G/TBT/W/683  
 
25 November 2019  
(19-7999) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
 EUROPEAN UNION – MEDICAL DEVICES REGULAT ION (MDR) AND IN VIT RO 
DIAGNOSTIC MEDICAL D EVICES REGULATION  (IVDR)  
STATEMENT BY THE EUROPEAN UNION TO THE COMMITTEE ON TECHNICAL BARRIERS T O TRADE  
13 – 15 NOVEMBER  2019 
The following communication, dated 13 November  2019, is being circulated at the request of the 
delegation of the European Union . 
 
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1.  Thank you to the delegations of Japan, China, the United States, the Republic of Korea, Canada 
and Mexico fo r their 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 Mar ch 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 diagn ostic medical devices (IVDs) is a challenging task for the Commission, Member 
States and stakeholders (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, seven Notified Bodies have been designated under the new MDR and two 
under the IVDR. Currently 51 additional applications have been received by Commission services, 
covering the full scope of the two Regulations, and 29 joint assessments have already been 
performed. Based on current information available, estimates indicate that approximately 20 Notified 
Bodies might be designated under the Med ical Devices 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 lo wer compared to the current situation and it could take some time for many Notified Bodies 
to submit applications, depending on their level of preparedness.  
8.   The applications cover a vast majority of the current existing Notified Bodies. We have also been  
informed that Notified Bodies have increased their resources by an average of 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 Regulati ons.  
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 compatible with 
EU legislative requirements. The EU is working on guidelines that are expected to be finalised early 
next year.  G/TBT/W/683  
 
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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 fac ilitating 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 a vailable 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 Medical Device Coordination Group (MDCG) the 
'free of charge' Nomenclature System for e ntering 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 operato rs 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 foresee 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 portion of medical devices currently available on the EU market. Discussions on a 
Corrige ndum that would extend these provisions further to a number of upgraded class I devices 
are currently ongoing in Council and Parliament. If adopted, this Corrigendum would alleviate the 
current workload of Notified Bodies.  
13.  In light of all these elements an d 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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