The Council of the EU has voted to adopt the amending regulation to the Medical Device and IVD Regulations which enables a gradual rollout of the Eudamed medical device database, further extends the deadline for transitioning to the IVDR for certain IVDs and requires companies to forewarn about potential device supply interruptions.
MDR/IVDR Amending Document Finally Adopted
Prior notice about device supply interruption is to become mandatory
In this amendment to both the Medical Device and IVD Regulations, the IVD Regulation timelines will be eased and Eudamed will be rolled out before the entire database is ready.
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