All high-risk AI systems that are medical devices must comply with AI Act requirements including risk management, data governance, technical documentation, logging, transparency, human oversight, and cybersecurity standards. Penalties up to €15M or 3% of global turnover.
EC AI Act & Regulation · July 12, 2024
AI Act for Medical Devices
High-risk AI systems in medical devices must meet AI Act requirements on risk management, data governance, documentation, logging, transparency and oversight, with penalties up to €15M or 3% of global turnover.
Enters Force
August 02, 2027
Published by EC AI Act & Regulation. HealthSignal links to the original document; the summary above is extracted from the source text.