19.9.2013 EN Official Journal of the European Union L 249/10 COMMISSION RECOMMENDATION of 17 September 2013 on the principles governing SOLVIT (Text with EEA relevance) (2013/461/EU) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 292 thereof, Whereas: (1) Article 26 of the TFEU defines the internal market as an area without internal borders in which the free movement of goods, persons, services and capital is ensured. Article 4, paragraph 3 of the TEU requires Member States to take any appropriate steps to comply fully with their obligations in accordance with Union law. (2) The internal market offers many opportunities to individuals who want to live and work in another Member State and to businesses that wish to expand their markets. While the internal market generally functions well, problems sometimes arise where public authorities do not respect Union law. (3) Following Commission Recommendation 2001/893/EC of 7 December 2001 on principles for using ‘SOLVIT’ – the Internal Market Problem Solving Network (1), SOLVIT was created as a network of centres set up by Member States within their own national administrations, as a fast and informal means of resolving problems individuals and businesses encounter when exercising their rights in the internal market. (4) Whilst SOLVIT is informal and pragmatic in nature, its set-up contributes to ensuring that solutions found are compliant with Union law. SOLVIT is based on a transparent problem-solving process involving two Member States. Whilst the Commission is not normally involved in resolving cases, it is in close contact with SOLVIT centres, offers regular legal training and, in some complex cases, provides informal advice. It also monitors SOLVIT case handling and outcomes via the online database and can intervene whenever it considers that solutions proposed by SOLVIT centres are not compliant with Union law. The aforementioned set-up not only contributes to the legality of outcomes in individual cases, but evaluation results indicate that the work of SOLVIT has also led to an overall improved compliance with Union law by national authorities. (5) SOLVIT has evolved significantly since its inception. It now handles ten times more cases than it did 10 years ago. It also handles a much wider variety of cases than originally foreseen. The overwhelming majority of cases are resolved successfully, within an average of nine weeks, leading to high satisfaction scores amongst those individuals and businesses that have used SOLVIT. (6) Whilst SOLVIT is a success, the increased scale of the service has amplified various challenges. An in-depth evaluation of the network carried out over 2010 indicates that not all SOLVIT centres are equally well resourced or positioned. The take-up of cases and the level of service offered also vary across the network. In addition, too few people and businesses find their way to SOLVIT. (7) Based on those findings, it is necessary to take measures to further reinforce SOLVIT and increase its visibility on and off line, as stressed in the Commission Staff Working Document ‘Reinforcing effective problem-solving in the Single Market’, in the Communication on Better Governance for the Single Market (2) and in the EU Citizenship Report (3). As a part of this exercise, Recommendation 2001/893/EC should be replaced by a new one. This new Recommendation aims to provide clarity on what SOLVIT should deliver, based on best practice. It sets out targets and standards for both Member States and the Commission to ensure that businesses and citizens receive effective assistance in those situations where Union law is not being respected. It also aims to guarantee that SOLVIT centres apply the same rules and deliver the same consistent type of service across the network. (8) In order to ensure a consistent interpretation of the mandate across the network, this Recommendation defines the types of cases that should be handled by SOLVIT. Recommendation 2001/893/EC stated that SOLVIT deals with cases of ‘misapplication’ of ‘single market rules’. Defining the scope in this way has led to inconsistency. First it has been argued that the term misapplication implies that SOLVIT centres cannot deal with cases where national rules run counter to Union law (so called ‘structural cases’), and second that SOLVIT can only act where the Union legislation in question has an internal market basis. (9) SOLVIT cases are now defined as all cross-border problems caused by a potential breach of Union law governing the internal market by a public authority, where and to the extent such problems are not subject to legal proceedings at either national or EU level. (10) The term ‘breach’ is used to specify that SOLVIT centres take on as a SOLVIT case all situations where public authorities do not respect Union law governing the internal market, regardless of the root cause of the problem. The overwhelming majority of cases handled by SOLVIT reflect situations wherein a public authority incorrectly applies Union law governing the internal market. However, SOLVIT centres have also shown to be able to offer effective help where structural problems arise. Although structural cases present only a small part of SOLVIT’s overall case load, the take-up of such cases by SOLVIT is important to ensure that such problems do not pass unnoticed. It offers the best guarantee that the structural problems are effectively tackled at the appropriate level. (11) This Recommendation confirms that SOLVIT deals with cases presenting a cross-border problem with a public authority. The cross-border criterion ensures that a SOLVIT case is handled by SOLVIT centres in two Member States, which guarantees transparency and quality of outcomes. The public authority criterion is linked to the fact that SOLVIT is part of the national administration and acts on an informal basis only. (12) This Recommendation also seeks to clarify the level of service individuals and businesses can expect from SOLVIT. It indicates how applicants should be informed and what minimum assistance they should be offered. It also clarifies the various procedural steps and deadlines to be respected when handling a SOLVIT case together with the follow-up to be given when a case cannot be resolved. (13) Further, this Recommendation sets out minimum standards SOLVIT centres should comply with, in terms of organisation, legal expertise, and relations with other networks. It also clarifies the role of the Commission within the SOLVIT network. (14) The Commission has recently rebuilt the SOLVIT online database as a stand-alone module in the Internal Market Information system. Given this technical integration, the rules set out in Regulation (EU) No 1024/2012 of the European Parliament and of the Council of 25 October 2012 on administrative cooperation through the Internal Market Information System and repealing Commission Decision 2008/49/EC (the ‘IMI Regulation’) (4) on the processing of personal data and of confidential information also apply to SOLVIT procedures. This Recommendation further specifies certain aspects of the processing of personal data in SOLVIT, in accordance with the IMI Regulation. (15) This Recommendation does not aim to specify how the Commission deals with complaints it receives directly and does not prejudice in any manner the Commission’s role as the guardian of the Treaties. It also does not aim to specify the role of EU Pilot and the national EU Pilot coordinators. These elements are addressed in specific guidelines, which are regularly updated. HAS ADOPTED THIS RECOMMENDATION: I. OBJECTIVE AND DEFINITIONS A. Objective This Recommendation sets out principles governing the functioning of SOLVIT. SOLVIT aims to deliver fast, effective and informal solutions to problems individuals and businesses encounter when their EU rights in the internal market are being denied by public authorities. It contributes to a better functioning single market by fostering and promoting better compliance with Union law. To achieve this purpose, national SOLVIT centres should work together on the basis of the principles set out in this Recommendation. B. Definitions For the purposes of this Recommendation the following definitions apply: 1. ‘Applicant’: a natural or legal person encountering a cross-border problem and submitting it to SOLVIT directly or through an intermediary, or an organisation submitting a concrete problem on behalf of its member(s); 2. ‘Cross-border problem’: a problem an applicant in one Member State encounters involving a potential breach of EU law governing the internal market by a public authority in another Member State; this includes problems caused to applicants by their own public administrations, after having exercised their free movement rights or when trying to do so; 3. ‘Union law governing the internal market’: any Union legislation, rules or principles related to the functioning of the internal market within the meaning of Article 26(2) TFEU. This includes rules that do not aim to regulate the internal market as such but have an impact on the free movement of goods, services, persons or capital between Member States; 4. ‘Public authority’: any part of the public administration of a Member State, at national, regional or local level, or any body, whatever its legal form, which has been made responsible, pursuant to a measure adopted by the State, for providing a public service under the control of the State and that has for that purpose special powers beyond those which result from the normal rules applicable in relations between individuals; 5. ‘Legal proceedings’: formal proceedings for the resolution of a dispute before a judicial or quasi-judicial body. This excludes administrative appeals against the same authority that has caused the problem; 6. ‘Structural problem’: a breach caused by a national rule running counter to Union law; 7. ‘Home Centre’: the SOLVIT centre in the Member State that has the closest links with the applicant based on for example nationality, residence, establishment or the place where the applicant acquired the rights at stake; 8. ‘Lead Centre’: the SOLVIT centre of the Member State in which the alleged breach of Union law governing the internal market has occurred; 9. ‘SOLVIT database’: the online application created within the Internal Market Information System (IMI) to support the handling of SOLVIT cases. II. MANDATE OF SOLVIT The SOLVIT network deals with cross-border problems caused by a potential breach of Union law governing the internal market by a public authority, where and to the extent such problems are not subject to legal proceedings at either national or Union level. It contributes to a better functioning single market by fostering and promoting better compliance with Union law. III. SERVICE OFFERED BY SOLVIT Member States should ensure that applicants can benefit from the following minimum service: 1. SOLVIT centres should be available by telephone or e-mail, and should provide a prompt reply to communications directed to them. 2. Applicants should receive within one week a first reaction to their problem, including an indication whether or not SOLVIT could take on their case, if such indication is possible on the basis of the information provided. If necessary, they should at the same time be invited to submit any documentation needed to process their file. Within one month after this first assessment and provided their file is complete, applicants should receive a confirmation of whether their case is accepted by the Lead centre and therefore opened as a SOLVIT case. 3. When a problem cannot be taken up as a SOLVIT case, applicants should be given reasons and be advised of another possible course of action that might help them overcome the problem, including signposting or transferring the problem, where possible, to another relevant information or problem-solving network or to the relevant national competent authority. 4. Within 10 weeks from the date of opening of the case, the applicant should receive a solution to its problem, which may include a clarification of the applicable Union law. In exceptional circumstances and in particular where a solution is close at hand or where it concerns a structural problem, the case can be kept open beyond the deadline, subject to informing the applicant, up to a maximum of 10 weeks. 5. Applicants should be informed about the informal nature of SOLVIT and the procedures and timeframes that apply. This information should include information about other possible means of redress, a warning that handling a case in SOLVIT does not put on hold national deadlines for appeal, and that solutions offered by SOLVIT are informal and cannot be appealed. Applicants should also be informed that SOLVIT is free of charge. Applicants should be regularly informed about the state of their case. 6. Whereas SOLVIT proceedings are of an informal nature, it does not preclude an applicant from launching formal proceedings at national level, which will result in closure of the SOLVIT case. 7. When a successful outcome has been found, the applicant should be advised on actions to take in order to benefit from the proposed solution. 8. As soon as it becomes apparent that a case will not be resolved within SOLVIT, the case should be closed and the applicant should be informed without delay. In such case, SOLVIT should also advise the applicant on other possible ways of redress at national or Union level. When advising complainants to file a complaint with the Commission, SOLVIT centres should encourage them to refer to prior proceedings in SOLVIT (by giving a reference number and shortly summarising these proceedings). Unresolved cases should be systematically reported to the Commission through the database. 9. After closing the case, applicants should be invited to give their feedback on how the case has been handled by SOLVIT. IV. ORGANISATION OF SOLVIT CENTRES 1. Each Member State should have a SOLVIT centre. 2. To secure that SOLVIT centres can fulfil the tasks set out in this Recommendation, Member States should ensure that SOLVIT centres: (a) have sufficient and well-trained staff with an operational knowledge of more than one Union language where needed to ensure fast and transparent communication with other SOLVIT centres; (b) have adequate legal expertise or relevant experience with the application of Union law in order to be able to make independent legal assessments of cases; (c) are situated in the part of the national administration with sufficient powers of coordination to be able to ensure the correct implementation of Union law within their administration; (d) are able to establish a network within the national administration in order to have access to the specific legal expertise and support needed in order to find practical solutions to cases. V. SOLVIT PROCEDURE A. Principles governing the handling of SOLVIT cases 1. All SOLVIT cases should be handled by two SOLVIT centres, the Home centre and the Lead centre. 2. The Home and Lead centres should cooperate in an open and transparent manner with a view to finding fast and effective solutions for applicants. 3. The Home and Lead centres should agree what language they use to communicate with each other, bearing in mind the aim of resolving the problems through informal contacts as quickly and efficiently as possible and ensuring transparency and reporting. 4. All problems received, the assessments done by the SOLVIT centres involved in the case, steps taken and outcomes proposed should be registered in the SOLVIT database in a clear and comprehensive manner. Where a case presents structural problems, it should be flagged as such in the database so as to enable the Commission to systematically monitor such cases. 5. All proposed solutions need to be always in full conformity with Union law. 6. SOLVIT centres should abide by the detailed case handling rules set out in SOLVIT’s case handling manual, which the Commission will regularly review in cooperation with the SOLVIT centres. B. Home centre 1. The Home centre should register all legal problems received, whether or not they qualify as a SOLVIT case. 2. Once the Home centre has accepted to take up a complaint as a SOLVIT case, it should constitute a complete file and carry out a comprehensive legal analysis of the problem before submitting it to the Lead centre. 3. When receiving a proposal for a solution from the Lead centre, including a clarification of the applicable Union law, it should check that the solution is in conformity with Union law. 4. The Home centre should provide the applicant with timely and appropriate information during the relevant steps of the procedure. C. Lead centre 1. The Lead centre should confirm acceptance of a case within one week after it is submitted by the Home centre. 2. The Lead centre should aim at finding solutions for applicants, including clarification of the applicable Union law and should regularly inform the Home centre about how it is progressing. 3. Where the problem submitted by the applicant is a structural problem, the Lead centre should assess as soon as possible whether the problem can be resolved through the SOLVIT procedure. If it considers that this is not possible, it should close the case as unresolved and inform the relevant national authorities responsible for the correct implementation of Union law in that Member State, so as to secure that the breach of Union law is effectively put to an end. The Commission should also be informed through the database. VI. ROLE OF THE COMMISSION 1. The Commission assists and supports the functioning of SOLVIT by: (a) organising regular training sessions and network events in cooperation with national SOLVIT centres; (b) drafting and updating the SOLVIT case-handling manual in cooperation with national SOLVIT centres; (c) providing case-handling assistance at the request of SOLVIT centres. In complex cases this may include providing informal legal advice. The Commission services should reply to requests for informal legal advice within two weeks. Such advice is informal only and cannot be considered as binding on the Commission; (d) managing and maintaining the SOLVIT database and a public interface and providing specific training and materials to facilitate its use by the SOLVIT centres; (e) monitoring the quality and performance of SOLVIT centres and the cases they handle. In cases presenting a structural problem, the Commission will closely monitor the case and, where needed, lend advice and assistance to ensure that the structural problem is put to an end. The Commission will consider whether unresolved structural problems require further follow-up; (f) securing appropriate communication between SOLVIT, CHAP (5) and EU Pilot (6) in order to ensure an appropriate follow up of unresolved SOLVIT cases, to monitor structural cases and to avoid duplication of the handling of complaints; (g) informing SOLVIT centres, at their request, about the follow-up given by the Commission to unresolved cases, where a complaint has been lodged with the Commission. 2. Where appropriate, the Commission may refer complaints it has received to SOLVIT with a view to finding a rapid and informal solution, subject to the consent of the complainant. VII. QUALITY CONTROL AND REPORTING 1. SOLVIT centres should conduct regular quality checks of cases they handle as Home centre and as Lead centre as detailed in the case handling manual. 2. The Commission services will conduct regular overall quality checks of all cases and signal possible problems to the SOLVIT centres concerned, which should take appropriate action to redress the shortcomings identified. 3. The Commission will regularly report on the quality and performance of SOLVIT. It will also report on the type of problems SOLVIT has received and cases handled within SOLVIT, with a view to defining trends and identifying remaining problems in the internal market. Within this reporting framework, the Commission will separately report on structural cases. VIII. VISIBILITY OF THE NETWORK 1. The Commission will promote the knowledge and use of SOLVIT with European stakeholder organisations and Union institutions and will improve the accessibility and presence of SOLVIT via on-line means. 2. Member States should ensure that user-friendly information and easy access to the SOLVIT services is available, in particular on all relevant websites of the public administration. 3. Member States should also undertake activities to raise awareness about SOLVIT amongst its stakeholders. The Commission will provide assistance to such activities. IX. COOPERATION WITH OTHER NETWORKS AND CONTACT POINTS 1. To ensure that applicants get effective help, SOLVIT centres should cooperate with other European and national information and help networks, such as Your Europe, Europe Direct, Your Europe Advice, the Enterprise Europe Network, European Consumer Centres, EURES, Fin-net and European Network of Ombudsmen. SOLVIT centres should also establish good working relationships with the respective national members of the Administrative Commission for the Coordination of Social Security, to enable an effective handling of social security cases. 2. SOLVIT centres should be in regular contact and cooperate closely with their national EU Pilot Contact Points, in order to secure a proper exchange of information on cases and complaints received. 3. The Commission will facilitate such cooperation by, among others, organising joint network events and establishing technical means of connection, with such networks and contact points as indicated in point 1 (7). X. PROTECTION OF PERSONAL DATA AND CONFIDENTIALITY The processing of personal data for the purposes of this Recommendation, including, in particular, transparency requirements and the rights of data subjects, is governed by the IMI Regulation. In line with that Regulation, the following should apply: 1. Applicants should be able to submit their complaints to SOLVIT through a public interface linked to the Internal Market Information System, put at their disposal by the Commission. Applicants do not have access to the SOLVIT database. 2. Home and Lead centres should have access to the SOLVIT database and be able to deal with the case they are involved in through this database. This includes access to personal data of the applicant. 3. Other SOLVIT centres not involved in a particular case and the Commission should have read-only access to anonymous information on the case. 4. The Home centre should normally disclose the applicant’s identity to the Lead centre to facilitate problem solving. The applicant should be informed of this at the start of the process and offered the opportunity to object, in which case the applicant’s identity should not be disclosed. 5. The information provided by the applicant should be used by the Lead centre and the public authorities concerned by the complaint only for the purpose of trying to resolve the case. Officials dealing with the case shall process the personal data only for the purposes for which they were transmitted. Appropriate steps should also be taken to safeguard commercially sensitive information not including personal data. 6. A case can be transferred to another problem-solving network or organisation only with consent of the applicant. 7. Staff of the Commission should only have access to personal data of applicants where this is necessary in order to: (a) avoid parallel treatment of the same problem submitted to the Commission or another Union institution by means of another procedure; (b) offer informal legal advice in accordance with Section VI; (c) decide on the possible follow-up to cases already handled by SOLVIT; (d) resolve technical issues affecting the SOLVIT database. 8. Personal data related to SOLVIT cases should be blocked in the Internal Market Information System 18 months after the closure of a SOLVIT case. Anonymised descriptions of SOLVIT cases should remain in the SOLVIT database and may be used for statistical, reporting and policy development purposes. XI. OTHER PROVISIONS This Recommendation replaces Recommendation 2001/893/EC. All references to Recommendation 2001/893/EC should be understood as references to this Recommendation. XII. DATE OF APPLICATION AND ADDRESSEES This Recommendation applies from 1 October 2013 This Recommendation is addressed to the Member States. Done at Brussels, 17 September 2013. For the Commission Michel BARNIER Member of the Commission (1) OJ L 331, 15.12.2001, p. 79. (2) COM(2012) 259 final. (3) COM(2013) 269 final. (4) OJ L 316, 14.11.2012, p. 1. (5) Complaint handling/Accueil des plaignants – Commission complaint registration system. (6) COM(2007) 502 final. (7) At the time of the adoption of this Recommendation the technical means are established with Your Europe Advice and are being developed with Europe Direct.

Summary: The principles governing SOLVIT, the problem-solving network for citizens and business The principles governing SOLVIT, the problem-solving network for citizens and business The SOLVIT network seeks to find solutions to complaints from EU citizens and businesses who suspect their EU rights have been breached by a public authority. ACT Commission Recommendation 2013/461/EU of 17 September 2013 on the principles governing SOLVIT. OJ L 249 of 19.9.2013. SUMMARY The Commission recommendation sets out the rules for cooperation between the SOLVIT centres. All EU Member States plus Norway, Iceland and Liechtenstein have created a national SOLVIT centre, in most cases within their prime minister's office or ministry of foreign or economic affairs. These centres cooperate directly via an online database to solve problems submitted by citizens and businesses pragmatically and within 10 weeks. The Commission is responsible for facilitating and coordinating the SOLVIT network. The service is free of charge and the solutions are not binding as it is an informal network. For SOLVIT to intervene there needs to be: a breach of EU law, by a public authority, in a cross-border situation. The applicant should not have started formal proceedings, as then it is no longer possible to find an informal solution to the problem. SOLVIT deals with problems in areas such as social security, residence rights, free movement of services and goods, recognition of professional qualifications, taxation and vehicle registration. The following is a brief summary of some examples of the services that the recommendation suggests that SOLVIT centres should offer (NB: readers wanting a full understanding of the principles should read the full recommendation). SOLVIT centres should be available by telephone or e-mail and should reply promptly to queries. Applicants should receive a first reaction to their problem within 1 week. Within 1 month of a first assessment and provided their file is complete, applicants should receive a confirmation of whether their case has been opened as a SOLVIT case. When a problem cannot be taken up as a SOLVIT case, applicants should be given reasons and advised of another possible course of action that might help them overcome the problem. Within 10 weeks from the date of opening of the case, the applicant should receive a solution to his/her problem, which may include a clarification of the relevant EU law. Visibility of the SOLVIT network The recommendation suggests that EU countries should ensure that user-friendly information and easy access to the SOLVIT services is available, in particular on all relevant websites of the public administration. It also urges EU countries to carry out activities to raise awareness about SOLVIT. REFERENCES Act Entry into force Deadline for transposition in the Member States Official Journal Recommendation 2013/461/EU - - OJ L 249 of 19.9.2013 Last updated: 22.04.2014


9.4.2013 EN Official Journal of the European Union L 99/17 COMMISSION RECOMMENDATION of 5 April 2013 on a common framework for a unique device identification system of medical devices in the Union (Text with EEA relevance) (2013/172/EU) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 292 thereof, Whereas: (1) Traceability of medical devices throughout the whole supply chain contributes to patient safety by facilitating vigilance, market surveillance and transparency in this sector. (2) The current regulatory framework for medical devices does not include specific provisions on traceability. Therefore, a recommendation paving the way to a reinforced regulatory approach on traceability of medical devices is needed. (3) The proposal from the European Commission for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 (1) adopted on 26 September 2012, and the proposal from the European Commission for a regulation of the European Parliament and of the Council on in vitro diagnostic medical devices (2) adopted on 26 September 2012, include provisions on traceability of medical devices and in vitro diagnostic medical devices, in order to improve patient health and safety. (4) The Council conclusions on innovation in the medical device sector (3) of 6 June 2011 invites the Commission and Member States to pay particular attention to interoperability and safety issues related to the integration of medical devices in e-Health systems, especially personal health systems. (5) Significant efforts are being made at international level towards a globally harmonised approach on traceability and to establish a globally accepted unique device identification (UDI) system for medical devices. (6) UDI mechanisms, based on different national and/or regional traceability requirements, have already been developed and there is a risk that further diverging UDI mechanisms may be developed at these levels. (7) In future certain information contained in the UDI code could feed the Electronic Health Record according to Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (4) and the Digital Agenda for Europe (5), HAS ADOPTED THIS RECOMMENDATION: 1. INTRODUCTION Purpose of the Recommendation 1. Traceability is currently not regulated by the medical device directives (6) while it is addressed in some cases at national and/or regional level. The differences and incompatibility between the traceability mechanisms may weaken and compromise the efficiency of the systems put in place. 2. In addition, the development of different national and/or regional unique device identification mechanisms would oblige manufacturers to adapt their products to each mechanism in order to fulfil traceability obligations. 3. The best way to ensure effective traceability of medical devices in the Union is to develop a UDI system harmonised at European level. The ongoing revision process of the current Directives on medical devices should empower the Commission to adopt detailed traceability requirements. 4. In the meantime, should Member States decide to develop their own UDI mechanisms it is essential that these are made compatible with each other and with the future UDI system of the Union. This is important in order to avoid the risk of incompatible and divergent systems frustrating the objectives of the internal market and to facilitate the introduction of a harmonized UDI system of the Union. 5. This Recommendation does not aim to define all the aspects of the UDI system. It should be taken as a tool to facilitate the compatibility of the traceability mechanisms established at national and/or regional level and to pave the way to the mandatory implementation of an internationally compatible UDI system of the Union. Scope of the Recommendation 6. This Recommendation applies to medical devices, active implantable medical devices (other than devices which are custom-made or intended for clinical investigations) and in vitro diagnostic medical devices (other than those manufactured in health institutions and for performance evaluation), including their accessories. International activity on UDI 7. At international level, in 2008 the Global Harmonization Task Force (GHTF) (7) set up an ad hoc working group with the purpose of developing an internationally coordinated approach on UDI. 8. This group, gathering industry and regulators, was chaired by the European Commission and ceased its activity in September 2011, when the GHTF adopted a guidance (8) document on a ‘Unique Device Identification (UDI) System for Medical Devices’. 9. The work of the GHTF towards a further harmonisation of the medical device regulatory framework is being carried out under the auspice of the International Medical Device Regulators Forum (IMDRF) (9). 10. This Recommendation is aligned to the approach developed at international level. European activity on UDI 11. In 2010, the European Commission set up a European UDI ad hoc Working Group, within the regulatory framework established by the directives on medical devices, in order to develop a coordinated approach, taking into account the progress made at both national and international level. 12. The aim of the group is threefold: (a) first, it is intended to encourage contributions and monitor the reaction of Competent Authorities to the work carried out at international level; (b) second, it encourages the sharing of views and information on national initiatives developed by Member States and search for common solutions; (c) thirdly, it facilitates the convergence with the future Union legislation of national initiatives developed by Member States. 2. RATIONALE 13. The primary objectives of a UDI system are patient safety (10) enhancement and patient care optimisation. It pursues these objectives by: (a) improving incident reporting; (b) facilitating efficient recalls and other field safety corrective actions (FSCA); (c) facilitating efficient post market actions by national competent authorities; (d) enabling queries in numerous data systems; (e) reducing the likelihood of medical errors linked to misuse of the device. 14. The establishment of a UDI system could also support the achievement of other objectives such as the fight against counterfeiting, better distribution control, stock management and reimbursement issues. 15. However, the objectives referred to in paragraph 14 should be seen as possible positive consequences of the UDI system. Improvement of incident reporting 16. The use of a UDI is expected to improve incident reporting and offers the opportunity to gather all the incidents related to one medical device at Union level and, in case of an internationally accepted and compatible UDI, at international level. This will increase the potential for comparing results associated with each specific medical device. Efficient recalls and other field safety corrective actions 17. The attribution of a unique identifier to a specific device and its use along the distribution chain (global use) will allow the unambiguous identification of the device itself. 18. For traceability to be ensured, it is not sufficient that every manufacturer has developed its own traceability mechanism. The lack of a Union system used all along the supply chain could lead to negative outcomes inasmuch as each actor of the distribution chain might modify the coding developed by the manufacturer. This might give rise to errors in the encoding of medical devices which would in turn endanger the traceability of devices in case of FSCA. The use of the same coding language improves the tracking and tracing of medical devices. Efficient post market actions by national competent authorities 19. A UDI system helps specifically to target identified products. 20. In addition, it will provide an opportunity to ensure coordinated reactions by Member States. Queries in numerous data systems 21. By using the same UDI in different data systems (both at regulatory and health institutions level) queries will become more efficient and it will be easier to perform searches in order to aggregate information. At the moment, this approach is not possible because each data system has its own identification tool. Reduction of medical errors 22. It might be expected that, by using identification mechanisms, the number of cases where medical devices have been incorrectly selected will be reduced. 3. DEFINITIONS For the purposes of this Recommendation the following definitions apply: (a) ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: — diagnosis, prevention, monitoring, treatment or alleviation of disease, — diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, — investigation, replacement or modification of the anatomy or of a physiological process, — control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means (11); (b) ‘active implantable medical device’ means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure (12); (c) ‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: — concerning a physiological or pathological state, or — concerning a congenital abnormality, or — to determine the safety and compatibility with potential recipients, or — to monitor therapeutic measures. Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination. Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination (13); (d) ‘traceability’ means the ability to trace the history, application or location of that which is under consideration; (e) ‘unique device identification — UDI’ means a series of numeric or alphanumeric characters that is created through an internationally accepted device identification and coding standard and allows the unambiguous identification of specific medical devices on the market. The UDI comprises the device identifier and production identifier; (f) ‘device identifier’ means a unique numeric or alphanumeric code specific to a manufacturer and a device model; (g) ‘production identifier’ means a unique numeric or alphanumeric code that identifies data related to the unit of device production; (h) ‘UDI carrier’ means the way in which the unique device identification is conveyed by means of the Automatic Identification and Data Capture (14) (AIDC) and, if applicable, its human readable interpretation (HRI); (i) ‘UDI electronic system’ means a central repository/database storing device identifier codes and related/associated identifying information of specific devices placed on the Union market; (j) ‘human readable interpretation’ means a legible format of the data characters encoded in the AIDC symbol; (k) ‘direct part mark’ means any technology which can be used to fix a symbol on the surface of an item (e.g. producing two different surface conditions by laser etching, moulding, peening or other technologies like ink jet printing or flexography); (l) ‘manufacturer’ means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party (15); (m) ‘authorised representative’ means any natural or legal person established within the Union who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under the relevant Community legislation (16); (n) ‘importer’ means any natural or legal person established within the Union who places a device from a third country on the Union market (17); (o) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a device available on the market (18); (p) ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor (19); (q) ‘health institution’ means an organisation whose primary purpose is the care or treatment of patients and/or the promotion of public health; (r) ‘user’ means the person, either professional or lay, who uses a device. 4. RISK BASED APPROACH 23. Should Member States intend to establish a UDI system they should follow a risk based approach in accordance with the classification of the device. 24. The UDI system should be implemented gradually, starting from highest risk class devices which should be the first to respect the condition to bear the UDI. UDI type 25. The UDI should comprise two parts, a device identifier and a production identifier. 26. The device identifier should contain static information (20) specific to a manufacturer and a device model and is also used as the ‘access key’ to information stored in a UDI database. 27. The production identifier should contain dynamic information (21) identifying data related to the unit of device production and determine the level of traceability to be achieved. 28. UDI should appear in both human readable format (human readable version composed of a series of numeric or alphanumeric characters) and in a format that can be read by an AIDC technology and conveyed via a carrier. 29. If there are significant constraints limiting the use of both AIDC and HRI on the label, the AIDC format should be favoured. However, certain environments or use situations, such as home care, may warrant the use of HRI over AIDC. 30. Member States should monitor that differentiation between the different classes of devices is based exclusively on the type of production identifier (dynamic information) in accordance with paragraph 31. 31. As a general rule, the information provided by the production identifier (dynamic information) should vary according to the different risk classes as follows (22): — expiration date and/or manufacturing date for class I, — lot/batch number for class IIa, — lot/batch number for class IIb, — lot/batch number or serial number (23) for class III. 32. Where appropriate, manufacturers may choose a production identifier (dynamic information) applicable to a higher class than the device in question. UDI application 33. As a general rule, UDI should be applied to every packaging level for all classes of devices (24). 34. UDI carrier (AIDC and HRI representation of the UDI) should be on the label of the device, its package, or on the device itself (direct part mark), and on all higher levels of packaging (25). 5. CONDITIONS TO BE FULFILLED BY ECONOMIC OPERATORS, HEALTH INSTITUTIONS AND PROFESSIONAL USERS 35. In order to achieve the objectives of the UDI system, while developing their own national UDI mechanisms, the economic operators and health institutions should store through the distribution chain information related to both the device identifier (static information) and the production identifier (dynamic information). Health institutions and, where feasible, professional users should use this information in their reporting of incidents. This will, in particular, allow a more efficient action in case of recall or withdrawal of products. 36. Information related to the device identifier (static information) should be collected into the national UDI databases. 37. Once the future European databank on medical devices (Eudamed) is established, information related to device identifier (static information) will be centralised at European level via a European UDI electronic system which will be part of the future Eudamed. 38. As regards information related to production identifier (dynamic information), it should not be sent to the national UDI databases and will not be included in the European UDI electronic system. For the purpose of this Recommendation economic operators, health institutions and professional users should align with the following conditions. Manufacturers 39. First, manufacturers should appropriately allocate a UDI (static and dynamic parts) to the medical devices they manufacture. 40. Second, they should provide the required data elements (see Annex) to be included in the UDI database. 41. Third, they should modify the labelling of their products in order to print the UDI code as far as practicable on the label of the device, its package, or on the device itself (direct part mark), and on all higher levels of packaging, as referred to in paragraph 34. 42. Fourth, they should keep an electronic record of both device identifier (static information) and production identifier (dynamic information). 43. Lastly, they should keep an electronic record of the economic operator, health institution or professional users to whom they have supplied each specific product. Importers 44. First, importers should verify that the manufacturer has appropriately allocated a UDI (static and dynamic parts) to the product before they put it on the Union market. Where an importer considers or has reason to believe that this condition has not been fulfilled, he should not place the device on the Union market until it is brought into conformity. 45. Second, importers should not remove or modify the UDI, otherwise traceability will be impossible. 46. Third, they should ascertain whether the device has already been registered in the UDI database of the Member State where the device has been placed on the Union market. 47. If the device has already been registered, importers should verify that the device identifier (static information) on the product corresponds to that in the UDI database. 48. If the device has not yet been registered, the importers should align with the conditions concerning the registration of the information related to the device identifier (static information). 49. Fourth, they should keep an electronic record of both device identifier (static information) and production identifier (dynamic information). 50. Fifth, they should keep an electronic record of the economic operator who has supplied them with a device. 51. Lastly, they should keep electronic record of the economic operator, health institution or professional users to whom they have supplied the device. Authorised representatives 52. Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he should designate a single authorised representative in the Union. The designation must be effective at least for all devices of the same model. 53. The authorised representatives should have access, on request, to the record of both device identifier (static information) and production identifier (dynamic information) related to the product(s) for which he is appointed. Distributors 54. First, before making a device available on the market distributors should verify that the manufacturer and, where applicable, the importer has appropriately allocated a UDI (static and dynamic parts) to the product. Where a distributor considers or has reason to believe that this condition has not been fulfilled, he should not make the device available on the Union market until it is brought into conformity. 55. Second, distributors should not remove or modify the UDI, otherwise traceability will be impossible. 56. Third, they should keep an electronic record of both device identifier (static information) and production identifier (dynamic information). 57. Fourth, they should keep an electronic record of the economic operator who has supplied them with a device. 58. Lastly, they should keep an electronic record of the economic operator, health institution or professional users to whom they have supplied a device. Health institutions 59. First, health institutions should keep an electronic record of both device identifier (static information) and production identifier (dynamic information) of medical devices entering these organisations. Information related to both device identifier (static information) and production identifier (dynamic information) in respect of devices for which incidents are reported should be used by health institutions in their reporting of incidents. 60. Second, for certain medical devices, such as those used for high risk procedures and/or specifically intended to be used for high risk patients, a link should be established between the device used and the patient treated with it. Therefore, health institutions should keep a record of which device has been used on which patient. 61. Third, for certain devices such as implantable medical devices, health institutions should store both device identifier (static information) and production identifier (dynamic information) in the electronic patient record. Indeed, in case of recall, it should be possible to know exactly which medical device has been implanted to which patient. Professional users 62. Where feasible, information related to both device identifier (static information) and production identifier (dynamic information) in respect of devices for which incidents are reported should be used by professional users in their reporting of incidents. 6. UDI NATIONAL DATABASES Data elements 63. Member States who intend to establish a UDI system for medical devices are invited to build it on national UDI databases. 64. For the purpose of this Recommendation, Member States are invited to promote the use of the Extensible Markup Language (XML), as a common format for data exchange between UDI databases, and take into account relevant specifications and semantic standards existing in the area. 65. The data elements, which are listed in the Annex, should be introduced in UDI national databases and should correspond to the elements linked to the device identifier (static information). Done at Brussels, 5 April 2013. For the Commission Tonio BORG Member of the Commission (1) COM(2012) 542 final (2) COM(2012) 541 final. (3) OJ C 202, 8.7.2011, p. 7. (4) OJ L 88, 4.4.2011, p. 45. (5) http://ec.europa.eu/digital-agenda/ (6) Council Directive 90/385/EEC (OJ L 189, 20.7.1990, p. 17), Council Directive 93/42/EEC (OJ L 169, 12.7.1993, p. 1), Directive 98/79/EC of the European Parliament and of the Council (OJ L 331, 7.12.1998, p. 1). (7) The ‘Global Harmonization Task Force (GHTF)’ is a voluntary international group of representatives from medical device regulatory authorities and trade associations from Europe, the United States of America (USA), Canada, Japan and Australia. GHTF was conceived in 1992 in an effort to respond to the growing need for international harmonisation in the regulation of medical devices. The GHTF mission ended in December 2012. (8) www.imdrf.org/docs/ghtf/final/steering-committee/technical-docs/ghtf-sc-n2r3-2011-unique-device-identification-system-110916.pdf (9) The ‘International Medical Device Regulators Forum (IMDRF)’ was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonisation. It is a voluntary group of medical device regulators from Australia, Brazil, Canada, China (observer), European Union, Japan, Russia (observer) and the United States who have come together to build on the strong foundational work of the ‘Global Harmonization Task Force on Medical Devices (GHTF)’. The ‘World Health Organization (WHO)’ participates in the IMDRF as an observer. (10) Patient safety is understood as the avoidance, prevention and amelioration of adverse outcomes or injuries stemming from the processes of health care. These events include ‘errors’, ‘deviations’, ‘accidents’. Safety emerges from the interaction of the components of the system; it does not reside in a person, device or department. Improving safety depends on learning how safety emerges from the interactions of the components. Patient safety is a subset of health care quality. (11) Article 1(2)(a) of Directive 93/42/EEC. (12) Article 1(2)(c) of Directive 90/385/EEC. (13) Article 1(2)(b) of Directive 98/79/EC. (14) The Automatic Identification and Data Capture refers to the methods for automatically identifying objects, collecting data about them, and entering the data directly into computer systems. (15) Article 1(2)(f) of Directive 93/42/EEC. (16) Article 1(2)(j) of Directive 93/42/EEC. (17) Article 2(5) of Regulation (EC) No 765/2008 of the European Parliament and of the Council (OJ L 218, 13.8.2008, p.30). (18) Article 2(6) of Regulation (EC) No 765/2008. (19) Article 2(7) of Regulation (EC) No 765/2008. (20) This information does not vary from one to another device of the same specific model. (21) This information varies according to the different way the production process is controlled (by expiration/manufacturing date, lot/batch number or serial number). (22) In accordance with international guidance, possible exceptions and/or exemptions to the general rule, based on the device class, should be taken into account. (23) The serial number allows the identification of the individual device unit. (24) In accordance with international guidance, possible exceptions and/or exemptions to the general rule, based on the device class, should be taken into account. (25) According to international guidance, pallets are not included in the notion of higher levels of packaging therefore UDI conditions do not apply to pallets. ANNEX DATA ELEMENTS OF THE NATIONAL UDI DATABASES National databases on UDI should include the following data elements: (a) quantity per package configuration; (b) if applicable, alternative or additional identifier(s); (c) the way how the device production is controlled (expiration date or manufacturing date, lot or batch number, serialisation number); (d) if applicable, the unit of use device identifier (when a UDI is not assigned to the device at the level of its unit of use, a ‘unit of use’ device identifier shall be assigned to associate the use of a device with a patient); (e) name and address of the manufacturer (as indicated on the label); (f) if applicable, name and address of the authorised representative (as indicated on the label); (g) Global Medical Device Nomenclature (GMDN) code or internationally recognised nomenclature code; (h) if applicable, trade/brand name; (i) if applicable, device model, reference, or catalogue number; (j) if applicable, clinical size (including volume, length, gauge and diameter); (k) additional product description (optional); (l) if applicable, storage and/or handling conditions (as indicated on the label or in the instructions for use); (m) if applicable, additional trade names of the device; (n) labelled as single use device (y/n); (o) if applicable, restricted number of reuses; (p) device packaged sterile (y/n); (q) need for sterilisation before use (y/n); (r) labelled as containing latex (y/n); (s) labelled as containing DEPH (y/n); (t) URL for additional information, e.g. electronic instructions for use (optional); (u) if applicable, critical warnings or contraindications.

Summary: EU system to identify medical devices for greater patient safety EU system to identify medical devices for greater patient safety The recommendation to European Union (EU) governments is designed to improve patient safety by using a common framework to identify medical devices so they can be easily traced. ACT Commission Recommendation 2013/172/EU of 5 April 2013 on a common framework for a unique device identification system of medical devices in the Union (Official Journal L 99 of 9.4.2013). SUMMARY Medical devices range from simple bandages to breast implants and highly sophisticated life-support machines. Legislation exists to guarantee the health and safety of patients and professionals who use them, but this does not include ways of tracing the items during their life cycle. Common identification system (Unique Device Identification - UDI) A common system has many advantages. It makes it possible to identify the products involved in any incident and arrange their recall, if necessary. Using the same data, such as a manufacturer's name and batch number, will enable this to be achieved across the EU, not just in one country. It should reduce medical errors where a device has been incorrectly used. Benefits The primary aim of the UDI system is to increase patient safety. It will also make it easier to identify fake products, improve distribution control and stock management of the items involved and accurately identify the devices used when treatment is reimbursed. Efforts are under way to establish a globally accepted UDI system to replace different national and regional ones used in the EU. A single European UDI system will avoid unnecessary complications for manufacturers and users in the EU and will be aligned with international standards. Requirements on manufacturers Manufacturers must clearly identify the medical devices they produce with a UDI label or mark. The UDI will include an expiry or manufacturing date and a batch number. Importers and distributors must verify that this has been done before offering the equipment for sale. Requirements on health institutions Hospitals and other health institutions should keep an electronic record of the medical devices on their premises and when these are used for high-risk operations include information on which device has been used on which patient. Centralised databank on medical devices Information on manufacturers and the devices they produce will be centralised in the future European databank on medical devices (Eudamed) once it is established. Last updated: 23.07.2014