Article 9
Risk management system
High riskApplicable from August 2, 2026
Applies to: Provider
Providers of high-risk AI systems must establish, implement, document, and maintain a risk management system that runs continuously across the whole lifecycle of the system.
Key points
- Identify and analyse known and foreseeable risks to health, safety, and fundamental rights
- Estimate risks under intended use and reasonably foreseeable misuse
- Adopt targeted mitigation measures and residual-risk judgements
- Test the system against defined metrics before market placement
- Review and update on the basis of post-market monitoring data
Related terms
This page is a plain-language summary for orientation only. It is not legal advice — the binding text is Regulation (EU) 2024/1689.