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MDR/IVDR Amending Document Finally Adopted

Prior notice about device supply interruption is to become mandatory

 
• By Amanda Maxwell

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.

Healios will announce further strategy on acquired assets from Athersys once its policy is finalized, the firm says.
• Source: Shutterstock

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.

This means that the text accepted by the European Parliament in April has now passed the final hurdle and will be published in the Official Journal of the EU and...

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