What is High-risk AI system?
Under the EU AI Act, a high-risk AI system is one that is either a safety component of a product covered by listed EU product legislation, or falls within a use case listed in Annex III, such as employment, education or essential services. It must meet strict requirements before and after market placement.
Article 6 sets the classification routes, with a narrow exception for Annex III systems that pose no significant risk of harm, though systems that profile people remain high-risk. Requirements include risk management (Article 9), technical documentation (Article 11), human oversight (Article 14) and a quality management system (Article 17). Classification is a judgement that should be recorded with its reasoning.
Source: Regulation (EU) 2024/1689 (the EU AI Act), EUR-Lex. Last reviewed . General information, not legal advice.