AI as Medical Device - Interaction between the AI Act and the Medical Device Regulation
summary
Explains that software is a medical device only when tied to a specific disease and patient use, and that an AI using learning techniques is high-risk AI automatically if it falls under the Medical Device Regulation list; conformity assessment is unified so one notified body checks both MDR and AI Act requirements; the AI Act explicitly allows continuous learning models to change post‑market without repeated re-certification provided changes stay within the pre‑defined scope, solving the current “locked AI” limitation.
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chapters (7)
- 0:00Introduction
- 1:06AI regulation challenges
- 3:37AI Act and MDR interaction
- 5:24Key definitions
- 8:13High-risk AI systems
- 10:44Conformity assessment
- 15:38Continuous learning AI
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