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emdn_eudamed_nomenclature_en.pdf.txt | Medical Devices January 2020
DG Health and Food Safety
Directorate Health systems, medical products and innovation
Unit Medical Devices
Page 1 of 1
The European Medical Device Nomenclature (EMDN)
The European Medical Device Nomenclature (EMDN) will be the nomenclature of use by
manufacturers when registering their medical devices in the EUDAMED database.
Founded on pre-established criteria and requirements1 and based on orientations provided by
the Medical Device Coordination Group (MDCG) , the European Commission decided in
favour of the use of the ‘Classificazione Nazionale Dispositivi medici (CND)’2 as the basis
for the EMDN .
Currently, a n extrao rdinary revision of the CND is ongoing so that to release the first version
of the EMDN, which will be i ntegrated in EUDAMED for use by operators. The EMDN will
be fully available and accessible to any operators and will be copyright free.
To the extent possible, t he Commission will map the EMDN to the G lobal Medical Device
Nomenclature (GMDN) . This task has been undertaken with th e hopes of possibly facilitating
EMDN code search by operators current ly using GMDN . The correspondence between the
nomenclatures is intended to be visible to operators and incorporated in the future database in
the form of a searching tool. Therefore, and in cooperation with GMDN, t he mapping
exercise is currently ongoing . The level of quality and reliability of this mapping is dependent
on the commitment of all relevant parties to work together in ma pping and validating the
result s.
A sub -group of the MDCG on nomenclature which includes experts from National
Competent Authorities and stakeholders has been established to oversee regulatory activities
linked to nomenclature . The sub -group will aim to define the rules and processes related to
the creation, update , maintenance and use of the European Medical Device Nomenclature.
Additionally, t he Commission is currently collaborating with the World Health Organisation
(WHO ) in the context of their work and activities on a future international medic al device
nomenclature.
1 (MDCG 2018 -2) – Future EU medical device nomenclature: Description of requirements
2 CND is currently used in Italy, Portugal and Greece. |
FAQ_MDR_180117_V1.0-1.pdf.txt | Page 1 of 13
CAMD Transition Sub Group
FAQ – MDR Transitional provisions
Disclaimer :
The information presented in this document is for the purpose of general information only and is not intended to represent legal advice to any individual
or entity. It reflects the outcome of discussions within the Transition Sub Group (TSG) of the CAMD (established in May 2017) to establish
recommendations on the interpretation of transition -related provisions. It is not intended to be a guidance document . We recommend that you should
obtain your own legal advice before taking any action based on information given here. The content of this FAQ table will be updated cont inuously. While
we strive to provide the following information in as timely and accurate a manner as possible , this document does not make any claims or guarantees
about the accuracy, completeness or sufficiency of its contents. Participants of the Transit ion Sub Group, authors and reviewers of this document
expressly disclaim liability for any errors and omissions in the contents.
Page 2 of 13
Glossary:
• AIMDD/MDD compliant device = device that is compliant with Directive 90/385/EEC/ Directive 93/42/EEC
• AIMDD/MDD certificates = certificates in accordance with Directive 90/385/EEC/ Directive 93/42/EEC
• DoA = date of application of the MDR
• MDR = Medical Device Regulation (EU) 2017/745
• MDR compliant de vice = device that is compliant with the MDR
• MDCG = Medical Device Coordination Group
• MFR = manufacturer
• PRRC = person responsible for regulatory compliance
• NB = notified body
• “old” NB = NB that has issued an AIMDD/MDD certificate
• The Directives = Directives 90/385/EEC, 93/42/EEC
Document History
Version Publication Note
V1.0 17/01/18 Original publication
Conten ts:
I - Issue: Transition in general ................................ ................................ ................................ ................................ ................................ .............................. 3
II - Issue: Placing on the market of MDR compliant devices until 26 May 2020 (Art. 120 para 5 -7 MDR) ................................ ................................ ............. 4
III - Issue: Placing on the market of devices in conformity with the Directives after 26 May 2020 (Art. 120 para 2 -3 MDR) ................................ ................. 7
IV - Issue: The so called “sell off” provision of Art. 120 para 4 MDR ................................ ................................ ................................ ................................ .. 11
V – Issue: EUDAMED and its relevance for the application of certain provisions of the MDR (Art. 123 para 3 d and e, Art. 120 para 8, Art. 122 MDR) .... 12
Page 3 of 13
I - Issue: Transition in general
1 Question: When does the Medical Devices Regulation (EU) 2017/745 (= MDR) apply?
Answer: The MDR shall apply from 26 May 2020 (= date of application (DOA)) , see Art. 123 para 2 MDR .
There are however exceptions to that general rule. Some provisions apply earlier (e.g. regarding notified bodies or the
Medical Device Coordination Group), some later (e.g. regarding UDI labelling). For the exceptions, see Art. 123 para 3
MDR (earlier application: a -c, i; p ostponed application: d –h).
2 Question: When do the Directives 90/385/EEC , and 93/42/EEC [= the Directives] cease to apply ?
Answer: In general the Directives 90/385/EEC and 93/42/EEC are repealed with effect from 26 May 2020 (= DoA), see Art. 122
MDR . However there are some exceptions , e.g.
• in order to deal with devices that are compliant with the Directives or
• to serve as a “back up” in case EUDAMED is not fully functional at DoA
(see Art. 122 MDR).
3 Question: What is the applicable legislation until 26 May 2020 (= DoA )?
Answer: Laws and regulations adopted by Member States in accordance with the Directives (= Directives regime). There are
however exceptions (see for example Art. 123 para 3 a – c, i MDR and Art. 120 para 5 and 6 MDR ).
Page 4 of 13
II - Issue: Placing on the market of MDR compliant devices until 26 May 2020 (Art. 120
para 5 -7 MDR)
4 Question: Is it possible to place a device, which is compliant with the MDR (= MDR compliant
device ), on the market prior to 26 May 2020 (= DoA) ?
Answer: Yes, see Art. 120 para 5 MDR.
Manufacturer s (= MFR ) are – until 26 May 2020 (= DoA) normally required to place devices on the market that comply with
the Directives (= AIMDD/MDD compliant devices) , however Art. 120 para 5 MDR offers the option to place MDR compliant
devices on the market before DoA.
5 Question: Is it possible for all types of devices (for all different risk classes I – III) compliant with the MDR (= MDR compliant device)
to be placed on the market prior to 26 May 2020 (according to Art. 120 para 5 MDR )?
Answer: Yes, all types of devices - regardless of their risk class – may be placed on the market according to Art. 120 para 5 MDR.
This includes for example custom made devices (Art. 2 para 3 MDR ) and system s and procedure packs (Art. 2 para 10 and
para 11 MDR).
However , devices being subject to the “clinical evaluation consultation procedure” according to Art. 54 MDR (= certain
class III and class IIb devices) may not be placed on the market in ac cordance with Article 120 para 5 MDR before the
Medical Device Coordination Group ( MDCG ) and the expert panels have been established (see Art. 120 para 7 MDR) .
Depending on the risk class of the device, conformity assessment may requir e the involvement of a NB designated and
notified in accordance with the MDR (see Art. 120 para 6 MDR). In this c ase, such devices cannot complete a
conformity assessment, and therefore may not be placed on the market, before NBs have been designated and notified
under the MDR.
Page 5 of 13
6 Question: As a MFR , which obligations of the MDR do I need to fulfil in order to place a MDR compliant device on the market
before the DoA according to Art. 120 para 5 MDR?
Answer: As many obligations as are possible , while taking into account that
• EUDAMED is not fully functional and
• the MDR is not fully applicable
at that point in time .
Generally speaking, that is to say that:
• first, the device as such needs to be MDR compliant (see Annex I) and
• second, the MFR has to comply with the MDR.
In particular, the MFR shall undertake an assessment of the conformity of that device in accordance with the
applicable conformity assessment procedures set out in Art. 52 MDR . This may, depending on the risk class of the
devic e, necessitate the involvement of a notified body designated and notified in accordance with the MDR (see Art. 120
para 6 MDR).
The following requirements of the MDR need to be fulfilled by t he MFR (non -exhaustive list) :
• clinical evaluation
• risk management
• QMS
• Post-market surveillance
• Technical documentation and other reports
• Liability for defective devices
Page 6 of 13
However, exceptions /adaptations are possible /necessary , particularly due to the fact that EUDAMED may not be fully
functional before the DoA . For example :
• in the absence of a fully functional EUDAMED some requirements of the Directives shall – where necessary -
apply in place of the relevant provisions of the Regulation (e.g. registration of d evices and economic operators).
• A person responsi ble for regulatory compliance (PRRC, Art. 15 MDR) needs to be available but not
necessarily registered until EUDAMED is available . .
• The assignment of an UDI (Art. 27 para 3 MDR)
is not possible as long as there are
- no issuing entities designated by the Commission according to Art. 27 para 2 MDR or
- as long as the legal fiction according to Art. 120 para 12 does not apply (it shall apply from 26 May 2019 , see Art.
123 para 3 i MDR ).
It is of no significant use as long as there is no UDI database .
• An implant card and the information according to Art. 18 MDR need to be provided, however without the UDI
related content (as the requirement to place the UDI carrier on the devices will be stepwise introduced after the
DoA).
7 Question: Are MDR compliant devices placed on the market according to Art . 120 para 5 MDR subject to the so called “sell off”
provision in Art. 120 para 4 MDR (see below)?
Answer No, the possibility of their being made available/put into service is not time-limited.
Page 7 of 13
III - Issue: Placing on the market of devices in conformity with the Directives after 26
May 2020 (Art. 120 para 2 -3 MDR)
8 Question: Do certificates issued by notified bodies in accordance with the Directives (= AIMDD/MDD certificates ) prior to 25 May
2020 remain valid after the DoA?
Answer: Yes, as specified in Art. 120 para 2 MDR.
In general , they remain valid until the end of the period indicated on the certificate. Certain AIMDD/MDD certificates (Annex
4/IV, refer to Art. 120 para 2 first sentence MDR) become void at the latest on 27 May 2022, others (refer to Art. 120 para 2
second sentence MDR) on 27 May 2024 at the latest. In other words, after 27 May 2024 there will be no more valid
AIMDD/MDD certificates.
9 Question: What kind of certificates remain valid according to Art. 120 para 2 MDR?
Answer: All certificates which are commonly issued by Notified Bodies with reference to the Council Directives MDD and AIMDD.
That is [see for example NBOG BPG 2010 -3, similar NB-MED/2.5. 1Rec 4]:
EC Design -Examination Certificate
(Annex II section 4 MDD, Annex 2, section 4 AIMD)
Certificate of Conformity
(Annex IV MDD, Annex 4 AIMD)
EC Type Examination Certificate
(Annex III MDD; Annex 3 AIMD)
EC Certificate Full Quality Assurance System
(Annex II excluding section 4 MDD; Annex 2 section 2 AIMD)
EC Certificate Production Qualit y Assurance
(Annex V MDD, Annex 5 AIMD)
Page 8 of 13
EC Certificate Product Quality Assurance System
(Annex VI MDD)
10 Question: May a “ declaration of conformity ” be considered as a “certificate” according Art.120 para 2 MDR?
Answer: No, since it is not a certificate issued by a NB.
11 Question: Is it possible for a MFR to have valid MDR and valid AIMDD/MDD certificates in parallel until the 27 May 2024 expiry
date?
Answer: Yes.
12 Question: May devices, that are compliant with the Directives (= MDD/AIMDD compliant devices ), be placed on the market/put into
service after 26 May 2020 (= DoA) ?
Answer: Yes, under certain conditions (see answer on question 1 7) as specified in Art. 120 para 3 MDR.
In general , after 26 M ay 2020 , devices need to comply with the MDR in order to be placed on the market/put into service
(see Art. 5 MDR) . However , for a limited time (depending on the validity of the MDD/AIMDD certificates) there is the option
to continue to place devices on the market that are compliant with the Directives. Making use of this option may postpone
the immediate need for a new certificate under the MDR.
13 Question: May MFR s of class I devices , that are compliant with the Directives , make use of the derogation in Art. 120 para 3
MDR (= be placed on the market after the DoA)?
Answer: No, they must comply with the MDR , unless the device concerned is a class I device with measurement function or in
sterile condition covered by a valid MDD certificate .
Page 9 of 13
14 Question: May devices that are excluded from the scope of the MDR (e.g. via Art. 1 para 6 lit h) nonetheless benefit from Art. 120
para 3 MDR ?
Answer: No, these devices do not fall under the MDR, thus Art. 120 para 3 MDR is not applicable.
15 Question: May MDD/AIMDD compliant devices , which under the MDR will be subject to an “upgrade” in risk class (“up-
classification”) , e.g. formerly class IIa -> then class III , benefit from Art. 120 para 3 MDR ?
Answer: Yes, under the conditions specified in Art. 120 para 3 MDR (e.g. valid AIMDD/MDD certificate ). Devices which are in a
different respectively higher risk class in MDR than under the Directives are not as such excluded from the scope of Art.
120 para 3 MDR .
16 Question: If, according to Art. 120 para 3 MDR, a MFR intend s to place a MDD/ AIMDD compliant device on the market after the
DoA, that , under the MDR , will be subject to an “upgrade” in risk class (“up-classification”) , what is the relevant risk
class with regard to the applicable MDR requirements listed in Article 120 para 3 MDR (e.g. PSUR)?
Answer: The risk class under MDD/AIMDD .
17 Question: What are the requirements for the placing on the market/putting into service of MDD/AIMDD compliant devices
according to Art. 120 para 3 MDR after DoA?
Answer: See Art. 120 para 3 MDR.
In short:
1. A valid AIMDD/MDD certificate according to Art. 120 para 2 MDR
[All certificates necessary for the placing on the market of the device in question need to be valid , e.g. a class III
device needs to have a valid QMS as well as product specific certificate .]
2. Continuous compliance of the device with the Directives
Page 10 of 13
3. No signif icant changes in the design and intended purpose
[If there is a significant change in either the design or the intended purpose , Art. 120 para 3 MDR cannot be
claimed . Qualification of a change as “significant ” according to Art. 120 para 3 MDR shall be determined on a
case by case basis. However,
- limitations of the intended purpose
- design changes related to corrective actions assessed and accepted by the Competent Authority
are not considered “ significant ” in the sense of Art. 120 para 3 MDR. .
4. Appl ication of MDR requirements in place of the corresponding requirements of the Directives with regard to:
a. Registration of economic operators and of devices
(see Art. 31 MDR and Art. 29 MDR)
b. Post market surveillance (PMS)
(see Art. 83 -86, 92 MDR including Annex III but without the PMS having to be an integral part of the QMS)
c. Market surveillance
(see Art. 93 – 100 MDR, but device s tandards to be met = Directives )
d. Vigilance
(see Art - 87-92 MDR)
However exceptions are possible in the case that EUDAMED is no t fully functional in time (then see Art. 123
para 3 d and e MDR).
Moreover, the “old” NB which issued the AIMDD/MDD certificate shall continue to be responsible for the appropriate
surveillance of all the applicable requirements relating to the devices it has certified. This should be agreed on between the
“old” NB and the MFR on a contractual basis .
Page 11 of 13
IV - Issue: The so called “sell off” provision of Art. 120 para 4 MDR
18 Question: What is the so called “sell off” provision (Art. 120 para 4 MDR) about?
Answer: It is intended to limit the time during which AIMDD/MDD compliant devices, that have already been placed on the
market (either before the DoA or by virtue of Art. 120 para 3 after the DoA) , may be made available e.g. by a
distributor .
After May 27, 2025 these devices may not be made available/put into service (= deadline) . If such devices are still within
the supply chain by this date - i.e. have not reached the final user as being ready for use (e.g. the hospital) - they are not
“marketable” any more.
This provision is thus primarily dealing with the “making available” of AIMD/MDD compliant devices once they have
been placed on the market , e.g. within the supply chain . It does not apply to the “placing on the market” of these
devices by the MFR .
Please also note, that this provision is not intended to apply to second hand sales (see recital 3). This means , once a
device has been made available to the final use r (e.g. the hospital) as being ready for use, the further making available
of this device is not subject to/covered by the MDR.
19 Question: Does Art. 120 para 4 MDR enable MFRs to place MDD/AIMDD compliant devices on the market until May 27, 2025?
Answer: No. Art. 120 para 4 MDR is not applicable to the “placing on the marke t” of MDD/AIMDD compliant devices (see question
18). The only way to place MDD/AIMDD compliant devices on the market after DoA is Art. 120 para 3 MDR (see
question s 12-17). Given th at MDD/AIMDD certificate s will no longer be valid after May 27 2024 , this option ceases to
exist from that date onwards .
Page 12 of 13
V – Issue: EUDAMED and its relevance for the application of certain provisions of the MDR
(Art. 123 para 3 d and e, Art. 120 para 8, Art. 122 MDR)
20 Question: Do all devices have to be registered according to Art. 29 para 4 MDR by the DoA?
Answer: No. Even if EUDAMED is fully functional at the DoA there will be a n 18-month “interim phase ” (= EUDAMED fully
functional but Art. 29 para 4 MDR not yet applicable) during which the different devices to be placed on the market may
be registered “step by step” in EUDAMED accordin g to Art. 29 para 4 MDR instead of nationally according to the
Directives (see Art. 123 para 3 e and Art. 120 para 8 MDR) . However , at the end of this “interim phase ” it must be
ensured that all devices of a MFR’s portfolio have been registered in EUDAMED.
If EUDAMED is not fully functional until a date after the DoA, the 18 -month “interim phase” will be postponed accordingly
(beginning at the later of the dates referred to in point d) of Art. 123 para 3 MDR).
21 Question: Must NBs have entered all the certificate related information of all devices according to Art. 56 para 5 MDR into
EUDAMED by the DoA ?
Answer: No. Even if EUDAMED is fully functional at the DoA there will be an 18-month “interim phase” (= EUDAMED fully
functional but Art. 56 para 5 MDR not yet applicable) during which the relevant information according to Art. 56 para 5
MDR may be registered in EUDAMED “step by step = certificate by certificate” instead of nationally acco rding to the
Directives (see Art. 123 para 3 e and Art. 120 para 8 MDR). However , at the end of this “interim phase” it must be
ensured that all the relevant data regarding all certificates have been registered in EUDAMED.
If EUDAMED is not fully functio nal until a date after the DoA, the 18 -month “interim phase” will be postponed accordingly
(beginning at the later of the dates referred to in point d) of Art. 123 para 3 MDR).
Page 13 of 13
22 Question: What happens if EUDAMED is not fully functional at the DoA? How does this affect the application of obligations and
requirements of the MDR that relate to EUDAMED ?
Answer: The relevant provisions to refer to are mainly Art. 123 para 3 d and e .
Art. 123 para 3 d MDR:
The different Articles listed in Art. 123 para 3 d (= dealing with e.g. the registration of devices and economic operators,
clinical investigations, notified bodies, vigilance, post -market surveillance, market surveillance) are not fully postponed
with regard to their applicati on but generally remain applicable from the DoA. However , their application is postponed as
far as the obligations and requirements within these Articles relate to EUDAMED (which is not fully functional yet). To
that extent they shall apply from the date c orresponding to 6 months after the date of notice of full functionality .
Meanwhile ( until EUDAMED is fully functional ) the corresponding provisions of the Directives regarding exchange of
information continue to apply .
The principle is that the derogation applies to the electronic exchange of information/upload to EUDAMED. If the
derogation is applicable this does not necessarily mean that the information itself does not need to be
prepared/exchanged. This exchange of in formation e.g. reports will have to be done by other means in lieu of exchange
via EUDAMED (Directives regime ). The underlying idea behind this paragraph was to ensure compliance with the new
obligations and requirements via the “old” systems as far as pos sible.
The actual practical implication of this concept with regard to the different Articles listed in Art. 123 para 3 d MDR needs a
closer look and further guidance , which is in progress.
Art. 123 para 3 e MDR :
For the application of Art. 29 para 4 MDR and Art. 56 para 5 MDR in the case that EUDAMED is not fully functional in
time, see question 20 and 2 1. |
ivd_mfr_stepbystep.pdf.txt | MEDICAL DEVICES CHANGE OF LEGISLATION
Internal market,
Industry,
Entrepreneurship
and SMEs1STEP INTENTION / ACTION
Pre-assessmentBrief management to ensure a clear understanding of the importance and
business implications of the IVDR
Consider organisational challenges: management awareness, staffing capability
and availability, budget implications
GAP analysis and actions
resulting from thisAssess impact on products, internal resources, organisation and budget
Check new classification rules (IVDR Classes A–D) and confirm conformity assess -
ment routes for existing and future products. Check the requirement for involving the
Notified Bodies
Review the changes needed to existing technical documentation (Technical Files)
Review and upgrade quality management system (QMS) (point 3 below)
Check the adequacy of available clinical evidence and risk management and
identify any gaps (Article 56)
Review product labelling (Annex I Chapter III)
Ensure post-market surveillance (PMS) arrangements are adequate (Chapter VII
Section 1)
Prepare a post-market performance follow-up plan (PMPF, Annex XIII Part B)
Get ready for the new vigilance requirements (Chapter VII Section 2)
Ensure the respect of traceability obligations (Chapter III)
Quality Management
System (QMS)Review adequacy of QMS to meet standards and processes for IVDs under the
new Regulation
Build new regulatory requirements into the QMS
Identify/hire the person responsible for regulatory compliance within your
organisation (Article 15) and be sure it is adequately qualified and trained1
2
3What you need to know!Implementation Model for
In-Vitro Diagnostic Medical
Devices Regulation
Step by Step Guide
Ref. Ares(2018)3873813 - 20/07/20182Legal entitiesClarify how the company is affected: legal entities, obligation of economic
operators, organisational structures and resources
Consider organisational challenges: management awareness, staffing capability
and availability, budget implications
Ensure product liability insurance is adequate
PortfolioDo a cost/benefit analysis for your product portfolio; bear in mind costs related
to the new risk classification system and the need of involving a Notified Body
and costs for post-market surveillance and gaps in the technical documentation,
and plan your transition to the IVDR accordingly
Review supply chain provisions, and clarify roles and responsibilities of business
partners (authorised representatives, importers, distributors)
Master implementation
planBuild a roadmap for implementation, including definition of sub-projects, re -
source requirements and a steering group, and ensure overall responsibility for
IVDR implementation has been established
Give special consideration to certificate expiry dates, bearing in mind the transi -
tional period, transitional provisions and availability of your Notified Bodies
Notified BodiesContact the selected Notified Bodies and determine their capacity and
availability to service the implementation plan
Regulatory trainingEmpower and train staff through IVDR implementation and transition workshops
Execute master
implementation planImplement the various sub-projects (performance evaluation, technical
documentation, relations with other economic operators, Unique Device Identifica -
tion, labelling, post-market surveillance, vigilance, and reporting IT systems)
Ensure a cross-functional project management team is in place to cover all
aspects of implementation
Ensure overall and individual responsibilities for IVDR implementation have been
established
Review efficiency and
effectivenessImplement regular meetings on project status and progress, discrepancy and
gap analyses, risks, next steps and requirements
Hold regular progress reviews against the IVDR implementation plan and include
these in the management review process
Notified Body submissionDiscuss submission dates to avoid delays in the approval process
Ongoing monitoringActively monitor the still-developing European regulatory environment and
guidelines expected in the coming months (check DG GROW web pages on
medical devices and subscribe to the newsletter)
Establish a procedure for dealing with unannounced inspections from Notified Bodies
Regularly review the IVDR implementation plan, identifying and addressing key
areas of risk4
5
6
7
8
9
10
11
12
© European Union, [2018] Reuse is authorised provided the source is acknowledged.
The reuse policy of European Commission documents is regulated by Decision 2011/833/EU (OJ L 330, 14.12.2011, p. 39).
ISBN: 978-92-79-89124-3 DOI: 10.2873/41862
ET-04-18-659-EN-N |
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09 MDCG 2020-9 Regulatory Requirements for Ventilators and Reated Accessories.pdf.txt | "Medical Device \nMedical Device Coordination Group Document MDCG 2020-9 \n \n \n \n \n (...TRUNCATED) |
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Guidance-on-Article-15-MDR-IVDR-Person-responsible-for-Regulatory-Compliance.pdf.txt | "This document has been endorsed by the Medical Device Coordination Group (MDCG) \nestablished by Ar(...TRUNCATED) |
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