Latest European Commission Figures Suggest One More IVDR Notified Body In Pipeline And Then A Gap
Executive Summary
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.
You may also be interested in...
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.
European Commission Gives In On IVDR Delays: Proposal For New Transition Periods
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.
Go-Ahead For Appointment Of European Union Reference Labs For IVDs
EURLs have been a critical missing element of the IVDR for assessing the higher-risk class D IVDs. Two new implementing regulations, on fees and tasks, bring them closer to designation.