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What is Conformity assessment?

Conformity assessment is the process of demonstrating that a high-risk AI system meets the requirements the EU AI Act sets for such systems. Depending on the system, the provider uses internal control or involves a notified body, and the result supports the declaration of conformity and CE marking.

Article 43 sets the routes. For most Annex III high-risk systems the provider can follow the internal control procedure without a notified body, while certain biometric systems have other options and products covered by sectoral law follow that law's procedure.

Source: Regulation (EU) 2024/1689 (the EU AI Act), EUR-Lex. Last reviewed 3 October 2026. General information, not legal advice.

See also

  • Notified body
  • CE marking (AI context)
  • Technical documentation
  • Provider

Go deeper

  • EU AI Act guide

← All AI governance terms

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