lexiara

Recital 22

Digital Omnibus on AI

(22) To streamline compliance and reduce associated costs, the registration of AI systems referred to in Article 6(3) of Regulation (EU) 2024/1689 in the EU database pursuant to Article 49(2) of that Regulation should be simplified by streamlining the content required under Annex VIII to that Regulation. While it remains crucial for effective market surveillance and public accountability that such AI systems are registered in the EU database, the registration requirements should be simplified and made more proportionate. This simplification would strike a better balance without undermining the protection laid down by Regulation (EU) 2024/1689. Such AI systems are not considered to be high risk under certain conditions where they do not pose a significant risk of harm to the health, safety or fundamental rights of persons. Furthermore, a provider applying Article 6(3) of Regulation (EU) 2024/1689 remains obligated to document its assessment before that AI system is placed on the market or put into service. National competent authorities should be able to request that assessment.

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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.