European Commission Gives In On IVDR Delays: Proposal For New Transition Periods
Some Products To Get Until 2025-2027 For Compliance
Executive Summary
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.
You may also be interested in...
Call For Risk-Based Extension For Legacy Products And No Sell-Off Deadline Under EU MDR
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?
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.
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.