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AI in medical devices is high-risk through product law; other health uses may be too.

1 min read·Updated 8 November 2026HealthcareMedtech

Medical devices

AI that is, or is part of, a medical device under the MDR or IVDR, and that needs a notified body assessment, is high-risk under Annex I. Most diagnostic and clinical-decision software falls here. These obligations apply from 2 August 2028, and are assessed together with your existing MDR or IVDR conformity assessment.

Watch out

If V77 Trust shows "AI in healthcare is usually high-risk" on a system classified as minimal risk, re-check it. Diagnostic tools are almost never minimal risk.

Other health uses

  • Emergency triage and dispatch prioritisation are high-risk under Annex III.
  • Life and health insurance pricing is high-risk.
  • Scheduling, coding and administrative assistants are usually minimal risk, unless they decide access to care.

What to do now

  1. 1
    Classify every clinical AI system and link it to its device technical file.
  2. 2
    Map AI Act requirements to your existing quality management system (ISO 13485) and risk management (ISO 14971) rather than starting again.
  3. 3
    Make sure clinicians can understand and override outputs, and that this is trained and recorded.
  4. 4
    Use the incident register: serious incidents may need reporting under both device vigilance rules and the AI Act.

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