Summary
Horizontal EU law establishing risk-based obligations, bans for certain practices, requirements for high‑risk AI (e.g., quality management, data governance, human oversight), transparency duties for specific systems, and market surveillance/enforcement mechanisms.
Healthcare Implications
Many clinical AI products will fall under existing Medical Device Recognition/In Vitro Diagnostic Regulation as medical devices and also under the AI Act as high‑risk AI (Annex II/III cross‑references), driving additional documentation, post‑market monitoring, and transparency. Hospitals and vendors should align conformity assessment, data governance, and human‑oversight controls across MDR/IVDR and the AI Act.