(125) Given the complexity of high-risk AI systems and the risks that are associated with them, it is important to develop an adequate conformity assessment procedure for high-risk AI systems involving notified bodies, so-called third party conformity assessment. However, given the current experience of professional pre-market certifiers in the field of product safety and the different nature of risks involved, it is appropriate to limit, at least in an initial phase of application of this Regulation, the scope of application of third-party conformity assessment for high-risk AI systems other than those related to products. Therefore, the conformity assessment of such systems should be carried out as a general rule by the provider under its own responsibility, with the only exception of AI systems intended to be used for biometrics.
Recital 125: Given the complexity of high-risk AI systems and the risks
Recital 125, Regulation (EU) 2024/1689
High-risk AI systemsNotified bodyProvider
Implementing this provision is a skill, not a lookup.
The EU AI Act Implementation Expert program teaches the working practice behind every article: classification, conformity, documentation, and the judgment to defend your decisions.
Mechanically consolidated from the official OJ texts of Regulations (EU) 2024/1689 and 2026/1744 (the Digital Omnibus, in force 27 July 2026); unofficial pending the official EUR-Lex consolidation. Study aid, not legal advice; the official texts on EUR-Lex are authoritative.