• 2026-06-26 05:27:53

Commission Implementing Regulation (EU) 2026/977 establishes uniform quality management and procedural requirements for notified bodies designated under MDR (EU) 2017/745 and IVDR (EU) 2017/746. The Regulation aims to harmonize conformity assessment practices, improve transparency and predictability, and ensure consistent treatment of manufacturers across the European Union.

• 2023-09-27 07:30:22

A survey on certifications and applications of MDR-IVDR was conducted in April 2023. The result of the survey is published.

• 2023-02-23 01:59:23

The statistics as of January 2023 regarding the coverage of designation codes by MDR/IVDR notified bodies has been published in the attachment.

• 2022-08-31 05:37:18

MDCG 2022-12 provides guidance to Member States and other relevant parties on the application of certain IVDR provisions during the absence of Eudamed. This guidance intends to describe harmonized administrative practices and alternative technical solutions for the exchange of information until Eudamed becomes fully functional.

• 2022-07-26 11:06:32

MDCG 2022-8 provides guidance regarding the applicability of IVDR requirements to "legacy devices" and "old" devices. The annex contains a non-exhaustive table illustrating IVDR requirements applicable or not applicable to “legacy devices”.

• 2020-09-15 06:35:40

MDCG has published a guidance for notified bodies on the use of MDASP audit reports in surveillance audit carried out under MDR/IVDR. For those with similar or equivalent requirements, positive QMS conformity result might lead to a reduction of the focus on covered aspect.