Read the full pillar: EU AI Act Article 9 explainer →
What the regulation requires
1. A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems. 2. The risk management system shall be understood as a continuous iterative process planned and run throughout the entire lifecycle of a high-risk AI system, requiring regular systematic review and updating. It shall comprise the following steps: (a) the identification and analysis of the known and the reasonably foreseeable risks that the high-risk AI system can pose to health, safety or fundamental rights when the high-risk AI system is used in accordance with its intended purpose; (b) the estimation and evaluation of the risks that may emerge when the high-risk AI system is used in accordance with its intended purpose, and under conditions of reasonably foreseeable misuse; (d) the adoption of appropriate and targeted risk management measures designed to address the risks identified pursuant to point (a). 6. High-risk AI systems shall be tested for the purpose of identifying the most appropriate and targeted risk management measures. Testing shall ensure that high-risk AI systems perform consistently for their intended purpose and that they are in compliance with the requirements set out in this Section.
What you face if you don't comply
Article 9 becomes enforceable on 2 August 2026 for high-risk AI systems and requires a documented, lifecycle-long risk management system — not a one-time assessment. Failure to maintain it routes through the Article 16 provider obligations and is sanctionable up to €15M or 3% of global annual turnover under Article 99(4). The operational consequence is that risk management must produce versioned, reviewable artefacts mapped to identified hazards, with testing evidence sufficient to defend the residual-risk judgement.
How RiskForge addresses this
- ¶ 9(1)Generates a versioned risk-management-system file: hazard register, risk owners, review cadence, change history
- ¶ 9(2)(a)Structured hazard identification across health, safety and fundamental-rights dimensions with intended-purpose framing
- ¶ 9(2)(b)Reasonably-foreseeable-misuse scenario library with likelihood × severity scoring and mitigation linkage
- ¶ 9(2)(d)Maps each identified risk to a targeted mitigation control and tracks residual-risk acceptance with sign-off trail
- ¶ 9(6)Test-plan generator tying each hazard to a measurable test, with prior-defined metrics and probabilistic thresholds (Art. 9(8))
Source: eur-lex.europa.eu/…/CELEX:32024R1689 · Retrieved