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Medical AI sits at the intersection of MDR 2017/745 (medical devices) or IVDR 2017/746 (diagnostics) AND the EU AI Act. Annex I embedded high-risk requires dual conformity assessment with the notified body integrating both regimes.
Healthcare AI is the cleanest example of multi-regime stacking under EU product law. AI that qualifies as a medical device under MDR or IVDR is Annex I embedded high-risk under the AI Act, both regimes apply. The dual-conformity route lets the notified body integrate the AI Act conformity assessment with the existing MDR/IVDR work, avoiding duplication. Article 73 incident reporting runs in parallel with MDR vigilance reporting on coordinated submission. Article 14 human oversight requirements layer onto existing clinical-validation standards. The 2 August 2028 deadline for Annex I embedded high-risk (post-Omnibus) lands within the typical MDR re-certification cycle.
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.
Read articleA practical guide to AI incident response under the EU AI Act. 6-step response plan, Article 26(5) reporting obligations, whistleblower protections, and real incident examples.
Read articleOn 7 May 2026 the EU Council and Parliament reached a provisional agreement to delay the high-risk AI deadlines. Annex III standalone systems now apply from 2 December 2027, Annex I embedded systems from 2 August 2028. Article 4 literacy and Article 5 prohibited practices are unchanged and still live.
Read articleFind out if your AI tools are high-risk under the EU AI Act. Annex III categories explained with real examples: ChatGPT, Copilot, Salesforce, and more.
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5-minute scored assessment across People, Tools, Compliance, and Infrastructure. See where you sit on this topic in operational terms.
