Important development for the MDR and IVDR regulatory framework
The Commission Implementing Regulation (EU) 2026/977 of 4 May 2026 – on Annex VII – has been published in the Official Journal of the European Union
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 of the European Parliament and of the Council
The Regulation is available here