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.

The European Parliament has voted in favor of the European Commission’s proposal to amend the IVD Regulation by introducing transition provisions for certain IVDs. There were 697 votes in favor, six against and four abstentions.The Council of the EU is now due to take a final vote on 21 December.

The process was conducted during a European Parliament plenary session as an urgent procedure in response to a commission...