When classified as a medical device or in vitro diagnostic device under the MDR or IVDR (Annex I). AI for clinical decision support, diagnosis, treatment planning, and patient monitoring is typically high-risk.
5 questions answered with specific EU AI Act article references. 98 days until the August 2, 2026 enforcement deadline.
Not sure if your AI system is affected? Take the 5-minute diagnostic.When classified as a medical device or in vitro diagnostic device under the MDR or IVDR (Annex I). AI for clinical decision support, diagnosis, treatment planning, and patient monitoring is typically high-risk.
AI for scheduling, billing, or general patient communication is typically not high-risk. AI for triage, resource allocation affecting patient care, or insurance claims processing may be high-risk.
Yes. AI medical devices must comply with both the Medical Devices Regulation (MDR) and the AI Act. Conformity assessment under MDR may partially satisfy AI Act requirements.
If the AI provides recommendations that could directly influence diagnosis or treatment, it's likely a medical device and high-risk under both MDR and AI Act.
Only with human oversight. The AI Act requires human oversight (Article 14) and the ability for clinicians to override AI recommendations. Fully automated treatment decisions are not permitted for high-risk systems.
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