The European Commission expands the list of Class IIb implantable devices exempt from individual technical documentation assessment under MDR Article 52(4).

Swissmedic releases GPMV-Spital, a new framework for materiovigilance in hospitals. Understand the impact on medical device manufacturers and post-market surveillance.

Team-NB releases a position paper defining how manufacturers can transfer notified body surveillance for legacy devices under MDR Article 120, including key requirements, timelines, and responsibilities.

Swissmedic updates guidance on systems and procedure packs. Key obligations, CH-REP requirements, and impact for medical device manufacturers.

MDCG 2025-8 Rev.1 provides guidance on Master UDI-DI implementation for spectacle frames, lenses, and reading spectacles under EU MDR. Learn key requirements, timelines, and assignment rules.

Discover the latest European Commission update on ERNs and what their expansion means for medical device manufacturers in rare disease areas.

Swissmedic has published version 1.2 of its guidance on the Medical Device Publication Service, clarifying how Field Safety Corrective Actions and Field Safety Notices are published and accessed.

Discover how MDCG 2025-9 opens a new regulatory pathway for breakthrough medical devices and IVDs under MDR and IVDR. Learn what manufacturers need to know to benefit from early designation, lifecycle evidence flexibility, and post-market strategies.

There's a symbol update you can't ignore. With the release of Amendment 1 to ISO 15223-1, the European Authorized Representative symbol is changing from EC REP to EU REP.

Team-NB 's official position paper on the implementation of the AI Act offers key guidance for manufacturers of medical devices with artificial intelligence. The document analyzes the integration between the AI Regulation and the requirements already established by the MDR and IVDR, underlining the classification of devices with AI as high-risk systems.

The European Commission has released the updated list of National Contact Points for the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This essential resource supports compliance for manufacturers, distributors, and stakeholders in the medical device industry. The document includes key updates, such as revised details for Estonia's State Agency of Medicines. Stay informed about the MDR/IVDR landscape, ensure regulatory compliance, and access direct communication with EU competent authorities. Download the latest MDR and IVDR contact points document to stay ahead in the medical device and diagnostic regulation industry.