Glossary · Regulation
High-risk AI system
High-risk AI system (EU AI Act)
A high-risk AI system is the EU AI Act category for AI that can seriously affect health, safety or fundamental rights, including AI that is a safety component of a regulated product such as a medical device.
Before reaching the market it needs risk management, quality training data, logging, documentation, human oversight and robustness, which for medical AI is assessed alongside the MDR or IVDR.
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Definitions written by Anpheros from the official sources linked on each page. General information about standards and regulation, not legal or medical advice. All terms →