European UnionAI Act, Article 9 (risk management system)
Regulation (EU) 2024/1689, Article 9
Amended by Regulation (EU) 2026/1744, which moved its start date from to for a high-risk AI system classified under Article 6(2) and Annex III.
An AI risk obligations rule binding public and private bodies.
- How the hook was established
- express
- What makes it apply
- Market targeting, Place of effect
- Obligation class
- Governance
- Audit expectation
- continuous
- Who audits it
- Self
What it requires
- This duty takes effect on for a high-risk AI system classified under Article 6(2) and Annex III, and on for one classified under Article 6(1) and Annex I, other than a system related to a product covered by the Union harmonisation legislation listed in Section B of Annex I, to which, under Article 2(2), only Article 6(1), Article 60a and Articles 102 to 112 apply, and Articles 57, 58 and 59 apply only in so far as the requirements for high-risk AI systems under this Regulation have been integrated in that Union harmonisation legislation; a system already placed on the market or put into service before its date is reached only once its design changes significantly, or by if it is intended for use by public authorities.
- If you are the provider of a high-risk AI system, establish, implement, document, and maintain a risk management system for it, run as a continuous process across its whole lifecycle with regular review and updates.NIST AI RMFGOVERN 1.4
- Identify and analyze the known and reasonably foreseeable risks the system can pose to health, safety, or fundamental rights under its intended use, and estimate and evaluate risks that may emerge under intended use and reasonably foreseeable misuse.NIST AI RMFMAP 5.1
- Fold in other risks surfaced by your post-market monitoring data, and adopt targeted risk management measures for the risks you identified.NIST AI RMFMANAGE 1.3
- Bring residual risk, per hazard and overall, down to an acceptable level: eliminate or reduce risk through design and development where technically feasible, then mitigate or control what cannot be eliminated, then provide required information and, where appropriate, deployer training, taking the deployer's likely expertise and context of use into account.NIST AI RMFMANAGE 1.3
- Test the system to confirm your risk management measures work, that the system performs consistently for its intended purpose, and that it meets the Section 2 requirements; you may use real-world testing under Article 60 for this. Test throughout development and, in any event, before placing the system on the market or putting it into service, against metrics and probabilistic thresholds set in advance.NIST AI RMFMEASURE 2.3
- Consider whether the system is likely to adversely affect persons under 18 or other vulnerable groups, given its intended purpose, when implementing your risk management system.NIST AI RMFMAP 5.1
- If you are already subject to an internal risk-management regime under other Union law, for example as a provider of a device covered by Annex I harmonisation legislation, you may combine this risk management system with your existing one rather than running two.
These lines are LexLint's reading of the law's text.
In the frameworks
- NIST AI RMF
- GOVERN 1.4The risk management process and its outcomes are established through transparent policies, procedures, and other controls based on organizational risk priorities.
- MAP 5.1Likelihood and magnitude of each identified impact (both potentially beneficial and harmful) based on expected use, past uses of AI systems in similar contexts, public incident reports, feedback from those external to the team that developed or deployed the AI system, or other data are identified and documented.
- MEASURE 2.3AI system performance or assurance criteria are measured qualitatively or quantitatively and demonstrated for conditions similar to deployment setting(s). Measures are documented.
- MANAGE 1.3Responses to the AI risks deemed high priority, as identified by the MAP function, are developed, planned, and documented. Risk response options can include mitigating, transferring, avoiding, or accepting.
- NIST AI 600-1
- GAI-RISK-07Human-AI Configuration
- NIST AI 200-2 Draft
- OWASP LLM Top 10
- LLM03:2026Excessive Agency
- OWASP Agentic Top 10
- ASI09Human-Agent Trust Exploitation
- MIT mitigations Draft
- FINOS AIGF
- AIR-PREV-005System Acceptance Testing
- AIR-PREV-006Data Quality & Classification/Sensitivity
- AIR-PREV-024Human-in-the-Loop Action Approval Gate
- AIR-DET-004AI System Observability
- AIR-DET-011Human Feedback Loop for AI Systems
- AIR-DET-021Agent Decision Audit and Explainability
- ETSI EN 304 223
- 5.1.4-1Capability for human oversight designed in and maintained.
- 5.2.1-1Full inventory of assets, including their dependencies and connections.
- 5.2.4-1Developers keep an audit trail of system design and post-deployment maintenance plans and offer it downstream.
- 5.4.2-1Operators log system and user actions.
Our reading of where this law's duties sit in each framework, and in the NIST AI RMF, line by line beside each duty above. It never says that running a control meets the law. How we read a framework against the law
Identifiers refer to ETSI EN 304 223 V2.1.1 (2025-12), © ETSI 2025, all rights reserved. ETSI owns the standard; no ETSI text (titles or sentences) is reproduced here. The standard is free to download from ETSI.
If you get it wrong
Private right of actionNo
Penalty structure
Article 99(4)(a): non-compliance with the obligations of providers under Article 16 is fined up to EUR 15,000,000 or 3% of worldwide annual turnover, whichever is higher. Article 16, point (a), requires a provider to ensure its high-risk AI system complies with the Section 2 requirements this row states; brought in by Article 16, point (a)'s reference to Section 2, which covers the Article 9 risk management system; Article 99(6) requires the lower of the two amounts for an SME, including a start-up; Article 99(6a), inserted by Regulation (EU) 2026/1744, gives the same lower-of treatment to a small mid-cap enterprise, since both apply to paragraph 4 fines.
- Rule
- Lower of for SME
- As of
- Currency
- EUR
- Fixed cap
- 15,000,000
- Turnover percentage cap
- 3
Who enforces it
Settledness
- As of
- Open questions
- Which risks are ones that 'may be reasonably mitigated or eliminated through the development or design' of a high-risk AI system under Article 9(3), where a risk arises only from the way a deployer uses the system?
- What residual risk is 'judged to be acceptable' under Article 9(5), and by whom is that judgment tested?
What it makes you log
What the log must hold
Decision basis
Logging duty
Article 9 requires the risk management system itself to be established, implemented, documented and maintained as a continuous process with regular review and updating. It does not use the words logs, records or audit trail, so the duty is read as implicit rather than explicit: a system that must be documented and kept up to date cannot be shown to exist without some record of what was done and when. What that documentation must contain in full, and who may see it, are Article 11's technical documentation requirement and Article 21(1)'s access duty, each set out in its own article.
- Kind
- Implicit
- As of
- Provision
- Article 9(1) and 9(2)
- Trigger
- high_risk_systems
Also on the record
EEA status
- Status
- Pending
- Source link
- https://www.efta.int/eea-lex/32024r1689
What this law does
Providers of a high-risk AI system must establish, implement, document and maintain a risk management system for it, run as a continuous process across the system's whole lifecycle with regular review and updating, covering the identification and analysis of known and reasonably foreseeable risks to health, safety or fundamental rights, the estimation and evaluation of risks under intended use and reasonably foreseeable misuse, the evaluation of other risks surfaced by post-market monitoring, and the adoption of targeted risk management measures for the risks identified.
Those measures must bring residual risk, per hazard and overall, to an acceptable level, first by eliminating or reducing risk through design and development where technically feasible, then by mitigating what cannot be eliminated, then by providing required information and, where appropriate, deployer training, taking the deployer's likely expertise and context of use into account.
The system must be tested throughout development and, in any event, before it is placed on the market or put into service, against pre-defined metrics and probabilistic thresholds, to confirm the measures work and the system performs consistently for its intended purpose, and testing may draw on real-world testing under Article 60.
A provider must also consider whether the system is likely to adversely affect persons under 18 or other vulnerable groups when implementing this process, and a provider already bound by an internal risk-management regime under other Union law, for example as a manufacturer of a device under Annex I harmonisation legislation, may combine this risk management system with the existing one rather than running two.
Article 9 sits in Chapter III, Section 2, so it takes effect on the schedule the Digital Omnibus on AI (Regulation (EU) 2026/1744, in force since ) wrote into Article 113: for a system classified as high-risk under Article 6(2) and Annex III, and for a system classified as high-risk under Article 6(1) and Annex I, rather than the Regulation's general application date.
Under Article 111(2), as the Digital Omnibus on AI rewrote it, the Regulation reaches the operators of a high-risk AI system placed on the market or put into service before the date Chapter III applies only if, from that date, the system's design changes significantly; in any case, the providers and deployers of a high-risk AI system intended to be used by public authorities must take the necessary steps to comply with the Regulation's requirements and obligations by .
Article 9 does not apply to a high-risk AI system related to a product covered by the Union harmonisation legislation listed in Section B of Annex I, to which, under Article 2(2), only Article 6(1), Article 60a and Articles 102 to 112 apply, and Articles 57, 58 and 59 apply only in so far as the requirements for high-risk AI systems under this Regulation have been integrated in that Union harmonisation legislation.
When LexLint raises it
When your app profile says your app makes high-risk automated decisions.
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