(47) AI systems could have an adverse impact on the health and safety of persons, in particular when such systems operate as safety components of products. Consistent with the objectives of Union harmonisation legislation to facilitate the free movement of products in the internal market and to ensure that only safe and otherwise compliant products find their way into the market, it is important that the safety risks that may be generated by a product as a whole due to its digital components, including AI systems, are duly prevented and mitigated. For instance, increasingly autonomous robots, whether in the context of manufacturing or personal assistance and care should be able to safely operate and performs their functions in complex environments. Similarly, in the health sector where the stakes for life and health are particularly high, increasingly sophisticated diagnostics systems and systems supporting human decisions should be reliable and accurate.
Recital 47: AI systems could have an adverse impact on the health
Recital 47, Regulation (EU) 2024/1689
High-risk 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.