Find Resources To Designate IVDR Notified Bodies, Commission Tells Member States
There is growing impetus at the highest EU levels towards ensuring the IVD Regulation is implemented as quickly and effectively as possible. Discussions at the Council of the EU have now added to this drive.
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Two long-awaited European Commission proposals have been published which shed light on how EU reference laboratories will operate under the IVD Regulation and likely timelines.
The European Commission has updated its figures on the status of readiness of notified bodies under the Medical Device and IVD Regulations. Three more designations are imminent, but just one under the IVDR.
The pressing circumstances created by the ongoing COVID-19 pandemic has resulted in the commission not only accepting compliance delays for some IVDs, but also longer transitional provisions than expected.