What EU AI Act - Risk Management System for High-Risk AI Systems (Article 9) requires
EU AI Act (Regulation 2024/1689) Article 9 requires providers of high-risk AI systems to establish, implement, document, and maintain a risk management system throughout the entire lifecycle of the high-risk AI system; the Article 9 risk management system must be a continuous iterative process running throughout the AI system's lifecycle - from design through development, testing, deployment, and post-market operation; Article 9(2) - the risk management system must cover: (a) identification and analysis of the known and reasonably foreseeable risks associated with the high-risk AI system; (b) estimation and evaluation of risks that may emerge when the AI system is used in accordance with its intended purpose and under conditions of reasonably foreseeable misuse; (c) evaluation of other possibly arising risks based on analysis of post-market monitoring data; (d) adoption of appropriate and targeted risk management measures; Article 9(3) - risk management measures must give due consideration to the effects and possible interaction of the measures implemented to minimise cumulative side effects; Article 9(4) - providers must implement testing to identify the most appropriate risk management measures; testing must be performed against predefined metrics and probabilistic thresholds appropriate to the intended purpose; Article 9(5) - the risk management system must specifically consider the risks to health, safety, and fundamental rights of persons who may be particularly vulnerable due to age, disability, or social/economic situation; Article 9(6) - providers must adopt measures to ensure adequate levels of accuracy, robustness, and cybersecurity and minimise risks arising from inaccuracies; the Article 9 risk management system documentation feeds directly into the technical documentation under Article 11 and Annex IV and is reviewed as part of conformity assessment under Article 43.
Pillar: AI Governance & Law · Authority: European Parliament and Council of the EU · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1689
SHA-256 integrity: 7bc74bae88c7b111e9ac9907ec72643b86eeb2155539826507cd2c01bacb9bec
Primary Citations — 5 traced to source
- {"title":"Regulation (EU) 2024/1689 - EU AI Act: Article 9 - Risk Management System","url":"https://eur-lex.europa.eu","relevance":"Primary EU AI Act provision establishing the mandatory risk management system for high-risk AI system providers - Article 9 specifies the continuous iterative lifecycle requirement, risk identification scope (intended use, misuse, vulnerable populations), testing requirements (Article 9(4)), risk management measure hierarchy, and post-market monitoring integration obligations"}
- {"title":"Regulation (EU) 2024/1689 - EU AI Act: Article 11 and Annex IV - Technical Documentation","url":"https://eur-lex.europa.eu","relevance":"EU AI Act provision linking the Article 9 risk management system to the technical documentation - Annex IV requires risk management documentation including identified risks, risk management measures, and residual risks as mandatory elements of the technical documentation prepared for conformity assessment"}
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