G/TBT/W/679  
 
24 July 2019  
(19-4907) 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 UNITED STATES TO THE COMMITTEE ON TECHNICAL BARRIERS T O TRADE  
20 AND 21 JUNE 2019  
The following communication, dated 23 July 2019, 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 whi ch assures the safety and performance of medical devices.  However, the 
United States has serious concerns regarding the implementation of the MDR and IVDR, and our 
industry is worried about their 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 is behind schedule. Our industry has two particular concerns about 
this.  
i. One, there is an insufficient number of Notified Bodies (NBs) to perform certification 
activi ties under the MDR/IVDR.   
ii. And, two, the EU has drafted an insufficient number of the implementing acts needed 
to provide details about how industry can ensure that their products comply with the 
new product standards.   
3.  Can the EU provide an update on how m any of the 58 NBs accredited to test and certify products 
under old directives are currently designated as operational under the new MDR and IVDR, and how 
many the EU expects to be designated as operational by the end of 2019?  Our understanding is that 
DG GROW expects no more than 12 NBs to be designated as operational by the end of 2019. 
12 NBs are not enough to provide sufficient capacity to ensure continued regulatory approvals by 
May 2020 and May 2022.  
4.  Only two of the eighteen implementing regulations have been issued, and as a result, 
EU standardizing bodies cannot begin work on developing the standards industry may use to comply 
with the MDR/IVMDR. Given, this backlog industry maintains that the product standards necessary 
for compliance with the MDR cannot be completed before the deadline.   
5.  The MDR and IVDR provisions for warehousing and a grace period, which are intended to provide 
transitional relief, are insufficient. The warehousing provision is insufficient because buyers and 
producers cannot pre dict 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. The grace periods are insufficient because CE mark product registrations compliant with 
the old directives may expire before the end of the grace period, in 2024.   
6.  Given these concerns, we urge the EU to delay implementation by three years to al low for U.S. 
exporters to adapt to the new requirements.  G/TBT/W/679  
 
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  7.  If that is not possible, we urge the EU to allow for legacy products that are currently deemed 
safe to be sold on the market until 2024 and to ask Notified Bodies to provide new products, which 
require testing for the first time, with priority access to testing and CE marking certification over 
products being re -certified to the new requirements.  
 
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