European Commission Accelerates Eudamed Registration Ahead Of Planned Timetable
Registration in the European medical device database, Eudamed, is a cornerstone of the full functionality of the Medical Device and IVD Regulations. After fitful progress with Eudamed development, advances are now being announced.
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A formal notice ends the debate over the legality of making modules of the new Eudamed 3 medical device database available as soon as they are ready.
The hope is now that a new EU document will be issued to address head on the scale of bottlenecks at notified bodies and of products needing to be removed from the market.
With a sense of desperation building among stakeholders over the challenges in ensuring all products are compliant with the Medical Device Regulation in time, high-level solutions are being considered. But a further MDR delay is not an option.