EU AI Act for Healthcare: Why AI in Diagnostics, Triage, and Clinical Decision Support Lands in the High-Risk Category
Healthcare AI sits in the high-risk category by two paths. Annex III lists AI used in employment and essential services. The Medical Device Regulation pulls in any AI that meets the definition of a medical device, including most diagnostic and triage tools. The combination means most clinical AI deployments owe both the EU AI Act high-risk obligations and the MDR conformity assessment. The August 2, 2026 deadline applies, and the record-keeping infrastructure most hospitals run today fails the Article 12 test.
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