AI Governance Engineer
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High-risk AI system

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Under the EU AI Act, an AI system that is a safety component of, or itself, a product under Annex I legislation needing third-party conformity assessment, or that is used in an Annex III area, unless the Article 6(3) filter applies. It carries the Articles 8 to 15 requirements and provider and deployer duties 1.

Developed in
ch. 18, The risk ladder
Chapters
ch. 18, EU AI Act
Contrast with
Prohibited practice · High-impact AI (Korea) · Risk tier
Source
1 numbered reference, listed below

Where it is used

3 chapters of the Body of Knowledge use the term. Each link opens the first section that does.

High-risk AI system: mentions per chapter3 mentions of the term across 3 of the 23 chapters of the Body of Knowledge; the chapters the glossary cross-references are drawn solid.Other chapterCross-referenced, not named08 Regulatory Map: 1 mention08 Regulatory Map110 Reading List: 1 mention10 Reading List115 Deployment: 1 mention15 Deployment118 EU AI Act0No mentions in the other 19 chaptersSource: the Body of Knowledgev0.5.0
High-risk AI system: mentions per chapter3 mentions of the term across 3 of the 23 chapters of the Body of Knowledge; the chapters the glossary cross-references are drawn solid.Other chapterCross-referenced, not named000102030405060708 Regulatory Map: 1 mention10810 Reading List: 1 mention1101112131415 Deployment: 1 mention1151617181920212223Source: the Body of Knowledge v0.5.0
Mentions per chapter How often each chapter names the term, with the chapters the glossary cross-references drawn solid. The longest bar is where to read the term in use; bars spread across many chapters mark a term that runs through the discipline.
Mentions as a table
Mentions of High-risk AI system per chapter
ChapterMentionsCross-referenced
00 Preface0No
01 Definition0No
02 Why Now0No
03 Values & Principles0No
04 The Stack0No
05 Patterns0No
06 The Role0No
07 Maturity Model0No
08 Regulatory Map1No
10 Reading List1No
11 AI Defined0No
12 Governance Program0No
13 Risk Management0No
14 Development0No
15 Deployment1No
16 Fairness & XAI0No
17 Incidents0No
18 EU AI Act0Yes
19 Privacy & AI0No
20 Existing Law0No
21 AI Laws Worldwide0No
22 Principles & Standards0No
23 AI Agents0No

Patterns that use this term

2 pattern pages use the term, most mentions first.

High-risk AI system: related terms and patternsThe term at the centre; related terms on solid edges, the terms it is contrasted with on dashed edges, and the patterns that use it most in the colour of their layer.RelatedContrastColour: stack layer of the pattern01 Govern-as-Code05 AssuranceHigh-risk AI systemRelated terms (5)Authorised representative · RelatedAuthorised representativeConformity assessment · RelatedConformity assessmentEU declaration of conformity · RelatedEU declaration of conformityInstructions for use · RelatedInstructions for useTechnical documentation (Annex IV) · RelatedTechnical documentationContrast with (3)High-impact AI (Korea) · ContrastHigh-impact AI (Korea)Prohibited practice · ContrastProhibited practiceRisk tier · ContrastRisk tierPatterns using it (2)Claims Substantiation Gate, 1 mention · Uses the termClaims Substantiation GateFRIA-as-Code, 1 mention · Uses the termFRIA-as-Code
High-risk AI system: related terms and patternsThe term at the centre; related terms on solid edges, the terms it is contrasted with on dashed edges, and the patterns that use it most in the colour of their layer.RelatedContrastColour: stack layer of the pattern01 Govern-as-Code05 AssuranceRelated terms (5)Authorised representative · RelatedAuthorised representativeConformity assessment · RelatedConformity assessmentEU declaration of conformity · RelatedEU declaration of conformityInstructions for use · RelatedInstructions for useTechnical documentation (Annex IV) · RelatedTechnical documentationContrast with (3)High-impact AI (Korea) · ContrastHigh-impact AI (Korea)Prohibited practice · ContrastProhibited practiceRisk tier · ContrastRisk tierPatterns using it (2)Claims Substantiation Gate, 1 mention · Uses the termClaims Substantiation GateFRIA-as-Code, 1 mention · Uses the termFRIA-as-CodeHigh-risk AIsystem
The term's neighbourhood Terms related to this one on solid edges, terms it is often confused with on dashed edges, and the patterns that use it most in the colour of their layer. Follow a dashed edge to check the distinction before you use either term.
Neighbourhood as a table
Neighbourhood of High-risk AI system
FamilyItemRelation
Related termsAuthorised representativeRelated
Related termsConformity assessmentRelated
Related termsEU declaration of conformityRelated
Related termsInstructions for useRelated
Related termsTechnical documentation (Annex IV)Related
Contrast withHigh-impact AI (Korea)Contrast
Contrast withProhibited practiceContrast
Contrast withRisk tierContrast
Patterns using itClaims Substantiation Gate, 1 mentionUses the term
Patterns using itFRIA-as-Code, 1 mentionUses the term
  • Technical documentation (Annex IV)

    The provider's technical file for a high-risk AI system, drawn up before placing on the market and kept up to date under Article 11: description, development…

  • EU declaration of conformity

    The provider's signed statement, following AI Act Annex V, that a high-risk AI system meets the Act's requirements; drawn up after the conformity assessment…

  • Authorised representative

    Under the EU AI Act, a person established in the Union with a written mandate from a non-EU provider of a high-risk AI system or general-purpose AI model to…

  • Conformity assessment

    The procedure by which a provider shows a high-risk AI system meets the EU AI Act before placing it on the market: internal control for most Annex III…

  • Instructions for use

    The information a provider of a high-risk AI system must give deployers: intended purpose, declared accuracy and robustness, known risks, how to read the…

Sources

  1. [1] Regulation (EU) 2024/1689 (AI Act), consolidated text as amended by Regulation (EU) 2026/1744 (Digital Omnibus on AI, in force 27 Jul 2026; definitions in Art. 3, incl. 3(1), 3(3) to 3(14), 3(14b), 3(20), 3(22), 3(23), 3(29) to 3(32), 3(49), 3(55) to 3(57), 3(60), 3(61), 3(63), 3(68); Arts. 4, 5, 6 (incl. 6(3) third subparagraph, profiling), 9, 10, 11, 13, 14, 15, 17, 22 to 27 (incl. 26(11)), 40, 41, 43, 47, 48, 50, 53 (incl. 53(1)(c)), 55, 57, 60, 72, 73, 86; Annexes I, III, IV). Publications Office of the EU (EUR-Lex). 2026-07-27. https://eur-lex.europa.eu/eli/reg/2024/1689/2026-07-27/eng (verified: primary)

Definitions of legal terms paraphrase the cited text, which governs. Dated statements are as of .

Cite this term

García Aibar, J. (2026). High-risk AI system. In AI Governance Engineering: The Thesis & Body of Knowledge (v0.5.0), Glossary. https://doi.org/10.5281/zenodo.22956197. https://aigovernanceengineer.com/glossary/high-risk-ai-system. CC BY 4.0

BibTeX

@misc{aige2026highriskaisystem,
  author  = {Jorge García Aibar},
  title   = {{High-risk AI system}},
  note    = {Glossary, AI Governance Engineering: The Thesis \& Body of Knowledge, version 0.5.0},
  year    = {2026},
  doi     = {10.5281/zenodo.22956197},
  url     = {https://aigovernanceengineer.com/glossary/high-risk-ai-system}
}