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
May 73 min read
EC Guidance: Transition from Clinical Trials Directive to the Clinical Trials Regulation
The European Commission (EC) has long recognized the importance of streamlining and harmonizing the regulation of clinical trials across...
Sharan Murugan
Jul 24, 20232 min read
EC MDCG: Med Dev Guidance on Significant Changes regarding the Transitional Provision MDR
The European Commission’s Medical Device Coordination Group (MDCG) released updated guidance "Guidance on significant changes regarding...
Sharan Murugan
May 13, 20231 min read