The EU AI Act (Regulation (EU) 2024/1689) marks a significant step in regulating Artificial Intelligence (AI) across the European Union. It aims to govern the placement on the market and use of AI systems, particularly those posing high risks to individuals.
Navigating the EU AI Act: A Guide for Medical Device Manufacturers Lire la suite »
CE News
The European Commission has confirmed that four components of the European Database on Medical Devices (EUDAMED) are now fully operational and
EUDAMED: Reaches a Major Milestone with 4 Modules now fully Deployed Lire la suite »
CE News
UE NEWS Simon Medtech Solutions New EU Harmonized Standards Enter Into Force for Medical Masks, Gowns, and Sterilizers On 17 October 2025, the European Commission issued Implementing Decision (EU) 2025/2078, updating the list of harmonized standards applicable to several categories of medical devices. The revision covers: Surgical gowns and drapes Medical face masks Steam
