How Does The Eudamed Module On Notified Bodies And Certificates Work?
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.
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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.
The latest version of the Eudamed medical device database has been upgraded and kickstarts the sharing around the EU of more key regulatory information.
Unique Device Identification (UDI) is key to better transparency and traceability in the EU. But this UDI is new to EU medtech manufacturers and complex. The commission has published some helpful pointers.