Eudamed Temporarily Unavailable As ‘Major Upgrade’ Signals Two New Modules
Despite IT system enhancements tending to take longer than expected, the European Commission’s expansion of the Eudamed medical device database looks imminent and to arrive just about on time.
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The latest version of the Eudamed medical device database has been upgraded and kickstarts the sharing around the EU of more key regulatory information.
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.