EU deal keeps AI medical devices under AI Act high-risk rules, delayed to 2028

In the Digital Omnibus on AI, Parliament and Council rejected the Commission's December 2025 proposal, made in its MDR/IVDR simplification package, to move medical devices and IVDs to Annex I Section B, which would largely have exempted them from AI Act high-risk duties. Instead, AI-enabled devices stay covered in parallel with the MDR/IVDR, with obligations for product-embedded high-risk AI pushed from August 2027 to 2 August 2028, and the Commission can limit overlap through implementing acts. The deal was formally adopted as Regulation (EU) 2026/1744 in July 2026.