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Conformity assessment

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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 systems, a notified body for some biometric systems, and the sectoral procedure for Annex I products 1. It precedes the declaration, CE marking and registration.

Developed in
ch. 18, Conformity assessment, declaration, marking and registration
ch. 14, EU AI Act conformity, in order
Chapters
ch. 14, Development · ch. 18, EU AI Act
Source
1 numbered reference, listed below

Where it is used

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

  • CE marking

    The mark showing a high-risk AI system's conformity with the EU AI Act, affixed visibly, legibly and indelibly, or digitally for systems provided digitally…

  • 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…

  • Notified body

    A conformity assessment body designated under the EU AI Act to carry out third-party conformity assessment of high-risk AI systems.

  • Substantial modification

    Under the EU AI Act, a change after placing on the market that the initial conformity assessment did not foresee and that affects compliance or changes the…

  • Pre-determined changes

    Changes to a high-risk system that continues to learn, planned by the provider at the initial conformity assessment and described in the technical…

  • Placing on the market

    Under the EU AI Act, the first making available of an AI system or general-purpose AI model on the Union market; later supplies in the course of a commercial…

  • Annex I (EU AI Act)

    The AI Act annex listing the Union harmonisation legislation under which AI is embedded in regulated products (machinery, medical devices, toys and the like)…

  • High-risk AI system

    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…

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). Conformity assessment. In AI Governance Engineering: The Thesis & Body of Knowledge (v0.5.0), Glossary. https://doi.org/10.5281/zenodo.22956197. https://aigovernanceengineer.com/glossary/conformity-assessment. CC BY 4.0

BibTeX

@misc{aige2026conformityassessment,
  author  = {Jorge García Aibar},
  title   = {{Conformity assessment}},
  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/conformity-assessment}
}