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.