§ AI Act · Article 9
Risk Management System for High-Risk AI Systems
Regulation (EU) 2024/1689
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Article 9
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Source
Plain-language summary
Providers of high-risk AI systems must establish, implement, document, and maintain a continuous risk management system throughout the AI system's lifecycle. This system requires regular reviews and updates to identify, analyze, and evaluate risks to health, safety, or fundamental rights, including those affecting vulnerable groups. Providers must estimate and assess these risks, implement measures to mitigate them, and ensure remaining risks are acceptable. The system must also include testing to validate risk management measures and confirm the AI system operates as intended.
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AI Act Annex III high-risk
400 days
until 2027-12-02, when Annex III high-risk obligations apply under the Digital Omnibus on AI (Regulation (EU) 2026/1744, in force since 27 July 2026). Article 50 transparency obligations have applied since 2 August 2026.