1With a view to ensuring the smooth application and consistency of Regulation (EU) 2024/1689, amendments should be made to it. 2A technical correction to Article 43(3), first subparagraph, of Regulation (EU) 2024/1689 should be made to align the conformity assessment requirements with the requirements of providers of high-risk AI systems in Article 16 of that Regulation. 3Moreover, it should be clarified that where a provider of a high-risk AI system is subject to the conformity assessment procedure under Union harmonisation legislation listed in Section A of Annex I to Regulation (EU) 2024/1689, and the conformity assessment extends to the compliance of the quality management system of that Regulation and of such Union harmonisation legislation, the provider should be able to include aspects related to quality management systems pursuant to that Regulation as part of the quality management systems pursuant to such Union harmonisation legislation, in accordance with Article 17(3) of Regulation (EU) 2024/1689. 4Article 43(3), second subparagraph, of that Regulation should be amended to clarify that notified bodies which have been notified pursuant to the Union harmonisation legislation listed in Section A of Annex I to Regulation (EU) 2024/1689 and which aim to assess high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I to that Regulation, should have the power to assess the conformity of high-risk AI systems under certain conditions for 18 months from 27 July 2026. 5This amendment is without prejudice to Article 28 of Regulation (EU) 2024/1689, thus conformity assessment bodies that wish to be designated and notified pursuant to that Regulation can submit an application at any time during and after these 18 months. 6Moreover, Regulation (EU) 2024/1689 should be amended to clarify that where a high-risk AI system is both covered by the Union harmonisation legislation listed in Section A of Annex I to Regulation (EU) 2024/1689 and falls within one of the use-cases listed in Annex III to that Regulation, the provider should follow the relevant conformity assessment procedure as required under that relevant harmonisation legislation.
* This title is an unofficial description.