U.S. Urges EU to Delay Implementing EU MDR/IVDR by Three Years
With only nine months to go before the EU’s Medical Device Regulation hits its May 26 application date, the U.S. is pressing the EU to delay implementation for another three years.
In a letter to the World Trade Organization Committee on Technical barriers to Trade, the U.S. delegation said it had serious concerns about the implementation of the new regulations. It said that the industry is “worried about their continued access to the EU's $125 billion medical device market, $20 billion of which is supplied by U.S. products.”
The letter points to the ongoing lack of notified bodies in the EU to perform certification activities under the MDR/IVDR and the delay in drafting needed implementing acts.