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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.  
  
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 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 
 
   
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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 ). 
   
   
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 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.  
    
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 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  
  
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 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.  
   
  
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 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)   
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  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 .  
    
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 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    
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 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 . 
   
 
   
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 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 .  
   
   
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 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).  
    
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 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.