It is appropriate that, in order to minimise the burden on operators and avoid any possible duplication, for high-risk AI systems related to products which are covered by existing Union harmonisation legislation following the New Legislative Framework approach, the compliance of those AI systems with the requirements of this Regulation should be assessed as part of the conformity assessment already foreseen under that legislation. The applicability of the requirements of this Regulation should thus not affect the specific logic, methodology or general structure of conformity assessment under the relevant specific New Legislative Framework legislation. This approach is fully reflected in the interplay between this Regulation and the [Machinery Regulation]. While safety risks of AI systems ensuring safety functions in machinery are addressed by the requirements of this Regulation, certain specific requirements in the [Machinery Regulation] will ensure the safe integration of the AI system into the overall machinery, so as not to compromise the safety of the machinery as a whole. The [Machinery Regulation] applies the same definition of AI system as this Regulation. With regard to high-risk AI systems related to products covered by Regulations 745/2017 and 746/2017 on medical devices, the applicability of the requirements of this Regulation should be without prejudice and take into account the risk management logic and benefit-risk assessment performed under the medical device framework.
Please keep in mind that this form is only for feedback and suggestions for improvement.