Regulation · November 2026
AI Act and medical devices: what to plan for
AI built into a medical device generally falls under high-risk systems. Here are the three workstreams to start now.
Frameworks add up, they do not replace each other
The EU AI Act applies on top of the MDR and IVDR. A diagnostic or decision-support software therefore combines the medical device conformity assessment with the requirements specific to high-risk AI systems.
Three workstreams to start
- Risk management and data quality: document training datasets, their biases and representativeness.
- Technical documentation and traceability: event logs, model versions, design decisions.
- Human oversight: define who checks, when, and how the clinician can override a recommendation.
Our view
The most efficient path is to build these requirements into the existing quality system (ISO 13485, IEC 62304) rather than create a parallel one. The application timeline is phased and should be checked case by case depending on the product.
General information, not legal advice.