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:
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)