EU AI Act compliance for healthcare AI

AI that is a medical device, or a safety component of one, is high-risk under the EU AI Act and must be reconciled with the Medical Device Regulation. Documentation and conformity assessment are central.

Why it is in scope

AI embedded in regulated medical products (Annex I) is high-risk; the Digital Omnibus reschedules these embedded-product obligations to 2 August 2028 (provisional, pending formal adoption).

Key obligations

• Risk management aligned with MDR and Article 9
• Data governance and clinical data quality (Article 10)
• Annex IV technical documentation (Article 11)
• Accuracy, robustness, and post-market monitoring (Articles 15, 72)
• Conformity assessment, often via a notified body (Article 43)