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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.

Patterns that use this term

2 pattern pages use the term, most mentions first.

  • 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}
}