatives of the Member States shall adopt the Board’s rules of 
procedure by a two-thirds majority.
The rules of procedure shall, in particular, lay down procedures for the selection process, 
duration of mandate and specifications of the tasks of the Chair, the voting modalities, and 
the organisation of the Board’s activities and its sub-groups. 
The Board shall establish a standing subgroup serving as a platform for stakeholders to 
advise the Board on all issues related to the implementation of this Regulation, including 
on the preparation of implementing and delegated acts. To this purpose, organisations 
representing the interests of the providers and users of AI systems, including SMEs and 
start-ups, as well as civil society organisations, representatives of affected persons, 
researchers, standardisation organisations, notified bodies, laboratories and testing and 
experimentation facilities shall be invited to participate to this sub-group. The Board shall 
establish two standing sub-groups to provide a platform for cooperation and exchange 
among market surveillance authorities and notifying authorities on issues related to market 
surveillance and notified bodies respectively.
The Board may establish other standing or temporary sub-groups as appropriate for the 
purpose of examining specific issues. Where appropriate, stakeholders referred to in the 
previous subparagraph may be invited to such sub-groups or to specific meetings of those 
subgroups in the capacity of observers.
3a. The Board shall be organised and operated so as to safeguard the objectivity and 
impartiality of its activities.
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4. The Board shall be chaired by one of the representatives of the Member States. Upon 
request of the Chair, the Commission shall convene the meetings and prepare the agenda in 
accordance with the tasks of the Board pursuant to this Regulation and its rules of 
procedure. The Commission shall provide administrative and analytical support for the 
activities of the Board pursuant to this Regulation. 
Article 57
[deleted] 
Article 58
Tasks of the Board
The Board shall advice and assist the Commission and the Member States in order to facilitate the 
consistent and effective application of this Regulation. For this purpose the Board may in particular:
(a) collect and share technical and regulatory expertise and best practices among Member 
States;
(b) contribute to the harmonisation of administrative practices in the Member States, including 
in relation to the derogation from the conformity assessment procedures referred to in 
Article 47, the functioning of regulatory sandboxes and testing in real world conditions 
referred to in Article 53, 54 and 54a;
(c) upon the request of the Commission or on its own initiative, issue recommendations and 
written opinions on any relevant matters related to the implementation of this Regulation 
and to its consistent and effective application, including: 
(i) on technical specifications or existing standards regarding the requirements set out in 
Title III, Chapter 2, 
(ii) on the use of harmonised standards or common specifications referred to in Articles 
40 and 41,
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(iii) on the preparation of guidance documents, including the guidelines concerning the 
setting of administrative fines referred to in Article 71;
(d) advise the Commission on the potential need for amendment of Annex III in accordance with 
Articles 4 and 7, taking into account relevant available evidence and the latest develoments in 
technology;
(e) advise the Commission during the preparation of delegated or implementing act pursuant to 
this Regulation;
f) cooperate, as appropriate, with relevant EU bodies, experts groups and networks in particular 
in the fields of product safety, cybersecurity, competition, digital and media services, 
financial services, cryptocurrencies, consumer protection, data and fundamental rights 
protection;
g) contribute and provide relevant advice to the Commission in the development of the guidance 
referred to in Article 58a or request the development of such guidance;
(h) to assist the work of market surveillance authorities and, in cooperation and subject to 
agreement of the concerned market surveillance authorities, promote and support cross-border 
market surveillance investigations, including with respect to the emergence of risks of 
systemic nature that may stem from AI systems;
(i) contribute to the assessment of training needs for staff of Member States involved in 
implementing this Regulation;
(j) advise the Commission in relation to international matters on artificial intelligence.
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CHAPTER 1A
GUIDELINES FROM THE COMMISSION
Article 58a
Guidelines from the Commission on the implementation of this Regulation
1. Upon the request of the Member States or the Board, or on its own initiative, the Commission 
shall issue guidelines on the practical implementation of this Regulation, and in particular on
(i) the application of the requirements referred to in Articles 8 - 15;
(ii) the prohibited practices referred to in Article 5;
(iii) the practical implementation of the provisions related to substantial modification;
(iv) the practical implementation of uniform conditions referred to in Article 6, paragraph 3, 
including examples in relation to high risk AI systems referred to in Annex III;
(v) the practical implementation of transparency obligations laid down in Article 52;
(vi) the relationship of this Regulation with other relevant Union legislation, including as 
regards consistency in their enforcement.
When issuing such guidelines, the Commission shall pay particular attention to the needs of SMEs 
including start-ups, local public authorities and sectors most likely to be affected by this Regulation.
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CHAPTER 2
NATIONAL COMPETENT AUTHORITIES
Article 59
Designation of national competent authorities 
1. [deleted] 
2. Each Member State shall establish or designate at least one notifying authority and at least 
one market surveillance authority for the purpose of this Regulation as national competent 
authorities. These national competent authorities shall be organised so as to safeguard the 
priniciples of objectivity and impartiality of their activities and tasks. Provided that those 
prinicples are respected, such activities and tasks may be performed by one or several 
designated authorities, in accordance with the organisational needs of the Member State. 
3. Member States shall inform the Commission of their designation or designations. 
4. Member States shall ensure that national competent authorities are provided with adequate 
financial resources, technical equipment and well qualified human resources to effectively 
fulfil their tasks under this Regulation. 
5. By [one year after entry into force of this Regulation] and afterwards six months before 
the deadline referred to in Article 84(2) Member States shall inform the Commission on 
the status of the financial resources, technical equipment and human resources of the 
national competent authorities with an assessment of their adequacy. The Commission 
shall transmit that information to the Board for discussion and possible recommendations. 
6. The Commission shall facilitate the exchange of experience between national competent 
authorities.
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7. National competent authorities may provide advice on the implementation of this 
Regulation, including tailored to SME providers, including start-ups. Whenever national 
competent authorities intend to provide guidance and advice with regard to an AI system in 
areas covered by other Union legislation, the competent national authorities under that 
Union legislation shall be consulted, as appropriate. Member States may also establish one 
central contact point for communication with operators.
8. When Union institutions, agencies and bodies fall within the scope of this Regulation, the 
European Data Protection Supervisor shall act as the competent authority for their 
supervision.
TITLE VII
EU DATABASE FOR HIGH-RISK AI SYSTEMS LISTED IN ANNEX III
Article 60
EU database for high-risk AI systems listed in Annex III
1. The Commission shall, in collaboration with the Member States, set up and maintain a EU 
database containing information referred to in paragraph 2 concerning relevant operators 
and high-risk AI systems listed in Annex III which are registered in accordance with 
Articles 51 and 54a. When setting the fuctional specifications of such database, the 
Commission shall consult the AI Board.
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2. The data listed in Annex VIII, Part I, shall be entered into the EU database by the 
providers, authorised representatives and relevant users, as applicable, upon their 
registration. The data listed in Annex VIII, Part II, 1 to 11, shall be entered into the EU 
database by the providers, or where applicable by the authorised representative, in 
accordance with Article 51. The data referred in Annex VIII, Part II, 12 shall be 
automatically generated by the database based on the information provided by relevant 
users pursuant to Article 51(2). The data listed in Annex VIIIa shall be entered into the 
database by the prospective providers or providers in accordance with Article 54a. 
3. [deleted] 
4. The EU database shall contain no personal data, except for the information listed in Annex 
VIII, and shall be without prejudice to Article 70.
5. The Commission shall be the controller of the EU database. It shall make available to 
providers, prospective providers and users adequate technical and administrative support.
5a. Information contained in the EU database registered in accordance with Article 51 shall be 
accessible to the public. The information registered in accordance with Article 54a shall be 
accessible only to market surveillance authorites and the Commission, unless the 
prospective provider or provider has given consent for making this information also 
accessible the public. 
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TITLE VIII
POST-MARKET MONITORING,INFORMATION SHARING, MARKET
SURVEILLANCE
CHAPTER 1
POST-MARKET MONITORING
Article 61
Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems
1. Providers shall establish and document a post-market monitoring system in a manner that 
is proportionate to the risks of the high-risk AI system.
2. In order to allow the provider to evaluate the compliance of AI systems with the 
requirements set out in Title III, Chapter 2 throughout their life cycle, the post-market 
monitoring system shall collect, document and analyse relevant data, which may be 
provided by users or which may be collected through other sources on the performance of 
high-risk AI systems. This obligation shall not cover sensitive operational data of users of 
AI systems which are law enforcement authorities.
3. The post-market monitoring system shall be based on a post-market monitoring plan. The 
post-market monitoring plan shall be part of the technical documentation referred to in 
Annex IV. The Commission shall adopt an implementing act laying down detailed 
provisions establishing a template for the post-market monitoring plan and the list of 
elements to be included in the plan.
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4. For high-risk AI systems covered by the legal acts referred to in Annex II, Section A, 
where a post-market monitoring system and plan is already established under that 
legislation, the post-market monitoring documentation as prepared under that legislation 
shall be deemed sufficient, provided that the template referred to paragraph 3 is used.
The first subparagraph shall also apply high-risk AI systems referred to in point 5 of 
Annex III placed on the market or put into service by financial institutions that are subject 
to requirements regarding their internal governance, arrangements or processes under 
Union financial services legislation.
CHAPTER 2
SHARING OF INFORMATION ON SERIOUS INCIDENTS 
Article 62
Reporting of serious incidents 
1. Providers of high-risk AI systems placed on the Union market shall report any serious 
incident to the market surveillance authorities of the Member States where that incident 
occurred. 
Such notification shall be made immediately after the provider has established a causal link 
between the AI system and the serious incident or the reasonable likelihood of such a link, 
and, in any event, not later than 15 days after the providers becomes aware of the serious 
incident.
2. Upon receiving a notification related to a serious incident referred to in Article 3(44)(c), 
the relevant market surveillance authority shall inform the national public authorities or 
bodies referred to in Article 64(3). The Commission shall develop dedicated guidance to 
facilitate compliance with the obligations set out in paragraph 1. That guidance shall be 
issued 12 months after the entry into force of this Regulation, at the latest.
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3. For high-risk AI systems referred to in point 5 of Annex III which are placed on the market 
or put into service by providers that are financial institutions that are subject to 
requirements regarding their internal governance, arrangements or processes under Union 
financial services legislation, the notification of serious incidents shall be limited to those 
referred to in Article 3(44)(c).
4. For high-risk AI systems which are safety components of devices, or are themselves 
devices, covered by Regulation (EU) 2017/745 and Regulation (EU) 2017/746 the 
notification of serious incidents shall be limited to those referred to in Article 3(44)(c) and 
be made to the national competent authority chosen for this purpose by the Member States 
where that incident occurred.
CHAPTER 3
ENFORCEMENT 
Article 63
Market surveillance and control of AI systems in the Union market
1. Regulation (EU) 2019/1020 shall apply to AI systems covered by this Regulation. 
However, for the purpose of the effective enforcement of this Regulation:
(a) any reference to an economic operator under Regulation (EU) 2019/1020 shall be 
understood as including all operators identified in Article 2 of this Regulation;
(b) any reference to a product under Regulation (EU) 2019/1020 shall be understood as 
including all AI systems falling within the scope of this Regulation.
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2. As part of their reporting obligations under Article 34(4) of Regulation (EU) 2019/1020, 
the market surveillance authorities shall report to the Commission about the outcomes of 
relevant market surveillance activities under this Regulation. 
3. For high-risk AI systems, related to products to which legal acts listed in Annex II, section 
A apply, the market surveillance authority for the purposes of this Regulation shall be the 
authority responsible for market surveillance activities designated under those legal acts or, 
in justified circumstances and provided that coordination is ensured, another relevant 
authority identified by the Member State. 
The procedures referred to in Articles 65, 66, 67 and 68 of this Regulation shall not apply 
to AI systems related to products, to which legal acts listed in Annex II, section A apply, 
when such legal acts already provide for procedures having the same objective. In such a 
case, these sectoral procedures shall apply instead.
4. For high-risk AI systems placed on the market, put into service or used by financial 
institutions regulated by Union legislation on financial services, the market surveillance 
authority for the purposes of this Regulation shall be the relevant national authority 
responsible for the financial supervision of those institutions under that legislation in so far 
as the placement on the market, putting into service or the use of the AI system is in direct 
connection with the provision of those financial services.
By way of a derogation from the previous subparagraph, in justified circumstances and 
provided that coordination is ensured, another relevant authority may be identified by the 
Member State as market surveillance authority for the purposes of this Regulation. 
National market surveillance authorities supervising regulated credit institutions regulated 
under Directive 2013/36/EU, which are participating in the Single Supervisory Mechanism 
(SSM) established by Council Regulation No 1204/2013, should report, without delay, to 
the European Central Bank any information identified in the course of their market 
surveillance activities that may be of potential interest for the European Central Bank’s 
prudential supervisory tasks as specified in that Regulation.
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5. For high-risk AI systems listed in point 1(a) in so far as the systems are used for law 
enforcement purposes, points 6, 7 and 8 of Annex III, Member States shall designate as 
market surveillance authorities for the purposes of this Regulation either the national 
authorities supervising the activities of the law enforcement, border control, immigration,
asylum or judicial authorities, or the competent data protection supervisory authorities 
under Directive (EU) 2016/680, or Regulation 2016/679. Market surveillance activities 
shall in no way affect the independence of judicial authorities or otherwise interfere with 
their activities when acting in their judicial capacity.
6. Where Union institutions, agencies and bodies fall within the scope of this Regulation, the 
European Data Protection Supervisor shall act as their market surveillance authority.
7. Member States shall facilitate the coordination between market surveillance authorities 
designated under this Regulation and other relevant national authorities or bodies which 
supervise the application of Union harmonisation legislation listed in Annex II or other 
Union legislation that might be relevant for the high-risk AI systems referred to in Annex 
III. 
8. Without prejudice to powers provided under Regulation (EU) 2019/1020, and where 
relevant and limited to what is necessary to fulfil their tasks, the market surveillance 
authorities shall be granted full access by the provider to the documentation as well as the 
training, validation and testing datasets used for the development of the high-risk AI 
system, including, where appropriate and subject to security safeguards, through 
application programming interfaces (‘API’) or other relevant technical means and tools 
enabling remote access.
9. Market surveillance authorities shall be granted access to the source code of the high-risk 
AI system upon a reasoned request and only when the following cumulative conditions are 
fulfilled: 
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a) Access to source code is necessary to assess the conformity of a high-risk AI system 
with the requirements set out in Title III, Chapter 2, and 
b) testing/auditing procedures and verifications based on the data and documentation 
provided by the provider have been exhausted or proved insufficient. 
10. Any information and documentation obtained by market surveillance authorities shall be 
treated in compliance with the confidentiality obligations set out in Article 70.
11. Complaints to the relevant market surveillance authority can be submitted by any natural 
or legal person having grounds to consider that there has been an infringement of the 
provisions of this Regulation.
In accordance with Article 11(3)(e) and (7)(a) of Regulation (EU) 2019/1020, complaints 
shall be taken into account for the purpose of conducting the market surveillance activities 
and be handled in line with the dedicated procedures established therefore by the market 
surveillance authorities.
Article 63a
Supervision of testing in real world conditions by market surveillance authorities
1. Market surveillance authorities shall have the competence and powers to ensure that testing 
in real world conditions is in accordance with this Regulation. 
2. Where testing in real world conditions is conducted for AI systems that are supervised 
within an AI regulatory sandbox under Article 54, the market surveillance authorities shall 
verify the compliance with the provisions of Article 54a as part of their supervisory role 
for the AI regulatory sandbox. Those authorities may, as appropriate, allow the testing in 
real world conditions to be conducted by the provider or prospective provider in derogation 
to the conditions set out in Article 54a(4) (f) and (g).
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3. Where a market surveillance authority has been informed by the prospective provider, the 
provider or any third party of a serious incident or has other grounds for considering 
that the conditions set out in Articles 54a and 54b are not met, it may take any of the 
following decisions on its territory, as appropriate:
(a) suspend or terminate the testing in real world conditions;
(b) require the provider or prospective provider and user(s) to modify any aspect of the 
testing in real world conditions.
4. Where a market surveillance authority has taken a decision referred to in paragraph 3 of 
this Article or has issued an objection within the meaning of Article 54a(4)(b), the decision 
or the objection shall indicate the grounds thereof and the modalities and conditions for the 
provider or prospective provider to challenge the decision or objection. 
5. Where applicable, where a market surveillance authority has taken a decision referred to in 
paragraph 3 of this Article, it shall communicate the grounds therefor to the market 
surveillance authorities of the other Member States in which the AI system has been tested 
in accordance with the testing plan.
Article 64
Powers of authorities protecting fundamental rights 
1. [deleted] 
2. [deleted] 
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3. National public authorities or bodies which supervise or enforce the respect of obligations 
under Union law protecting fundamental rights, including the right to non-discrimination,
in relation to the use of high-risk AI systems referred to in Annex III shall have the power 
to request and access any documentation created or maintained under this Regulation when 
access to that documentation is necessary for the fulfilment of the competences under their 
mandate within the limits of their jurisdiction. The relevant public authority or body shall 
inform the market surveillance authority of the Member State concerned of any such 
request.
4. By 3 months after the entering into force of this Regulation, each Member State shall 
identify the public authorities or bodies referred to in paragraph 3 and make the list 
publicly available. Member States shall notify the list to the Commission and all other 
Member States and keep the list up to date. 
5. Where the documentation referred to in paragraph 3 is insufficient to ascertain whether a 
breach of obligations under Union law intended to protect fundamental rights has occurred, 
the public authority or body referred to paragraph 3 may make a reasoned request to the 
market surveillance authority to organise testing of the high-risk AI system through 
technical means. The market surveillance authority shall organise the testing with the close 
involvement of the requesting public authority or body within reasonable time following 
the request. 
6. Any information and documentation obtained by the national public authorities or bodies 
referred to in paragraph 3 pursuant to the provisions of this Article shall be treated in 
compliance with the confidentiality obligations set out in Article 70.
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Article 65
Procedure for dealing with AI systems presenting a risk at national level
1. AI systems presenting a risk shall be understood as a product presenting a risk defined in 
Article 3, point 19 of Regulation (EU) 2019/1020 insofar as risks to the health or safety or 
to fundamental rights of persons are concerned.
2. Where the market surveillance authority of a Member State has sufficient reasons to 
consider that an AI system presents a risk as referred to in paragraph 1, they shall carry out 
an evaluation of the AI system concerned in respect of its compliance with all the 
requirements and obligations laid down in this Regulation. When risks to fundamental 
rights are identified, the market surveillance authority shall also inform the relevant 
national public authorities or bodies referred to in Article 64(3). The relevant operators 
shall cooperate as necessary with the market surveillance authorities and the other national 
public authorities or bodies referred to in Article 64(3).
Where, in the course of that evaluation, the market surveillance authority finds that the AI 
system does not comply with the requirements and obligations laid down in this 
Regulation, it shall without undue delay require the relevant operator to take all appropriate 
corrective actions to bring the AI system into compliance, to withdraw the AI system from 
the market, or to recall it, within a period it may prescribe.
The market surveillance authority shall inform the relevant notified body accordingly. 
Article 18 of Regulation (EU) 2019/1020 shall apply to the measures referred to in the 
second subparagraph.
3. Where the market surveillance authority considers that non-compliance is not restricted to 
its national territory, it shall inform the Commission and the other Member States without 
undue delay of the results of the evaluation and of the actions which it has required the 
operator to take.
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4. The operator shall ensure that all appropriate corrective action is taken in respect of all the 
AI systems concerned that it has made available on the market throughout the Union.
5. Where the operator of an AI system does not take adequate corrective action within the 
period referred to in paragraph 2, the market surveillance authority shall take all 
appropriate provisional measures to prohibit or restrict the AI system's being made 
available on its national market, to withdraw the product from that market or to recall it. 
That authority shall notify the Commission and the other Member States, without undue 
delay, of those measures.
6. The notification referred to in paragraph 5 shall include all available details, in particular 
the information necessary for the identification of the non-compliant AI system, the origin 
of the AI system, the nature of the non-compliance alleged and the risk involved, the 
nature and duration of the national measures taken and the arguments put forward by the 
relevant operator. In particular, the market surveillance authorities shall indicate whether 
the non-compliance is due to one or more of the following:
(-a) non-compliance with the prohibition of the artificial intelligence practices referred to 
in Article 5;
(a) a failure of a high-risk AI system to meet requirements set out in Title III, Chapter 2; 
(b) shortcomings in the harmonised standards or common specifications referred to in 
Articles 40 and 41 conferring a presumption of conformity.
(c) non-compliance with provisions set out in Article 52;
(d) non-compliance of general purpose AI systems with the requirements and obligations 
referred to in Article 4a;
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7. The market surveillance authorities of the Member States other than the market 
surveillance authority of the Member State initiating the procedure shall without undue 
delay inform the Commission and the other Member States of any measures adopted and of 
any additional information at their disposal relating to the non-compliance of the AI 
system concerned, and, in the event of disagreement with the notified national measure, of 
their objections.
8. Where, within three months of receipt of the notification referred to in paragraph 5, no 
objection has been raised by either a Member State or the Commission in respect of a 
provisional measure taken by a Member State, that measure shall be deemed justified. This 
is without prejudice to the procedural rights of the concerned operator in accordance with 
Article 18 of Regulation (EU) 2019/1020. The period referred to in the first sentence of 
this paragraph shall be reduced to 30 days in the case of non-compliance with the 
prohibition of the artificial intelligence practices referred to in Article 5.
9. The market surveillance authorities of all Member States shall then ensure that appropriate 
restrictive measures are taken in respect of the AI system concerned, such as withdrawal of 
the product from their market, without undue delay.
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Article 66
Union safeguard procedure
1. Where, within three months of receipt of the notification referred to in Article 65(5), or 30 
days in the case of non-compliance with the prohibition of the artificial intelligence 
practices referred to in Article 5, objections are raised by a Member State against a 
measure taken by another Member State, or where the Commission considers the measure 
to be contrary to Union law, the Commission shall without undue delay enter into 
consultation with the relevant Member State’s market surveillance authority and operator 
or operators and shall evaluate the national measure. On the basis of the results of that 
evaluation, the Commission shall decide whether the national measure is justified or not 
within 9 months, or 60 days in the case of non-compliance with the prohibition of the 
artificial intelligence practices referred to in Article 5, starting from the notification 
referred to in Article 65(5). It shall and notify such decision to the Member State 
concerned. The Commission shall also inform all other Member States of such decision.
2. If the measure taken by the relevant Member State’s market surveillance authority is 
considered justified by the Commission, the market surveillance authorities of all Member 
States shall ensure that appropriate restrictive measures are taken in respect of the AI 
system concerned, such as withdrawal of the AI system from their market without undue 
delay, and shall inform the Commission accordingly. If the national measure is considered 
unjustified by the Commission, the market surveillance authority of the Member State 
concerned shall withdraw the measure and inform the Commission accordingly.
3. Where the national measure is considered justified and the non-compliance of the AI 
system is attributed to shortcomings in the harmonised standards or common specifications 
referred to in Articles 40 and 41 of this Regulation, the Commission shall apply the 
procedure provided for in Article 11 of Regulation (EU) No 1025/2012.
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Article 67
Compliant high-risk or general purpose AI systems which present a risk
1. Where, having performed an evaluation under Article 65, the market surveillance authority 
of a Member State finds that although a high-risk or general purpose AI system is in 
compliance with this Regulation, it presents a risk to the health or safety of persons or to 
fundamental rights, it shall require the relevant operator to take all appropriate measures to 
ensure that the AI system concerned, when placed on the market or put into service, no 
longer presents that risk, to withdraw the AI system from the market or to recall it without 
undue delay, within a period it may prescribe.
2. The provider or other relevant operators shall ensure that corrective action is taken in 
respect of all the AI systems concerned that they have made available on the market 
throughout the Union within the timeline prescribed by the market surveillance authority of 
the Member State referred to in paragraph 1.
3. The Member State shall immediately inform the Commission and the other Member States. 
That information shall include all available details, in particular the data necessary for the 
identification of the AI system concerned, the origin and the supply chain of the AI system, 
the nature of the risk involved and the nature and duration of the national measures taken.
4. The Commission shall without undue delay enter into consultation with the Member States 
concerned and the relevant operator and shall evaluate the national measures taken. On the 
basis of the results of that evaluation, the Commission shall decide whether the measure is 
justified or not and, where necessary, propose appropriate measures.
5. The Commission shall address its decision to the Member States concerned, and inform all 
other Member States.
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Article 68
Formal non-compliance
1. Where the market surveillance authority of a Member State makes one of the following 
findings, it shall require the relevant provider to put an end to the non-compliance 
concerned, within a period it may prescribe:
(a) the conformity marking has been affixed in violation of Article 49;
(b) the conformity marking has not been affixed;
(c) the EU declaration of conformity has not been drawn up;
(d) the EU declaration of conformity has not been drawn up correctly;
(e) the identification number of the notified body, which is involved in the conformity 
assessment procedure, where applicable, has not been affixed;
2. Where the non-compliance referred to in paragraph 1 persists, the Member State concerned 
shall take all appropriate measures to restrict or prohibit the high-risk AI system being 
made available on the market or ensure that it is recalled or withdrawn from the market.
Article 68a
Union testing facilities in the area of artificial intelligence
1. The Commission shall designate one or more Union testing facilities pursuant to Article 21 
of Regulation (EU) 1020/2019 in the area of artificial intelligence. 
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2. Without prejudice to the activities of Union testing facilities referred to in Article 21(6) of 
Regulation (EU) 1020/2019, Union testing facilities referred to in paragraph 1 shall also 
provide independent technical or scientific advice at the request of the Board or market 
surveillance authorities. 
Article 68b
Central pool of independent experts
1. Upon request of the AI Board, the Commission shall, by means of an implementing act, 
make provisions on the creation, maintenance and financing of a central pool of 
independent experts to support the enforcement activities under this Regulation. 
2. Experts shall be selected by the Commission and included in the central pool on the basis 
of up-to-date scientific or technical expertise in the field of artificial intelligence, having 
due regard to the technical areas covered by the requirements and obligations in this 
Regulation and the activities of market surveillance authorities pursuant to Article 11 of 
Regulation (EU) 1020/2019. The Commission shall determine the number of experts in the 
pool in accordance with the required needs. 
3. Experts may have the following tasks:
(a) provide advice to and support the work of market surveillance authorities, at their 
request;
(b) support cross-border market surveillance investigations as referred to in Article 58(h), 
without prejudice of the powers of market surveillance authorities; 
(c) advise and support the Commission when carrying out its duties in the context of the 
safeguard clause pursuant to Article 66.
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4. The experts shall perform their tasks with impartiality, objectivity and ensure the 
confidentiality of information and data obtained in carrying out their tasks and activities. 
Each expert shall draw up a declaration of interests, which shall be made publicly 
available. The Commission shall establish systems and procedures to actively manage and 
prevent potential conflicts of interest.
5. The Member States may be required to pay fees for the advice and support by the experts. 
The structure and the level of fees as well as the scale and structure of recoverable costs 
shall be adopted by the Commission by means of the implementing act referred to in 
paragraph 1, taking into account the objectives of the adequate implementation of this 
Regulation, cost-effectiveness and the necessity to ensure an effective access to experts by 
all Member States. 
6. The Commission shall facilitate timely access to the experts by the Member States, as 
needed, and ensure that the combination of support activities carried out by Union testing 
facilities pursuant to Article 68a and experts pursuant to this Article is efficiently organised 
and provides the best possible added value.
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TITLE IX
CODES OF CONDUCT
Article 69
Codes of conduct for voluntary application of specific requirements
1. The Commission, and the Member States shall facilitate the drawing up of codes of 
conduct intended to encourage the voluntary application to AI systems other than high-risk 
AI systems of one or more of the requirements set out in Title III, Chapter 2 of this 
Regulation to the best extent possible, taking into account the available, technical solutions 
allowing for the application of such requirements. 
2. The Commission and the Member States shall facilitate the drawing up of codes of conduct 
intended to encourage the voluntary application to all AI systems of specific requirements 
related, for example, to environmental sustainability, including as regards energy-efficient 
programming, accessibility for persons with a disability, stakeholders participation in the 
design and development of the AI systems and diversity of development teams on the basis 
of clear objectives and key performance indicators to measure the achievement of those 
objectives. The Commission and the Member States shall also facilitate, where appropriate, 
the drawing of codes of conduct applicable on a voluntary basis with regard to users' 
obligations in relation to AI systems.
3. Codes of conduct applicable on a voluntary basis may be drawn up by individual providers 
of AI systems or by organisations representing them or by both, including with the 
involvement of users and any interested stakeholders and their representative 
organisations, or, where appropriate, by users with regard to their obligations. Codes of 
conduct may cover one or more AI systems taking into account the similarity of the 
intended purpose of the relevant systems.
4. The Commission and the Member States shall take into account the specific interests and 
needs of SME providers, including start-ups, when encouraging and facilitating the 
drawing up of codes of conduct referred to in this Article.
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TITLE X
CONFIDENTIALITY AND PENALTIES
Article 70
Confidentiality
1. National competent authorities, notified bodies, the Commission, the Board, and any other 
natural or legal person involved in the application of this Regulation shall, in accordance 
with Union or national law, put appropriate technical and organisational measures in place 
to ensure the confidentiality of information and data obtained in carrying out their tasks 
and activities in such a manner as to protect, in particular:
(a) intellectual property rights, and confidential business information or trade secrets of a 
natural or legal person, including source code, except the cases referred to in Article 5 of 
Directive 2016/943 on the protection of undisclosed know-how and business information 
(trade secrets) against their unlawful acquisition, use and disclosure apply. 
(b) the effective implementation of this Regulation, in particular for the purpose of 
inspections, investigations or audits;
(c) public and national security interests; 
(d) integrity of criminal or administrative proceedings;
(e) the integrity of information classified in accordance with Union or national law.
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2. Without prejudice to paragraph 1, information exchanged on a confidential basis between 
the national competent authorities and between national competent authorities and the 
Commission shall not be disclosed without the prior consultation of the originating 
national competent authority and the user when high-risk AI systems referred to in points 
1, 6 and 7 of Annex III are used by law enforcement, border control, immigration or 
asylum authorities, when such disclosure would jeopardise public and national security 
interests. This obligation to exchange information shall not cover sensitive operational 
data in relation to the activities of law enforcement, border control, immigration or asylum 
authorities.
When the law enforcement, immigration or asylum authorities are providers of high-risk 
AI systems referred to in points 1, 6 and 7 of Annex III, the technical documentation 
referred to in Annex IV shall remain within the premises of those authorities. Those 
authorities shall ensure that the market surveillance authorities referred to in Article 63(5) 
and (6), as applicable, can, upon request, immediately access the documentation or obtain a 
copy thereof. Only staff of the market surveillance authority holding the appropriate level 
of security clearance shall be allowed to access that documentation or any copy thereof.
3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member 
States and their relevant authorities, as well as notified bodies, with regard to the exchange 
of information and the dissemination of warnings, including in the context of cross-border 
cooperation, nor the obligations of the parties concerned to provide information under 
criminal law of the Member States.
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Article 71
Penalties
1. In compliance with the terms and conditions laid down in this Regulation, Member States 
shall lay down the rules on penalties, including administrative fines, applicable to 
infringements of this Regulation and shall take all measures necessary to ensure that they 
are properly and effectively implemented. The penalties provided for shall be effective, 
proportionate, and dissuasive. They shall take into particular account the size and interests 
of SME providers, including start-ups, and their economic viability. They shall also take 
into account whether the use of the AI system is in the context of personal nonprofessional activity.
2. The Member States shall without delay notify the Commission of those rules and of those 
measures and of any subsequent amendment affecting them. 
3. Non-compliance with any of the prohibitions of the artificial intelligence practices referred 
to in Article 5 shall be subject to administrative fines of up to 30 000 000 EUR or, if the 
offender is company, up to 6 % of its total worldwide annual turnover for the preceding 
financial year, whichever is higher. In case of SMEs, including start-ups, these fines shall 
be up to 3% of their worldwide annual turnover for the preceding financial year.
4. Infringements of the following provisions related to operators or notified bodies, shall be 
subject to administrative fines of up to 20 000 000 EUR or, if the offender is a company, 
up to 4 % of its total worldwide annual turnover for the preceding financial year, 
whichever is higher:
-a) obligations of providers pursuant to Articles 4b and 4c;
a) obligations of providers pursuant to Article 16;
b) obligations for certain other persons pursuant to Article 23a;
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c) obligations of authorised representatives pursuant to Article 25;
d) obligations of importers pursuant to Article 26;
e) obligations of distributors pursuant to Article 27;
f) obligations of users pursuant to Article 29, paragraphs 1 to 6a;
g) requirements and obligations of notified bodies pursuant to Article 33, 34(1), 34(3), 
34(4), 34a;
h) transparency obligations for providers and users pursuant to Article 52.
In case of SMEs, including start-ups, these fines shall be up to 2% of their worldwide 
annual turnover for the preceding financial year.
5. The supply of incorrect, incomplete or misleading information to notified bodies and 
national competent authorities in reply to a request shall be subject to administrative fines 
of up to 10 000 000 EUR or, if the offender is a company, up to 2 % of its total worldwide 
annual turnover for the preceding financial year, whichever is higher. In case of SMEs, 
including start-ups, these fines shall be up to 1% of their worldwide annual turnover for 
the preceding financial year.
6. When deciding on the amount of the administrative fine in each individual case, all 
relevant circumstances of the specific situation shall be taken into account and due regard 
shall be given to the following:
(a) the nature, gravity and duration of the infringement and of its consequences;
(aa) the intentional or negligent character of the infringement;
(ab) any action taken by the operator in order to remedy the infringement and mitigate the 
possible adverse effects of the infringement;
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(b) whether administrative fines have been already applied by other market surveillance 
authorities in other Member States to the same operator for the same infringement;
(ba) whether administrative fines have been already applied by other authorities to the 
same operator for infringements of other Union or national law, when such 
infringements result from the same activity or omission constituting a relevant 
infringement of this Act;
(c) the size, the annual turnover and market share of the operator committing the 
infringement;
(d) any other aggravating or mitigating factor applicable to the circumstances of the 
case, such as financial benefits gained, or losses avoided, directly or indirectly, from 
the infringement.
7. Each Member State shall lay down rules on whether and to what extent administrative 
fines may be imposed on public authorities and bodies established in that Member State.
8. Depending on the legal system of the Member States, the rules on administrative fines may 
be applied in such a manner that the fines are imposed by competent national courts or 
other bodies as applicable in those Member States. The application of such rules in those 
Member States shall have an equivalent effect.
9. The exercise by the market surveillance authority of its powers under this Article shall be 
subject to appropriate procedural safeguards in accordance with Union and Member State 
law, including effective judicial remedy and due process.
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Article 72
Administrative fines on Union institutions, agencies and bodies
1. The European Data Protection Supervisor may impose administrative fines on Union 
institutions, agencies and bodies falling within the scope of this Regulation. When deciding 
whether to impose an administrative fine and deciding on the amount of the administrative 
fine in each individual case, all relevant circumstances of the specific situation shall be 
taken into account and due regard shall be given to the following:
(a) the nature, gravity and duration of the infringement and of its consequences;
(b) the cooperation with the European Data Protection Supervisor in order to remedy the 
infringement and mitigate the possible adverse effects of the infringement, including 
compliance with any of the measures previously ordered by the European Data 
Protection Supervisor against the Union institution or agency or body concerned with 
regard to the same subject matter;
(c) any similar previous infringements by the Union institution, agency or body;
2. Non-compliance with any of the prohibitions of the artificial intelligence practices referred 
to in Article 5 shall be subject to administrative fines of up to 500 000 EUR.
3. Non-compliance of the AI system with any requirements or obligations under this 
Regulation, other than those laid down in Articles 5 and 10, shall be subject to 
administrative fines of up to 250 000 EUR.
4. Before taking decisions pursuant to this Article, the European Data Protection Supervisor 
shall give the Union institution, agency or body which is the subject of the proceedings 
conducted by the European Data Protection Supervisor the opportunity of being heard on 
the matter regarding the possible infringement. The European Data Protection Supervisor 
shall base his or her decisions only on elements and circumstances on which the parties 
concerned have been able to comment. Complainants, if any, shall be associated closely 
with the proceedings.
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5. The rights of defense of the parties concerned shall be fully respected in the proceedings. 
They shall be entitled to have access to the European Data Protection Supervisor’s file, 
subject to the legitimate interest of individuals or undertakings in the protection of their 
personal data or business secrets.
6. Funds collected by imposition of fines in this Article shall be the income of the general 
budget of the Union.
TITLE XI
DELEGATION OF POWER AND COMMITTEE PROCEDURE
Article 73
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the 
conditions laid down in this Article.
2. The delegation of power referred to in Article 7(1), Article 7(3), Article 11(3), Article 
43(5) and (6) and Article 48(5) shall be conferred on the Commission for a period of five 
years from [entering into force of the Regulation].
The Commission shall draw up a report in respect of the delegation of power not later than 
nine months before the end of the 5 year period. The delegation of power shall be tacitly 
extended for periods of an identical duration, unless the European Parliament or the 
Council opposes such extension not later than three months before the end of each period.
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3. The delegation of power referred to in Article 7(1), Article 7(3), Article 11(3), Article 
43(5) and (6) and Article 48(5) may be revoked at any time by the European Parliament or 
by the Council. A decision of revocation shall put an end to the delegation of power 
specified in that decision. It shall take effect the day following that of its publication in the 
Official Journal of the European Union or at a later date specified therein. It shall not 
affect the validity of any delegated acts already in force.
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the 
European Parliament and to the Council.
5. Any delegated act adopted pursuant to Article 7(1), Article 7(3), Article 11(3), Article 
43(5) and (6) and Article 48(5) shall enter into force only if no objection has been 
expressed by either the European Parliament or the Council within a period of three 
months of notification of that act to the European Parliament and the Council or if, before 
the expiry of that period, the European Parliament and the Council have both informed the 
Commission that they will not object. That period shall be extended by three months at the 
initiative of the European Parliament or of the Council.
Article 74
Committee procedure
1. The Commission shall be assisted by a committee. That committee shall be a committee 
within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall 
apply.
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TITLE XII
FINAL PROVISIONS
Article 75
Amendment to Regulation (EC) No 300/2008
In Article 4(3) of Regulation (EC) No 300/2008, the following subparagraph is added:
“When adopting detailed measures related to technical specifications and procedures for approval 
and use of security equipment concerning Artificial Intelligence systems in the meaning of 
Regulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament and of the 
Council*, the requirements set out in Chapter 2, Title III of that Regulation shall be taken into 
account.”
__________
* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”
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Article 76
Amendment to Regulation (EU) No 167/2013
In Article 17(5) of Regulation (EU) No 167/2013, the following subparagraph is added:
“When adopting delegated acts pursuant to the first subparagraph concerning artificial intelligence 
systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial 
Intelligence] of the European Parliament and of the Council*, the requirements set out in Title III, 
Chapter 2 of that Regulation shall be taken into account.
__________
* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”
Article 77
Amendment to Regulation (EU) No 168/2013
In Article 22(5) of Regulation (EU) No 168/2013, the following subparagraph is added:
“When adopting delegated acts pursuant to the first subparagraph concerning Artificial Intelligence 
systems which are safety components in the meaning of Regulation (EU) YYY/XX on [Artificial 
Intelligence] of the European Parliament and of the Council*, the requirements set out in Title III, 
Chapter 2 of that Regulation shall be taken into account.
__________
* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”
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Article 78
Amendment to Directive 2014/90/EU
In Article 8 of Directive 2014/90/EU, the following paragraph is added:
“4. For Artificial Intelligence systems which are safety components in the meaning of Regulation 
(EU) YYY/XX [on Artificial Intelligence] of the European Parliament and of the Council*, when 
carrying out its activities pursuant to paragraph 1 and when adopting technical specifications and 
testing standards in accordance with paragraphs 2 and 3, the Commission shall take into account the 
requirements set out in Title III, Chapter 2 of that Regulation.
__________
* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”.
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Article 79
Amendment to Directive (EU) 2016/797
In Article 5 of Directive (EU) 2016/797, the following paragraph is added:
“12. When adopting delegated acts pursuant to paragraph 1 and implementing acts pursuant to 
paragraph 11 concerning Artificial Intelligence systems which are safety components in the 
meaning of Regulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament and 
of the Council*, the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into 
account.
__________
* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”.
Article 80
Amendment to Regulation (EU) 2018/858
In Article 5 of Regulation (EU) 2018/858 the following paragraph is added:
“4. When adopting delegated acts pursuant to paragraph 3 concerning Artificial Intelligence 
systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial 
Intelligence] of the European Parliament and of the Council *, the requirements set out in Title III, 
Chapter 2 of that Regulation shall be taken into account.
__________
* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”.
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Article 81
Amendment to Regulation (EU) 2018/1139
Regulation (EU) 2018/1139 is amended as follows:
(1) In Article 17, the following paragraph is added:
“3. Without prejudice to paragraph 2, when adopting implementing acts pursuant to paragraph 1 
concerning Artificial Intelligence systems which are safety components in the meaning of 
Regulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament and of the 
Council*, the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into 
account.
__________
* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”
(2) In Article 19, the following paragraph is added:
“4. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence 
systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial 
Intelligence], the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into 
account.”
(3) In Article 43, the following paragraph is added:
“4. When adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence 
systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial 
Intelligence], the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into 
account.”
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(4) In Article 47, the following paragraph is added:
“3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence 
systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial 
Intelligence], the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into 
account.”
(5) In Article 57, the following paragraph is added:
“When adopting those implementing acts concerning Artificial Intelligence systems which are 
safety components in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence], the 
requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.”
(6) In Article 58, the following paragraph is added:
“3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence 
systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial 
Intelligence] , the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into 
account.”.
Article 82
Amendment to Regulation (EU) 2019/2144
In Article 11 of Regulation (EU) 2019/2144, the following paragraph is added:
“3. When adopting the implementing acts pursuant to paragraph 2, concerning artificial intelligence 
systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial 
Intelligence] of the European Parliament and of the Council*, the requirements set out in Title III, 
Chapter 2 of that Regulation shall be taken into account.
__________
* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”.
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Article 83
AI systems already placed on the market or put into service
1. This Regulation shall not apply to the AI systems which are components of the large-scale 
IT systems established by the legal acts listed in Annex IX that have been placed on the 
market or put into service before [12 months after the date of application of this 
Regulation referred to in Article 85(2)], unless the replacement or amendment of those 
legal acts leads to a significant change in the design or intended purpose of the AI system 
or AI systems concerned.
The requirements laid down in this Regulation shall be taken into account, where 
applicable, in the evaluation of each large-scale IT systems established by the legal acts 
listed in Annex IX to be undertaken as provided for in those respective acts.
2. This Regulation shall apply to the high-risk AI systems, other than the ones referred to in 
paragraph 1, that have been placed on the market or put into service before [date of 
application of this Regulation referred to in Article 85(2)], only if, from that date, those 
systems are subject to significant changes in their design or intended purpose. 
Article 84
Evaluation and review
1. [deleted] 
1b. The Commission shall assess the need for amendment of the list in Annex III every 24 
months following the entry into force of this Regulation and until the end of the period of 
the delegation of power. The findings of that assessment shall be presented to the European 
Parliament and the Council.
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2. By [three years after the date of application of this Regulation referred to in Article 85(2)] 
and every four years thereafter, the Commission shall submit a report on the evaluation and 
review of this Regulation to the European Parliament and to the Council. The reports shall 
be made public. 
3. The reports referred to in paragraph 2 shall devote specific attention to the following:
(a) the status of the financial resources, technical equipment and human resources of the 
national competent authorities in order to effectively perform the tasks assigned to 
them under this Regulation;
(b) the state of penalties, and notably administrative fines as referred to in Article 71(1), 
applied by Member States to infringements of the provisions of this Regulation.
4. Within [three years after the date of application of this Regulation referred to in Article 
85(2)] and every four years thereafter, where appropriate, the Commission shall evaluate 
the impact and effectiveness of voluntary codes of conduct to foster the application of the 
requirements set out in Title III, Chapter 2 for AI systems other than high-risk AI systems
and possibly other additional requirements for AI systems, including as regards 
environmental sustainability. 
5. For the purpose of paragraphs 1a to 4 the Board, the Member States and national 
competent authorities shall provide the Commission with information on its request.
6. In carrying out the evaluations and reviews referred to in paragraphs 1a to 4 the 
Commission shall take into account the positions and findings of the Board, of the 
European Parliament, of the Council, and of other relevant bodies or sources.
7. The Commission shall, if necessary, submit appropriate proposals to amend this 
Regulation, in particular taking into account developments in technology and in the light of 
the state of progress in the information society.
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Article 85
Entry into force and application
1. This Regulation shall enter into force on the twentieth day following that of its publication 
in the Official Journal of the European Union.
2. This Regulation shall apply from [36 months following the entering into force of the 
Regulation].
3. By way of derogation from paragraph 2:
(a) Title III, Chapter 4 and Title VI shall apply from [twelve months following the 
entry into force of this Regulation];
(b) Article 71 shall apply from [twelve months following the entry into force of this 
Regulation].
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the European Parliament For the Council
The President The President
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ANNEX I
[deleted] 
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ANNEX II
LIST OF UNION HARMONISATION LEGISLATION
Section A – List of Union harmonisation legislation based on the New Legislative Framework
1. Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on 
machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24) [as repealed by 
the Machinery Regulation];
2. Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on 
the safety of toys (OJ L 170, 30.6.2009, p. 1);
3. Directive 2013/53/EU of the European Parliament and of the Council of 20 November 
2013 on recreational craft and personal watercraft and repealing Directive 94/25/EC (OJ L 
354, 28.12.2013, p. 90);
4. Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 
on the harmonisation of the laws of the Member States relating to lifts and safety 
components for lifts (OJ L 96, 29.3.2014, p. 251);
5. Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 
on the harmonisation of the laws of the Member States relating to equipment and 
protective systems intended for use in potentially explosive atmospheres (OJ L 96, 
29.3.2014, p. 309);
6. Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on 
the harmonisation of the laws of the Member States relating to the making available on the 
market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 
62);
7. Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on 
the harmonisation of the laws of the Member States relating to the making available on the 
market of pressure equipment (OJ L 189, 27.6.2014, p. 164);
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8. Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 
on cableway installations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1);
9. Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 
on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 
31.3.2016, p. 51);
10. Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 
on appliances burning gaseous fuels and repealing Directive 2009/142/EC (OJ L 81, 
31.3.2016, p. 99);
11. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 
on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and 
Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 
93/42/EEC (OJ L 117, 5.5.2017, p. 1;
12. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 
on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission 
Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
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Section B. List of other Union harmonisation legislation
1. Regulation (EC) No 300/2008 of the European Parliament and of the Council of 11 March 
2008 on common rules in the field of civil aviation security and repealing Regulation (EC) 
No 2320/2002 (OJ L 97, 9.4.2008, p. 72).
2. Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 
January 2013 on the approval and market surveillance of two- or three-wheel vehicles and 
quadricycles (OJ L 60, 2.3.2013, p. 52);
3. Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 
February 2013 on the approval and market surveillance of agricultural and forestry 
vehicles (OJ L 60, 2.3.2013, p. 1);
4. Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on 
marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 
146);
5. Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 
on the interoperability of the rail system within the European Union (OJ L 138, 26.5.2016, 
p. 44).
6. Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 
on the approval and market surveillance of motor vehicles and their trailers, and of 
systems, components and separate technical units intended for such vehicles, amending 
Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC 
(OJ L 151, 14.6.2018, p. 1); 
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7. Regulation (EU) 2019/2144 of the European Parliament and of the Council of 27 
November 2019 on type-approval requirements for motor vehicles and their trailers, and 
systems, components and separate technical units intended for such vehicles, as regards 
their general safety and the protection of vehicle occupants and vulnerable road users, 
amending Regulation (EU) 2018/858 of the European Parliament and of the Council and 
repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the 
European Parliament and of the Council and Commission Regulations (EC) No 631/2009, 
(EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) No 
1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU) No 458/2011, 
(EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No 
1230/2012 and (EU) 2015/166 (OJ L 325, 16.12.2019, p. 1);
8. Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 
on common rules in the field of civil aviation and establishing a European Union Aviation 
Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) 
No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the 
European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and 
(EC) No 216/2008 of the European Parliament and of the Council and Council Regulation 
(EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1), in so far as the design, production and 
placing on the market of aircrafts referred to in points (a) and (b) of Article 2(1) thereof, 
where it concerns unmanned aircraft and their engines, propellers, parts and equipment to 
control them remotely, are concerned.
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ANNEX III
HIGH-RISK AI SYSTEMS REFERRED TO IN ARTICLE 6(3)
In each of the areas listed under points 1-8, the AI systems specifically mentioned under each letter 
are considered to be high-risk AI systems pursuant to Article 6(3):
1. Biometrics:
(a) Remote biometric identification systems.
2. Critical infrastructure:
(a) AI systems intended to be used as safety components in the management and 
operation of critical digital infrastructure, road traffic and the supply of water, gas, 
heating and electricity.
3. Education and vocational training:
(a) AI systems intended to be used to determine access, admission or to assign natural 
persons to educational and vocational training institutions or programmes at all 
levels; 
(b) AI systems intended to be used to evaluate learning outcomes, including when those 
outcomes are used to steer the learning process of natural persons in educational and 
vocational training institutions or programmes at all levels.
4. Employment, workers management and access to self-employment:
(a) AI systems intended to be used for recruitment or selection of natural persons,
notably to place targeted job advertisements, to analyse and filter job applications, 
and to evaluate candidates; 
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(b) AI intended to be used to make decisions on promotion and termination of workrelated contractual relationships, to allocate tasks based on individual behavior or 
personal traits or characteristics and to monitor and evaluate performance and 
behavior of persons in such relationships.
5. Access to and enjoyment of essential private services and essential public services and 
benefits:
(a) AI systems intended to be used by public authorities or on behalf of public 
authorities to evaluate the eligibility of natural persons for essential public assistance 
benefits and services, as well as to grant, reduce, revoke, or reclaim such benefits and 
services;
(b) AI systems intended to be used to evaluate the creditworthiness of natural persons or 
establish their credit score, with the exception of AI systems put into service by 
providers that are micro and small-sized enterprises as defined in the Annex of 
Commission Recommendation 2003/361/EC for their own use;
(c) AI systems intended to be used to dispatch, or to establish priority in the dispatching 
of emergency first response services, including by firefighters and medical aid;
(d) AI systems intended to be used for risk assessment and pricing in relation to natural 
persons in the case of life and health insurance with the exception of AI systems put 
into service by providers that are micro and small-sized enterprises as defined in the 
Annex of Commission Recommendation 2003/361/EC for their own use.
6. Law enforcement:
(a) AI systems intended to be used by law enforcement authorities or on their behalf to 
assess the risk of a natural person for offending or reoffending or the risk for a 
natural person to become a potential victim of criminal offences;
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(b) AI systems intended to be used by law enforcement authorities or on their behalf as 
polygraphs and similar tools or to detect the emotional state of a natural person;
(c) [deleted] 
(d) AI systems intended to be used by law enforcement authorities or on their behalf to 
evaluate the reliability of evidence in the course of investigation or prosecution of 
criminal offences;
(e) AI systems intended to be used by law enforcement authorities or on their behalf to 
predict the occurrence or reoccurrence of an actual or potential criminal offence 
based on profiling of natural persons as referred to in Article 3(4) of Directive (EU) 
2016/680 or to assess personality traits and characteristics or past criminal behaviour 
of natural persons or groups;
(f) AI systems intended to be used by law enforcement authorities or on their behalf to 
profile natural persons as referred to in Article 3(4) of Directive (EU) 2016/680 in 
the course of detection, investigation or prosecution of criminal offences.
(g) [deleted] 
7. Migration, asylum and border control management:
(a) AI systems intended to be used by competent public authorities or on their behalf as 
polygraphs and similar tools or to detect the emotional state of a natural person;
(b) AI systems intended to be used by competent public authorities or on their behalf to 
assess a risk, including a security risk, a risk of irregular migration, or a health risk, 
posed by a natural person who intends to enter or has entered into the territory of a 
Member State; 
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(c) [deleted] 
(d) AI systems intended to be used by competent public authorities or on their behalf to 
examine applications for asylum, visa and residence permits and associated 
complaints with regard to the eligibility of the natural persons applying for a status.
8. Administration of justice and democratic processes:
(a) AI systems intended to be used by a judicial authority or on their behalf to interpret 
facts or the law and to apply the law to a concrete set of facts.
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ANNEX IV
TECHNICAL DOCUMENTATION referred to in Article 11(1)
The technical documentation referred to in Article 11(1) shall contain at least the following 
information, as applicable to the relevant AI system:
1. A general description of the AI system including:
(a) its intended purpose, the person/s developing the system the date and the version of 
the system;
(b) how the AI system interacts or can be used to interact with hardware or software that 
is not part of the AI system itself, where applicable;
(c) the versions of relevant software or firmware and any requirement related to version 
update;
(d) the description of all forms in which the AI system is placed on the market or put 
into service (e.g. software package embedded into hardware, downloadable, API 
etc.);
(e) the description of hardware on which the AI system is intended to run;
(f) where the AI system is a component of products, photographs or illustrations 
showing external features, marking and internal layout of those products;
(g) instructions of use for the user and, where applicable installation instructions;
2. A detailed description of the elements of the AI system and of the process for its 
development, including:
(a) the methods and steps performed for the development of the AI system, including, 
where relevant, recourse to pre-trained systems or tools provided by third parties and 
how these have been used, integrated or modified by the provider;
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(b) the design specifications of the system, namely the general logic of the AI system 
and of the algorithms; the key design choices including the rationale and assumptions 
made, also with regard to persons or groups of persons on which the system is 
intended to be used; the main classification choices; what the system is designed to 
optimise for and the relevance of the different parameters; the description of the 
expected output of the system; the decisions about any possible trade-off made 
regarding the technical solutions adopted to comply with the requirements set out in 
Title III, Chapter 2;
(c) the description of the system architecture explaining how software components build 
on or feed into each other and integrate into the overall processing; the computational 
resources used to develop, train, test and validate the AI system;
(d) where relevant, the data requirements in terms of datasheets describing the training 
methodologies and techniques and the training data sets used, including a general 
description of these data sets, information about their provenance, scope and main 
characteristics; how the data was obtained and selected; labelling procedures (e.g. for 
supervised learning), data cleaning methodologies (e.g. outliers detection);
(e) assessment of the human oversight measures needed in accordance with Article 14, 
including an assessment of the technical measures needed to facilitate the 
interpretation of the outputs of AI systems by the users, in accordance with Articles 
13(3)(d);
(f) where applicable, a detailed description of pre-determined changes to the AI system 
and its performance, together with all the relevant information related to the technical 
solutions adopted to ensure continuous compliance of the AI system with the 
relevant requirements set out in Title III, Chapter 2;
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(g) the validation and testing procedures used, including information about the validation 
and testing data used and their main characteristics; metrics used to measure 
accuracy, robustness, cybersecurity and compliance with other relevant requirements 
set out in Title III, Chapter 2 as well as potentially discriminatory impacts; test logs 
and all test reports dated and signed by the responsible persons, including with 
regard to pre-determined changes as referred to under point (f).
3. Detailed information about the monitoring, functioning and control of the AI system, in 
particular with regard to: its capabilities and limitations in performance, including the 
degrees of accuracy for specific persons or groups of persons on which the system is 
intended to be used and the overall expected level of accuracy in relation to its intended 
purpose; the foreseeable unintended outcomes and sources of risks to health and safety, 
fundamental rights and discrimination in view of the intended purpose of the AI system; 
the human oversight measures needed in accordance with Article 14, including the 
technical measures put in place to facilitate the interpretation of the outputs of AI systems 
by the users; specifications on input data, as appropriate;
4. A detailed description of the risk management system in accordance with Article 9;
5. A description of relevant changes made by the provider to the system through its lifecycle;
6. A list of the harmonised standards applied in full or in part the references of which have 
been published in the Official Journal of the European Union; where no such harmonised 
standards have been applied, a detailed description of the solutions adopted to meet the 
requirements set out in Title III, Chapter 2, including a list of other relevant standards and 
technical specifications applied;
7. A copy of the EU declaration of conformity;
8. A detailed description of the system in place to evaluate the AI system performance in the 
post-market phase in accordance with Article 61, including the post-market monitoring 
plan referred to in Article 61(3).
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ANNEX V
EU DECLARATION OF CONFORMITY
The EU declaration of conformity referred to in Article 48, shall contain all of the following 
information:
1. AI system name and type and any additional unambiguous reference allowing 
identification and traceability of the AI system;
2. Name and address of the provider or, where applicable, their authorised representative;
3. A statement that the EU declaration of conformity is issued under the sole responsibility of 
the provider;
4. A statement that the AI system in question is in conformity with this Regulation and, if 
applicable, with any other relevant Union legislation that provides for the issuing of an EU 
declaration of conformity;
5. References to any relevant harmonised standards used or any other common specification 
in relation to which conformity is declared;
6. Where applicable, the name and identification number of the notified body, a description 
of the conformity assessment procedure performed and identification of the certificate 
issued;
7. Place and date of issue of the declaration, name and function of the person who signed it as 
well as an indication for, and on behalf of whom, that person signed, signature.
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ANNEX VI
CONFORMITY ASSESSMENT PROCEDURE BASED ON INTERNAL CONTROL
1. The conformity assessment procedure based on internal control is the conformity 
assessment procedure based on points 2 to 4.
2. The provider verifies that the established quality management system is in compliance with 
the requirements of Article 17. 
3. The provider examines the information contained in the technical documentation in order 
to assess the compliance of the AI system with the relevant essential requirements set out 
in Title III, Chapter 2.
4. The provider also verifies that the design and development process of the AI system and its 
post-market monitoring as referred to in Article 61 is consistent with the technical 
documentation.
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ANNEX VII
CONFORMITY BASED ON ASSESSMENT OF QUALITY MANAGEMENT SYSTEM 
AND ASSESSMENT OF TECHNICAL DOCUMENTATION
1. Introduction
Conformity based on assessment of quality management system and assessment of the 
technical documentation is the conformity assessment procedure based on points 2 to 5. 
2. Overview
The approved quality management system for the design, development and testing of AI 
systems pursuant to Article 17 shall be examined in accordance with point 3 and shall be 
subject to surveillance as specified in point 5. The technical documentation of the AI 
system shall be examined in accordance with point 4.
3. Quality management system
3.1. The application of the provider shall include:
(a) the name and address of the provider and, if the application is lodged by the 
authorised representative, their name and address as well;
(b) the list of AI systems covered under the same quality management system;
(c) the technical documentation for each AI system covered under the same quality 
management system;
(d) the documentation concerning the quality management system which shall cover all 
the aspects listed under Article 17;
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(e) a description of the procedures in place to ensure that the quality management system 
remains adequate and effective;
(f) a written declaration that the same application has not been lodged with any other 
notified body.
3.2. The quality management system shall be assessed by the notified body, which shall 
determine whether it satisfies the requirements referred to in Article 17.
The decision shall be notified to the provider or its authorised representative.
The notification shall contain the conclusions of the assessment of the quality management 
system and the reasoned assessment decision.
3.3. The quality management system as approved shall continue to be implemented and 
maintained by the provider so that it remains adequate and efficient.
3.4. Any intended change to the approved quality management system or the list of AI systems 
covered by the latter shall be brought to the attention of the notified body by the provider.
The proposed changes shall be examined by the notified body, which shall decide whether 
the modified quality management system continues to satisfy the requirements referred to 
in point 3.2 or whether a reassessment is necessary.
The notified body shall notify the provider of its decision. The notification shall contain 
the conclusions of the examination of the changes and the reasoned assessment decision.
4. Control of the technical documentation.
4.1. In addition to the application referred to in point 3, an application with a notified body of 
their choice shall be lodged by the provider for the assessment of the technical 
documentation relating to the AI system which the provider intends to place on the market 
or put into service and which is covered by the quality management system referred to 
under point 3.
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4.2. The application shall include:
(a) the name and address of the provider;
(b) a written declaration that the same application has not been lodged with any other 
notified body;
(c) the technical documentation referred to in Annex IV.
4.3. The technical documentation shall be examined by the notified body. Where relevant and 
limited to what is necessary to fulfil their tasks, the notified body shall be granted full 
access to the training, validation, and testing datasets used, including, where appropriate 
and subject to security safeguards, through application programming interfaces (API) or 
other relevant technical means and tools enabling remote access.
4.4. In examining the technical documentation, the notified body may require that the provider 
supplies further evidence or carries out further tests so as to enable a proper assessment of 
conformity of the AI system with the requirements set out in Title III, Chapter 2. 
Whenever the notified body is not satisfied with the tests carried out by the provider, the 
notified body shall directly carry out adequate tests, as appropriate. 
4.5. Notified bodies shall be granted access to the source code of the AI system upon a 
reasoned request and only when the following cumulative conditions are fulfilled: 
a) Access to source code is necessary to assess the conformity of the high-risk AI system 
with the requirements set out in Title III, Chapter 2, and 
b) testing/auditing procedures and verifications based on the data and documentation 
provided by the provider have been exhausted or proved insufficient. 
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4.6. The decision shall be notified to the provider or its authorised representative. The 
notification shall contain the conclusions of the assessment of the technical documentation 
and the reasoned assessment decision.
Where the AI system is in conformity with the requirements set out in Title III, Chapter 2, 
an EU technical documentation assessment certificate shall be issued by the notified body. 
The certificate shall indicate the name and address of the provider, the conclusions of the 
examination, the conditions (if any) for its validity and the data necessary for the 
identification of the AI system.
The certificate and its annexes shall contain all relevant information to allow the 
conformity of the AI system to be evaluated, and to allow for control of the AI system 
while in use, where applicable.
Where the AI system is not in conformity with the requirements set out in Title III, Chapter 
2, the notified body shall refuse to issue an EU technical documentation assessment 
certificate and shall inform the applicant accordingly, giving detailed reasons for its 
refusal.
Where the AI system does not meet the requirement relating to the data used to train it, retraining of the AI system will be needed prior to the application for a new conformity 
assessment. In this case, the reasoned assessment decision of the notified body refusing to 
issue the EU technical documentation assessment certificate shall contain specific 
considerations on the quality data used to train the AI system, notably on the reasons for 
non-compliance.
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4.7. Any change to the AI system that could affect the compliance of the AI system with the 
requirements or its intended purpose shall be approved by the notified body which issued 
the EU technical documentation assessment certificate. The provider shall inform such 
notified body of its intention to introduce any of the above-mentioned changes or if it 
becomes otherwise aware of the occurrence of such changes. The intended changes shall 
be assessed by the notified body which shall decide whether those changes require a new 
conformity assessment in accordance with Article 43(4) or whether they could be 
addressed by means of a supplement to the EU technical documentation assessment 
certificate. In the latter case, the notified body shall assess the changes, notify the provider 
of its decision and, where the changes are approved, issue to the provider a supplement to 
the EU technical documentation assessment certificate.
5. Surveillance of the approved quality management system.
5.1. The purpose of the surveillance carried out by the notified body referred to in Point 3 is to 
make sure that the provider duly fulfils the terms and conditions of the approved quality 
management system.
5.2. For assessment purposes, the provider shall allow the notified body to access the premises 
where the design, development, testing of the AI systems is taking place. The provider 
shall further share with the notified body all necessary information.
5.3. The notified body shall carry out periodic audits to make sure that the provider maintains 
and applies the quality management system and shall provide the provider with an audit 
report. In the context of those audits, the notified body may carry out additional tests of the 
AI systems for which an EU technical documentation assessment certificate was issued.
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ANNEX VIII
INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF OPERATORS 
AND HIGH-RISK AI SYSTEMS IN ACCORDANCE WITH ARTICLE 51
Providers, authorised representatives and users that are public authorities, agencies or bodies shall 
submit the information referred to in Part I. Providers or, when applicable, authorised 
representatives shall ensure that the information on their high-risk AI systems referred to in Part II, 
1 to 11 is complete, correct and kept up-to-date. Information laid down in II.12 shall be 
automatically generated by the database.
Part I. Information related to operators (upon operators’registration)
-1. Type of operator (provider, authorised representative or user);
1. Name, address and contact details of the provider;
2. Where submission of information is carried out by another person on behalf of the 
operator, the name, address and contact details of that person;
Part II. Information related to the high-risk AI system
1. Name, address and contact details of the provider
2. Name, address and contact details of the authorised representative, where applicable;
3. AI system trade name and any additional unambiguous reference allowing identification 
and traceability of the AI system;
4. Description of the intended purpose of the AI system; 
5. Status of the AI system (on the market, or in service; no longer placed on the market/in 
service, recalled);
6. Type, number and expiry date of the certificate issued by the notified body and the name or 
identification number of that notified body, when applicable;
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7. A scanned copy of the certificate referred to in point 6, when applicable;
8. Member States in which the AI system is or has been placed on the market, put into service 
or made available in the Union;
9. A copy of the EU declaration of conformity referred to in Article 48;
10. Electronic instructions for use;
11. URL for additional information (optional).
12. Name, address and contact details of users
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ANNEX VIIIa
INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF HIGH-RISK AI 
SYSTEMS LISTED IN ANNEX III IN RELATION TO TESTING IN REAL WORLD CONDITIONS 
IN ACCORDANCE WITH ARTICLE 54a
The following information shall be provided and thereafter kept up to date with regard to testing in 
real world conditions to be registered in accordance with Article 54a:
1. Union-wide unique single identification number of the testing in real world conditions;
2. Name and contact details of the provider or prospective provider and users involved in the testing 
in real world conditions;
3. A brief description of the AI system, its intended purpose and other information necessary for the 
identification of the system;
4. A summary of the main characteristics of the plan for testing in real world conditions;
5. Information on the suspension or termination of the testing in real world conditions.
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ANNEX IX
UNION LEGISLATION ON LARGE-SCALE IT SYSTEMS IN THE AREA OF FREEDOM, 
SECURITY AND JUSTICE
1. Schengen Information System
(a) Regulation (EU) 2018/1860 of the European Parliament and of the Council of 28 
November 2018 on the use of the Schengen Information System for the return of 
illegally staying third-country nationals (OJ L 312, 7.12.2018, p. 1).
(b) Regulation (EU) 2018/1861 of the European Parliament and of the Council of 28 
November 2018 on the establishment, operation and use of the Schengen Information 
System (SIS) in the field of border checks, and amending the Convention 
implementing the Schengen Agreement, and amending and repealing Regulation 
(EC) No 1987/2006 (OJ L 312, 7.12.2018, p. 14)
(c) Regulation (EU) 2018/1862 of the European Parliament and of the Council of 28 
November 2018 on the establishment, operation and use of the Schengen Information 
System (SIS) in the field of police cooperation and judicial cooperation in criminal 
matters, amending and repealing Council Decision 2007/533/JHA, and repealing 
Regulation (EC) No 1986/2006 of the European Parliament and of the Council and 
Commission Decision 2010/261/EU (OJ L 312, 7.12.2018, p. 56).
2. Visa Information System
(a) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF 
THE COUNCIL amending Regulation (EC) No 767/2008, Regulation (EC) No 
810/2009, Regulation (EU) 2017/2226, Regulation (EU) 2016/399, Regulation 
XX/2018 [Interoperability Regulation], and Decision 2004/512/EC and repealing 
Council Decision 2008/633/JHA - COM(2018) 302 final. To be updated once the 
Regulation is adopted (April/May 2021) by the co-legislators.
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3. Eurodac
(a) Amended proposal for a REGULATION OF THE EUROPEAN PARLIAMENT 
AND OF THE COUNCIL on the establishment of 'Eurodac' for the comparison of 
biometric data for the effective application of Regulation (EU) XXX/XXX 
[Regulation on Asylum and Migration Management] and of Regulation (EU) 
XXX/XXX [Resettlement Regulation], for identifying an illegally staying thirdcountry national or stateless person and on requests for the comparison with Eurodac 
data by Member States' law enforcement authorities and Europol for law 
enforcement purposes and amending Regulations (EU) 2018/1240 and (EU) 
2019/818 – COM(2020) 614 final. 
4. Entry/Exit System
(a) Regulation (EU) 2017/2226 of the European Parliament and of the Council of 30 
November 2017 establishing an Entry/Exit System (EES) to register entry and exit 
data and refusal of entry data of third-country nationals crossing the external borders 
of the Member States and determining the conditions for access to the EES for law 
enforcement purposes, and amending the Convention implementing the Schengen 
Agreement and Regulations (EC) No 767/2008 and (EU) No 1077/2011 (OJ L 327, 
9.12.2017, p. 20).
5. European Travel Information and Authorisation System
(a) Regulation (EU) 2018/1240 of the European Parliament and of the Council of 12 
September 2018 establishing a European Travel Information and Authorisation 
System (ETIAS) and amending Regulations (EU) No 1077/2011, (EU) No 515/2014, 
(EU) 2016/399, (EU) 2016/1624 and (EU) 2017/2226 (OJ L 236, 19.9.2018, p. 1). 
(b) Regulation (EU) 2018/1241 of the European Parliament and of the Council of 12 
September 2018 amending Regulation (EU) 2016/794 for the purpose of establishing 
a European Travel Information and Authorisation System (ETIAS) (OJ L 236, 
19.9.2018, p. 72).
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6. European Criminal Records Information System on third-country nationals and stateless 
persons
(a) Regulation (EU) 2019/816 of the European Parliament and of the Council of 17 April 
2019 establishing a centralised system for the identification of Member States 
holding conviction information on third-country nationals and stateless persons 
(ECRIS-TCN) to supplement the European Criminal Records Information System 
and amending Regulation (EU) 2018/1726 (OJ L 135, 22.5.2019, p. 1). 
7. Interoperability 
(a) Regulation (EU) 2019/817 of the European Parliament and of the Council of 20 May 
2019 on establishing a framework for interoperability between EU information 
systems in the field of borders and visa (OJ L 135, 22.5.2019, p. 27).
(b) Regulation (EU) 2019/818 of the European Parliament and of the Council of 20 May 
2019 on establishing a framework for interoperability between EU information 
systems in the field of police and judicial cooperation, asylum and migration (OJ L 
135, 22.5.2019, p. 85).
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