To mitigate the risks from high-risk AI systems placed on the market or put into service and to ensure a high level of trustworthiness, certain mandatory requirements should apply to high risk AI systems, taking into account the intended purpose and the context of use of the AI system and according to the risk management system to be established by the provider. The measures adopted by the providers to comply with the mandatory requirements of this Regulation should take into account the generally acknowledge state of the art on artificial intelligence, be proportionate and effective to meet the objectives of this Regulation. Following the New Legislative Framework approach, as clarified in Commission notice the ‘Blue Guide’ on the implementation of EU product rules 2022 (C/2022/3637), the general rule is that several pieces of the EU legislation may have to be taken into consideration for one product, since the making available or putting into service can only take place when the product complies with all applicable Union harmonisation legislation. Hazards of AI systems covered by the requirements of this Regulation concern different aspects than the existing Union harmonisation acts and therefore the requirements of this Regulation would complement the existing body of the Union harmonisation acts. For example, machinery or medical devices products incorporating an AI system might present risks not addressed by the essential health and safety requirements set out in the relevant Union harmonised legislation, as this sectoral legislation does not deal with risks specific to AI systems. This calls for a simultaneous and complementary application of the various legislative acts. To ensure consistency and avoid unnecessary administrative burden or costs, providers of a product that contains one or more high-risk artificial intelligence system, to which the requirements of this Regulation as well as requirements of the Union harmonisation legislation listed in Annex II, Section A apply, should have a flexibility on operational decisions on how to ensure compliance of a product that contains one or more artificial intelligence systems with all applicable requirements of the Union harmonised legislation in a best way. This flexibility could mean, for example a decision by the provider to integrate a part of the necessary testing and reporting processes, information and documentation required under this Regulation into already existing documentation and procedures required under the existing Union harmonisation legislation listed in Annex II, Section A. This however should not in any way undermine the obligation of the provider to comply with all the applicable requirements.