How To Register Devices In Eudamed: The Process And The Pitfalls
It is still early days whenit comes to registering in the UDI/Devices module of the Eudamed database. The European Commission has now issued a guide to help users navigate the complex process. It is featured on a webpage dedicated to UDI/Devices registration.
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News relating to the implementation of the EU's Eudamed medical device database is coming thick and fast now. Plenty of material to help stakeholders prepare for the complex new provisions; this time the support is for notified bodies.
Updates and speculation surrounding the Eudamed medtech database has attracted significant attention in November. It was also an impactful month for IVDR news too, and for moves strengthening the medtech and pharma interface.
The European Commission has published an Implementing Regulation explaining some of the fundamental practices that need to be carried out by different actors from the beginning for Eudamed to operate successfully.