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Eudamed: Industry Warned That Additional National Actor Registration Requirements Possible While Database Is Voluntary

 
• By Amanda Maxwell

As manufacturers and other economic operators gets to grips with voluntary registration in the Eudamed database, they need to be prepared for additional registration at national level too.

European flags (Markus Pfaff/Shutterstock.com)

The first module of the EU medical device database, Eudamed, is now live. But because actor registration is voluntary until 26 May 2022, when the entire database needs to be ready and fully apply, individual member states are within their rights to demand actor registration on a national basis under the Medical Device Regulation (MDR).

In other words, while the UK is establishing its own medical device rules, including its own actor registration requirements,...

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