Implementing Regulation (EU) 2026/977 – uniform requirements for conformity assessment and notified bodies (Annex VII)
On 5 May 2026, the Official Journal of the EU released Commission Implementing Regulation (EU) 2026/977. This Regulation lays down uniform quality management and procedural requirements for the conformity assessment activities carried out by a notified body under the EU Medical Devices Regulations (MDR and IVDR). The new rules aim at addressing diverged practices among notified bodies across the EU, increasing transparency on quotations and timelines, and streamlining recertifications.
Read the news published by DG Health and Food Safety on 5 May 2026.
OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (26 mai 2026). Implementing Regulation (EU) 2026/977 – uniform requirements for conformity assessment and notified bodies (Annex VII). ELSIBI. Consulté le 7 octobre 2026 à l’adresse https://doi.org/10.58079/169tr
