High-risk AI systems in Annex I products apply

About this milestone

Article 113 sets 2 August 2028 as the application date for high-risk rules on AI systems that are safety components of, or themselves are, products covered by Union harmonisation legislation listed in Annex I. That list includes medical devices and in vitro diagnostics product rules. AI embedded in regulated medical products therefore faces the AI Act high-risk framework alongside MDR/IVDR from this date.