Healthcare AI faces some of the strictest requirements under the EU AI Act. Most medical AI systems are classified as high-risk under Annex III Category 5, with additional dual compliance obligations under the Medical Devices Regulation.
Healthcare is one of the most heavily regulated sectors under the EU AI Act. AI systems used in medical diagnostics, triage, treatment planning, and insurance underwriting are explicitly listed as high-risk in Annex III, Category 5 (access to essential private and public services). When these systems are also classified as medical devices, they face dual compliance requirements under both the AI Act and the Medical Devices Regulation (MDR 2017/745).
AI-assisted diagnosis, pathology analysis, and clinical decision support systems that influence medical decisions.
AI analysis of X-rays, MRIs, CT scans, and other medical images for detection and diagnosis.
AI systems that prioritize patients based on urgency, allocate resources, or route to specialists.
AI-driven drug candidate identification, molecular modeling, and clinical trial optimization.
AI systems used to assess risk, set premiums, or make coverage decisions for health insurance.
AI for scheduling, billing, documentation, and other non-clinical administrative tasks.
Most healthcare AI systems fall under Annex III, Category 5 (access to and enjoyment of essential private services and essential public services and benefits). AI systems that are also medical devices must comply with Annex I, Section A (harmonised legislation for regulated products). This dual classification means healthcare AI often faces the most rigorous compliance requirements of any sector.
Identify every AI system used in clinical decision-making, diagnostics, triage, and patient-facing interactions.
For AI systems classified as medical devices, map requirements across both the AI Act and MDR. Conformity assessment under one regulation may satisfy parts of the other.
Document clinical evidence, performance benchmarks, and safety testing specific to medical AI applications.
Define how clinicians oversee AI recommendations, including override procedures and escalation paths for edge cases.
Ensure all healthcare professionals using AI tools understand their capabilities, limitations, and the regulatory framework.
In-depth guide covering MDR dual compliance, Annex III Category 5, and healthcare-specific requirements.
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