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Recital 52: As regards stand-alone AI systems, namely high-risk AI systems other

Recital 52, Regulation (EU) 2024/1689

High-risk AI systems

(52) As regards stand-alone AI systems, namely high-risk AI systems other than those that are safety components of products, or that are themselves products, it is appropriate to classify them as high-risk if, in light of their intended purpose, they pose a high risk of harm to the health and safety or the fundamental rights of persons, taking into account both the severity of the possible harm and its probability of occurrence and they are used in a number of specifically pre-defined areas specified in this Regulation. The identification of those systems is based on the same methodology and criteria envisaged also for any future amendments of the list of high-risk AI systems that the Commission should be empowered to adopt, via delegated acts, to take into account the rapid pace of technological development, as well as the potential changes in the use of AI systems.

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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.