Establish a risk management system for high-risk AI
Download: JSON · MarkdownUnder EU AI Act, Article 9
What this label means
- Verified
- — a named reviewer opened the official source and confirmed the record; the date and the reviewer are shown.
- Pending review
- — linked to the official source and in the queue for a reviewer to confirm.
- Source-linked
- — linked to the official source, not yet confirmed by a reviewer.
On this page 9 sections
In brief
Establish a risk management system for high-risk AI is a legal requirement under the EU AI Act in the European Union (Article 9). It applies from 2 December 2027. The record carries 2 evidence examples and mappings to 2 frameworks. In practice: Set up a lifecycle risk register per high-risk system with test evidence and residual-risk acceptance.
- Instrument
- EU AI Act
- Jurisdiction
- European Union
- Nature
- Legal requirement
- Source reference
- Article 9
- Applies from
- 2 December 2027
- Who it binds
- Provider / developer
- Evidence examples
- 2
- Framework mappings
- ISO/IEC 42001:2023, NIST AI Risk Management Framework 1.0
- Controls that meet it
- 3
- Official source
- Open official text
- Verification
- Pending review · source-linked
What does it require?
Providers of high-risk AI systems must establish, implement, document and maintain a continuous, iterative risk-management system across the system's lifecycle: identifying known and reasonably foreseeable risks to health, safety and fundamental rights, estimating and evaluating risks including from reasonably foreseeable misuse, evaluating post-market data, and adopting targeted risk-management measures, with testing before placing on the market.
Practical action
Set up a lifecycle risk register per high-risk system with test evidence and residual-risk acceptance.
Who does it apply to?
Providers of AI systems classified as high-risk under Article 6.
- Actors
- Provider / developer
- Sectors
- Cross-sector / all sectors
Applies from:
Which controls meet this duty?
Satisfies: the control, operated properly, does the work the duty asks for. Supports: it contributes but the duty needs more. Each control page lists every other duty it serves, so work done once can be counted once.
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satisfiesProcessAI system owner · once per ai systemAI risk assessment and lifecycle risk register
Serves 12 recorded duties · evidence: AI system risk assessment, Per-system AI risk register, Residual-risk acceptance
Continuous lifecycle risk process with register, testing evidence and residual-risk acceptance.
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supportsTechnical measureQuality or testing lead · at launch and on material changeAccuracy, robustness, fairness and security testing
Serves 15 recorded duties · evidence: Pre-release test report, Test plan and acceptance criteria, Release test sign-off
Testing confirms that mitigations work.
-
supportsTechnical measureAI system owner · continuousPost-deployment monitoring and drift detection
Serves 10 recorded duties · evidence: Post-market monitoring plan, Monitoring dashboard or periodic monitoring report, Monitoring review decision
Post-market data feeds risk re-evaluation.
Templates that cover this duty
Generated from the records. Free · no account · links emailed to your work address. This duty is cited in each file with its source reference and a link back here.
- AI Risk Register (MIT AI Risk Repository taxonomy)
Register · XLSX · v4
- EU AI Act Role and Risk Classifier
Checklist · XLSX · v4
- AI Impact Assessment
Assessment · DOCX and XLSX · v5
- EU AI Act Article 50 Transparency Kit
Kit · DOCX and XLSX · v32
What evidence would a reviewer expect?
| Evidence | Type | Notes |
|---|---|---|
| Risk register and treatment plan | register | |
| Pre-market test reports | report |
Framework mappings
Original editorial crosswalks. They cite clause numbers only and reproduce no standard text; confidence reflects how direct the mapping is.
See every European Union duty mapped this way →
| Framework | Reference | Note | Confidence |
|---|---|---|---|
| ISO/IEC 42001:2023 | Clauses 6.1.2, 6.1.3, 8.2, 8.3 and Annex A controls on AI risk | Original editorial mapping. | high |
| NIST AI RMF 1.0 | MAP, MEASURE and MANAGE functions | The AI RMF's core functions map closely to Article 9's iterative process. | high |
Frequently asked questions
Is this a legal requirement?
Yes. It is a legal requirement under EU AI Act (Article 9).
Who must comply with this obligation?
Providers of AI systems classified as high-risk under Article 6.
When does this obligation apply?
It applies from 2 December 2027.
What evidence shows compliance?
A reviewer would expect: Risk register and treatment plan; Pre-market test reports.
Which frameworks map to this obligation?
It is mapped to ISO/IEC 42001:2023 Clauses 6.1.2, 6.1.3, 8.2, 8.3 and Annex A controls on AI risk, NIST AI Risk Management Framework 1.0 MAP, MEASURE and MANAGE functions. These are editorial crosswalks with a stated confidence, not official mappings.
Which controls satisfy this obligation?
AI risk assessment and lifecycle risk register; Accuracy, robustness, fairness and security testing; Post-deployment monitoring and drift detection.
What should an organisation do in practice?
Set up a lifecycle risk register per high-risk system with test evidence and residual-risk acceptance.
Cite this record
AIPolicyTracker (2026). “Establish a risk management system for high-risk AI (EU AI Act)” [AIPT-OBL-0006, not yet verified]. https://aipolicytracker.org/id/AIPT-OBL-0006 (accessed 27 October 2026). Data licensed CC BY 4.0.
Permanent id AIPT-OBL-0006: it never changes or gets reused, and its address keeps working if this page moves.
Cite the official text alongside it: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence, Official Journal of the European Union, https://eur-lex.europa.eu/eli/reg/2024/1689/oj.
BibTeX
@misc{aipolicytracker2026_establishariskmanagement,
author = {{AIPolicyTracker}},
title = {{Establish a risk management system for high-risk AI (EU AI Act)}},
year = {2026},
howpublished = {\url{https://aipolicytracker.org/obligations/eu-ai-act-risk-management-system}},
url = {https://aipolicytracker.org/obligations/eu-ai-act-risk-management-system},
urldate = {2026-10-27},
note = {Data licensed CC BY 4.0. Accessed 27 October 2026}
}
Change history
No change to this record's tracked fields has been recorded since 15 October 2026, when field-level history began.
Similar obligations in other instruments
- Deployers must implement a risk management policy and programme — Colorado AI Act, Colorado (United States)
- Deployers must use reasonable care to avoid algorithmic discrimination — Colorado AI Act, Colorado (United States)
- Apply minimum risk-management practices to high-impact AI — OMB M-25-21, United States
- Operators of high-impact AI must establish and operate a risk management plan — AI Basic Act, South Korea
- Developers must use reasonable care to avoid algorithmic discrimination — Colorado AI Act, Colorado (United States)
- Prioritise, respond to and monitor AI risks (Manage) — NIST AI RMF, United States (voluntary)
- Ensure AI systems are safe, secure and robust throughout their lifecycle — UK AI regulation framework, United Kingdom (voluntary)
Disclaimer: informational only, not legal advice. Verify every claim against the linked official sources and consult a qualified lawyer before acting.