On 5 May 2026, Commission Implementing Regulation (EU) 2026/977 of 4 May 2026 laying down certain uniform quality management and procedural requirements for the conformity assessment activities carried out by a notified body designated under Regulations (EU) 2017/745 and (EU) 2017/746 has been published in the Official Journal of the European Union. It amends Annex VII to the MDR/IVDR and introduces maximum timelines for conformity assessment activities of medical devices conducted by notified bodies subject to clock-stop procedures.

AESGP welcomes the adoption of Commission Implementing Regulation and believes that its measures will contribute to improved predictability and efficiency in relation to the quality management and processes in the context of conformity assessment activities.