IVDR Amending Proposal And New Transition Provisions Due To Be Formally Adopted On 21 December
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.
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The Council of the EU has followed the European Parliament in rubberstamping the European Commission’s proposal for selected IVDR transition deadline extensions, as expected. Industry has expressed relief, but points to other outstanding IVDR issues that also need urgent EU attention.
The Council of the EU has paved the way for swift adoption of the proposal to amend the IVD Regulation, given the pressures the IVD sector is under. All eyes are now on the European Parliament.
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.