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AI Act: high-risk rules for AI in regulated products (Annex I)

European CommissionLegislation milestone High impact in 627 days
Date
Wed 02 Aug 2028
Body
European Commission
Scope
EU
Subject
Data & AI
Official source
ai-act-service-desk.ec.europa.eu

High-risk AI obligations apply to AI embedded in products under Annex I EU harmonisation legislation (which includes medical devices and IVDs). AI-enabled device makers need AI Act conformity on top of MDR/IVDR.

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Dates are taken from the official source above. Agencies occasionally reschedule; confirm on the source before acting.