Press Releases

AdvaMed Commends Passage of EU MDR Changes to Ensure Continued Access to Lifesaving Treatments for European Patients

WASHINGTON – Today, the European Union Council approved legislative changes to the Medical Device Regulation (EU MDR), finalizing a 3-4 ½ year extension on implementation of the new rules for certifying medical devices. The extension, which AdvaMed advocated for alongside its partner Medtech Europe, ensures continued access to life-saving medical technology and innovation and research and development in the EU market.

“Today’s vote by the EU Council gives the U.S. medtech industry the opportunity to continue saving and improving the lives of patients in Europe. The EU is one of the world’s preeminent markets for quality patient care, R&D, and access, serving millions of patients annually, so it’s critical that MDR implementation is done correctly,” said Scott Whitaker, AdvaMed President and CEO. “Together with Medtech Europe, we’re working to fully address several remaining issues, including a clearer process for submitting applications to notified bodies, as well as greater clarity on how certificate extensions can be demonstrated. We are also working to address practical implementation issues, such as access to ‘orphan’ and niche devices in the EU market. This is a strong step forward for patients worldwide, and AdvaMed will continue to champion a robust EU regulatory scheme that fosters innovation and patient access to treatment in a timely and predictable manner.” 

The legislative amendments to EU MDR will: