Artificial Intelligence Policy Tracker
Legal requirement AI risk management European Union Partially applicable

Establish a risk management system for high-risk AI

Download: JSON · MarkdownUnder EU AI Act, Article 9

Pending review · linked to the official source, waiting for a reviewer to confirm it (a factual check against the official source, not a legal review or legal advice)
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Verification policy and current standing · a factual check, not legal advice.
No change recorded as of 26 Sep 2026 · official source last checked
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.

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.

  • satisfiesProcessAI system owner · once per ai system
    AI 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.

  • supportsTechnical measureQuality or testing lead · at launch and on material change
    Accuracy, 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 · continuous
    Post-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.

All 9 templates that cover it →

What evidence would a reviewer expect?

Evidence examples
EvidenceTypeNotes
Risk register and treatment planregister
Pre-market test reportsreport

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 mappings table
FrameworkReferenceNoteConfidence
ISO/IEC 42001:2023Clauses 6.1.2, 6.1.3, 8.2, 8.3 and Annex A controls on AI riskOriginal editorial mapping.high
NIST AI RMF 1.0MAP, MEASURE and MANAGE functionsThe 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

Disclaimer: informational only, not legal advice. Verify every claim against the linked official sources and consult a qualified lawyer before acting.