G/TBT/W/702  
 
29 November 2019  
(19-8217) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
EUROPEAN UNION - REGULATION OF THE EU ROPEAN PARLIAMENT AN D OF THE 
COUNCIL ON MEDICAL D EVICES, AND AMENDING  DIRECTIVE 2001/83/E C, REGULATION 
(EC) NO 178/2002 AND  REGULATION  (EC) NO 1223/2009  
REGULATION OF THE EU ROPEAN PARLIAMENT AN D OF THE COUNCIL ON IN VITRO 
DIAGNOSTIC ME DICAL DEVICES  
STATEMENT BY THE UNITED STATES 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 United States. 
 
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The United States supports the development and enforcement of a well -defined medical device 
regulatory system that 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 its continued access to the EU 's $125 billion medical device market, $20 billion of 
which is supplied by U.S. products.  
MDR/IVDR 's implementation is behind schedule. Our industry has two  main concerns. First, there 
is an insufficient number of Notified Bodies (NBs) designated to perform certification activities under 
the MDR/IVDR.  
With only five Notified Bodies currently designated, including one based in the UK, can the EU 
provide an est imate as to when all 58 will be operational? It is our understanding that DG GROW 
expects no more than 20 Notified Bodies to be designated as operational by the end of 2019, which 
is insufficient to ensure continued regulatory approvals by May 2020 and May  2022. Smaller 
companies appear disproportionally affected by the insufficient number of designated Notified 
Bodies.  
Second, the EU has drafted an insufficient number of the implementing acts needed to provide 
details about how industry can ensure their pr oducts comply with the new product standards.  
As of September 16, 2019, only two of the 18 implementing regulations have been issued and a 
third has been drafted. As a result, EU standardizing bodies cannot begin work on developing the 
standards that indus try may use to comply with the MDR/IVMDR.  
The 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 rel ief during transition are 
also insufficient. 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. Additionally, we have 
heard from companies that Notified Bodies are not issuing CE marks currently under the old system, 
hindering their ability to take advantage of the grace period.  G/TBT/W/702  
 
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Given these concerns, we urge the EU to allow legacy products that are currently deemed safe 
to be sold on the market un til 2024 and to ask Notified Bodies to grant new products, which require 
testing for the first time, priority access to Notified Body testing. We are open to other flexibilities 
that would provide relief to companies looking to access the market.  
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