Recital 20

(20) In accordance with Article 6(1) of Regulation (EU) 2024/1689, AI systems are classified as high-risk where an AI system that is a component of a product covered by Union harmonisation legislation listed in Section A of Annex I to that Regulation is a safety component and that product requires a third-party conformity assessment. The requirement that such product must require a third-party conformity assessment, however, does not affect the choice of the manufacturer regarding the conformity assessment procedure for such product. Where Union harmonisation legislation listed in Section A of Annex I allows to choose a conformity assessment procedure based on harmonised standards amongst conformity assessment procedures, this possibility remains applicable also to products in which a high-risk AI system is embedded. Article 6(1) of Regulation (EU) 2024/1689 should not be understood to require products in which a high-risk AI system is embedded to automatically undergo a third-party conformity assessment involving a notified body. Where this possibility is provided for in Union harmonisation legislation, the provider of the product in which the high-risk AI system is embedded could continue to rely on harmonised standards to comply with the requirements of the Union harmonisation legislation and Regulation (EU) 2024/1689 as a conformity assessment procedure.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-14 · Text as adopted (Official Journal); later amendments are not incorporated in this text.