AdvaMed, Department of Commerce Partner to Secure EU MDR Extension

WASHINGTON, D.C. – AdvaMed, the medtech association, working alongside the Department of Commerce’s International Trade Administration, advocated for and secured the recently implemented transition extensions for certifying medical devices in the European Union under the Medical Device Regulation (MDR). The effort ensures nearly $24 billion of U.S. medical technologies will remain available in the EU market.

Scott Whitaker, AdvaMed President and CEO said: “The European Union is one of the world’s top medtech markets, with millions of patients there relying on U.S. medical technology that has already met FDA’s rigorous standards. Working with the Department of Commerce, we represented the medtech industry to EU member states and shared our recommendations to improve MDR implementation. In addition to our work with Medtech Europe, we are proud of our close collaboration with the Biden administration to advocate on behalf of patients worldwide. There are still issues to address, and we look forward to working with the EU to ensure the system fosters innovation and improves patient access to medtech’s lifesaving technologies.”

In a statement, the Department of Commerce said: “The Department of Commerce’s International Trade Administration (ITA) is proud to have worked closely with the AdvaMed to advocate for the recently implemented transition extensions for certifying medical devices in the European Union under the new Medical Device Regulation… ITA appreciated AdvaMed’s proactive approach and strong partnership to successfully address this market access barrier, which required a team effort from many of our offices across the bureau and close coordination with our counterparts at AdvaMed.”

The legislative amendments to EU MDR will:   

• Extend the transition period to December 2027 for Class III and IIB implantables  
• Extend the transition period to December 2028 for Class IIB non-implantables, and Class IIA and Class I devices (requiring notified body assessment)  
• Abolish the warehouse provision for both MDR and In Vitro Diagnostic Regulations      
• Provide a new transition period for Class III custom-made implantables to May 2026 (assuming applications are submitted by May 2024)

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