MDR/IVDR: Commission updates on implementation, notified body designation

Regulatory NewsRegulatory News | 12 April 2021 |  By 

The European Commission last week updated its rolling plan detailing the actions and initiatives necessary to ensure the smooth rollout of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
With MDR’s date of application just weeks away, Finland’s Eurofins Expert Services Oy on Wednesday became the 20th notified body designated under the regulation. Just four notified bodies have been designated under IVDR.
Based on the pipeline of notified bodies undergoing assessment, there are eight more notified bodies for devices and one on the IVD side that that have reached the final stages of the designation process. Even more are in the middle stages of review, though it could take upward of a year for the notified bodies in those stages to receive designations.
Much of the Commission’s remaining to-do list for MDR and IVDR relate to the establishment of common specifications for devices and high-risk IVDs, Eudamed and EU reference laboratories (EURLs) for IVDs.
Accord to the rolling plan, common specifications for devices without a medical purpose listed in MDR Annex XVI are expected in Q3 2021 and common specifications for class D IVDs are expected in Q2 or Q3 of this year.
With Eudamed’s date of application now pushed back to May 2022, the Commission now expects to issue an implementing act defining the arrangements necessary for the database’s maintenance and support in Q2 2021.
Three actions related to EURLs have been pushed back, with an implementing act on the designation of such laboratories now expected some time between Q3 2021 and Q1 2022. The establishment of rules to facilitate the fulfillment of tasks by EURLs and establishing the fees they may charge for services are now expected in Q2 2021.
The Commission gave an update on its MDR/IVDR standardization request after the EU standardization organizations CEN and Cenelec rejected its previous request last year. The Commission says its new draft implementing decision was approved by the Committee on Standards last month and that it will adopt the implementing decision and send it to CEN and Cenelec within the next month. If the request is accepted, the Commission says that implementing decisions with the lists of references of harmonized standards will be published periodically throughout the remainder of 2021.
European Commission


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