A definitive regulatory analysis detailing the classification, conformity assessment, and clinical evaluation of autonomous medical software in Europe.
Under Rule 11 of the European Medical Device Regulation (EU MDR), software intended to provide information used to take decisions with diagnosis or therapeutic purposes is classified as Class IIa, IIb, or III depending on the potential severity of patient outcome. Autonomous agents guiding critical therapy default to the highest risk tiers.
How medical device manufacturers must simultaneously satisfy the medical safety requirements of EU MDR Annex I and the high-risk AI system mandates of the EU AI Act (including risk management, transparency, human oversight, and cybersecurity).
Methodologies for demonstrating clinical safety and performance: compiling prospective multi-center clinical investigation data, evaluating algorithmic bias across diverse patient demographics, and preparing Notified Body technical documentation.