G/TBT/W/654  
 
18 July 2019  
(19-4775) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
EUROPEAN UNION - MEDICAL DEVICE REGUL ATION (MDR) AND  
IN VITRO DIAGNOSTIC MEDICAL DEVICES REGU LATION (IVDR)  
STATEMENT BY THE EUROPEAN UNION TO THE COMMITTEE ON TECHNICAL BARRIERS T O TRADE  
20 AND 21 JUNE 2019  
The following communication, dated 17 July 2019, is being circulated at the request of the delegation 
of the European Union . 
 
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1.  The European Union thanks Delegation of the United States for its comments on the medical 
devices regulation (MDR) and in vitro diagnostic medical devices  regulation (IVDR).  
2.  The new MDR and IVDR were adopted in April 2017 and will enter into force in Ma y 2020 and in 
May 2022.  
3.  Compliance with these regulations will be essential for the general safety and performance of 
medical devices and will ensure that pace with technological progress is maintained.  
4.  The EU acknowledges that meeting the deadlines of May 2020 for medical devices and May 2022 
for in -vitro diagnostic medical devices (IVDs)  is a challenging task for the Commission, Member 
States and stakehold ers (notably Notified Bodies and operators), given the number and complexity 
of the new requirements.   
5.  The EU is also well aware that the timely availability of an appropriate number of Notified Bodies 
is one of the major and crucial challenges ahead.  
6.  For the time being, two Notified Bodies have been designated under the new MDR. These two 
are the two largest bodies in the EU, holding a significant share of the current certificates. Currently 
49 additional applications have been received by Commission s ervices, covering the full scope of the 
two Regulations, and 29 joint assessments have already been performed. Based on current 
information available, certain estimates indicate that approximately 20 Notified Bodies might be 
designated under the Medical De vices Regulations by the end of the year.  
7.  As one of the declared objectives of the new Regulation is to have in place a safer Notified Body 
infrastructure, the final number of Notified Bodies designated under the new Regulations will be 
slightly lower com pared to the current situation and it could take some time for many Notified Bodies 
to submit applications, depending on their level of preparedness.   
8.  However, we see that the number of applications has significantly increased over the last few 
months, cov ering almost all current existing Notified Bodies. We have also been informed that 
Notified Bodies have increased their resources by an average of 25 to 50 per cent for the assessment 
of medical devices and by up to 200 per cent for the assessment of IVDs.  New bodies have also 
made applications for designation under the Regulations.  
9.  The EU is committed to take steps to encourage Notified Bodies to make use of single audit 
reports of the Medical Device Single Audit Programme (MDSAP), in a manner that is com patible with 
EU legislative requirements. The EU is working on guidelines that are expected to be finalised before 
the end of the year.  G/TBT/W/654  
 
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  10.  The EU and the US will also cooperate to ensure the maximum possible alignment of electronic 
database specifications for  Unique Device Identifiers (a system based on a Unique Device Identifier 
code for facilitating the identification and traceability of devices). It is also agreed to develop a plan 
for bilateral compatibility tests of respective databases concerning Unique Device Identifiers.  
11.  Under the new MDR and IVDR, the Commission is requested to make available a medical device 
nomenclature to support the functioning of the future EU electronic database for medical devices 
Eudamed. As decided by the Commission and the Me dical Device Coordination Group (MDCG) the 
"free of charge " Nomenclature System for entering the data for medical devices into Eudamed will 
be the "Classificazione nazionale e internazionali " (CND). However, the CND nomenclature will be 
mapped to the GMDN nomenclature. The correspondence between the nomenclatures will be visible 
to operators and incorporated in the future database. This is intended to allow the EU and the US 
system to properly communicate.  
12.  Finally yet importantly, the new Regulations forese e some important transitional mechanisms, 
such as the possibility for manufacturers to continue to place products on the market under old 
Directive certificates until May 2024. This is an essential provision, which is applicable to a very 
significant porti on of medical devices currently available on the EU market.   
13.  In light of all these elements and taking also into account that the implementation activities are 
overall progressing according to plan, there are no grounds for the time being to explore any 
amendment to the transitional periods of the two Regulations. The EU is fully committed at this 
stage to ensure that the new system is introduced with no delay, to ensure a higher level of patient 
protection.  
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