European Commission Formally Pledges Eudamed Modules On Rolling Basis
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.
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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.
Latest information from the European Commission suggest that future notified bodies designated under the MDR, and even the IVDR, may not be in a position to issue certificates until March 2023.
The highest risk IVDs are due to receive an extra layer of regulatory scrutiny in the EU. But it is taking a long time to set up the structures needed.