
EU AI Act for Healthcare AI: Medical Devices, Diagnostics, and Clinical Decision Support
Healthcare AI sits at the intersection of two regimes: the EU AI Act + sectoral product law (MDR / IVDR). This guide covers Annex I embedded high-risk classification, the dual conformity assessment route, Article 73 incident reporting on top of MDR vigilance, and the 2 August 2028 deadline post-Omnibus.










