How Notified Bodies Must Conduct Surveillance On Legacy IVDs
Certain CE-marked IVDs may remain on the market for up to three years after the IVD Directive expired. New guidance shows how notified bodies must keep working with manufacturers to ensure their safety.
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With news that new version of the European Commission’s Eudamed medical devices database is not going to be fully ready until the second quarter of 2024 two years after the full application of the IVDR on 26 May new EU guidance has been published to help IVD manufacturers understand in detail what they should do in the meantime.
New designations of notified bodies under the Medical Device Regulation continue to trickle through slowly. The latest brings the EU’s total to 33, still way short of the previous 80 or so under the Medical Devices Directive.
Changes have occurred in the management focus within the European Commission’s directorate responsible for medtech but not within the devices leadership; familiar faces remain.