G/TBT/W/734  
 
13 March 2020 
(20-2013) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
EUROPEAN UNION - MEDICAL DEVICE REGULATI ON (MDR) AND  
IN VITRO DIAGNOSTIC MEDICAL DEVICES REGU LATION (IVDR)  
STATEMENT BY THE UNITED STATES  TO THE COMMITTEE ON TECHNICAL BARRIERS T O TRADE  
26 – 27 FEBRUARY  2020 
The following communication, dated 12 March  2020, is being circulated at the request of the 
delegation of the United States . 
 
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1.  The United States supports the development and enforcement of a well -defined medical device 
regulatory system th at assures the safety and performance of medical devices. However, we have 
serious concerns regarding the implementation of the MDR and IVDR , and our industry  remains  
worried about its continued access to the EU 's USD 125 billion medical device market, USD 20 billion 
of which is supplied by U.S. products.  
2.  MDR/IVDR 's implementation remains  behind schedule. Our industry has two main concerns.  
3.  First, there is an insufficient number of n otified bodies designated to perfor m certification 
activities under the MDR/IVDR.  
• With only ten discrete Notified Bodies currently designated - 11 for MDR and 3 for IVDR - 
can the EU provide an estimate as to when all notified bodies are expected to be 
operational?  
• In November, the EU exp ressed confidence that 20 notified bodies would be certified by 
the end of 2019, although there could be some delay of notification in the NANDO 
database. Even if 20 notified bodies had been certified in the timeframe indicated, this 
number would still be insufficient to ensure continued regulatory approvals by May 2020. 
Smaller companies , including companies that may not have access to notified bodies within 
their country of domicile, or those not otherwise having existing long -standing 
relationships with notified bodies,  appear disproportiona tely affected by the insufficient 
number of designated notified bodies.  
• The recently passed corrigendum to the MDR, which extends the window for certain  Class 1 
devices to become certified,  is a positive step . However,  this does not sufficiently address 
capacity issues  for certification activities . Class 2 and Class 3 products remain  the most 
difficult and time -consuming products to assess  and we remain concerned that the 
insufficient number of Notified Bodies will prev ent the timely assessment of such products.   
4.  Second , the EU has drafted an insufficient number of the implementing acts needed to provide 
detail ed guidance  about how industry can ensure their products comply with the new product 
standards.  
• As of 20 Decembe r 2019 , it appears from the EU's website that  only three  of the 
12 implementing regulations have been issued , although several others appear to be 
under development.  As a result, EU standardizing bodies are still challenged to  begin work 
on developing the standards that industry may use to comply with the MDR/IVDR.  G/TBT/W/734  
 
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  • The existing MDR and IVDR  provisions for warehousing are insufficient to provide relief 
during the transition. Buyers and producers cannot predict demand, making it difficult to 
warehouse the right amount of product to meet that demand through the implementation 
delays. Moreover, warehousing is expensive, degradation is common with medical 
technology, and the technology itself can quickly become obsolete.  
• Further, the MDR and IVDR provisions for grace periods to provide relief during transition 
are also insufficient because CE mark  product registrations compliant with the old 
directives  may expire before the end of the grace period in 2024. Additionally, we have 
heard from companies that notified bodies are currently not issuing certifications  under 
the old system, hindering their a bility to take advantage of the grace period.  
5.  Given these concerns, what additional steps does the EU foresee taking to ensure there is not a 
market shortage  of medical devices starting in May 2020 ? We applaud the issuance of the first 
corrigendum  and believe it is a step in the right direction . As May 2020 approaches , will the EU 
consider other s imilar  measure s to help address continued implementation issues ?  
 
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