How the EU AI Act reshapes regulation of medical software and devices

This cluster focuses on how AI-based medical software (SaMD) in Europe must now navigate overlapping requirements from the EU Medical Device Regulation (MDR/IVDR) and the new EU AI Act. The posts highlight that many clinical AI tools will be classified as high-risk, triggering strict conformity assessments, data governance, and monitoring obligations by 2026. They also stress the need for dual regulatory strategies for MedTech and hospital vendors, and place EU changes in the wider global context alongside FDA, TGA, PMDA, and NMPA frameworks. Together, the content serves as a practical guide for aligning AI product development, compliance, and commercialization in the EU healthcare market.