European Commission Gives In On IVDR Delays: Proposal For New Transition Periods
Some Products To Get Until 2025-2027 For Compliance
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.
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Might the EU decide to go the way of the IVD Regulation with the Medical Device Regulation and allow devices certified under the former regime to remain on the market into the mid 2020s and beyond?
With the European Parliament, Council of the EU and European Commission aligned over the urgent need for some staggering of deadlines for products under the forthcoming IVD Regulation, adoption of the amending regulation is expected on 21 December.
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.