Classification Rules for High-Risk AI Systems

This article establishes the criteria for classifying AI systems as high-risk. An AI system is considered high-risk if it functions as a safety component of a product or is itself a product covered by EU harmonisation legislation listed in Annex I. Systems listed in Annex III are automatically high-risk unless they do not pose significant risks to health, safety, or fundamental rights. Providers must document their assessment if they claim their AI system is not high-risk before market placement or use. The European Commission may issue guidelines and adjust classification conditions, ensuring any changes do not reduce protection levels.