Search
European Commission: Introduces New Rules for Notified Bodies Under MDR and IVDR
The European Union has taken another major step toward strengthening the efficiency, predictability, and consistency of medical device and in vitro diagnostic (IVD) certification processes. On 4 May 2026, the European Commission adopted Commission Implementing Regulation (EU) 2026/977, which was subsequently published in the Official Journal of the European Union on 5 May 2026. The regulation establishes uniform quality management and procedural requirements for conformity as
Sharan Murugan
20 hours ago3 min read