Updated on 31 July 2024 based on the version published in the Official Journal of the EU dated 12 July 2024 and entered into force on 1 August 2024.

To ensure legal certainty, it is necessary to clarify that, under certain specific conditions, any distributor, importer, deployer or other third-party should be considered to be a provider of a high-risk AI system and therefore assume all the relevant obligations. This would be the case if that party puts its name or trademark on a high-risk AI system already placed on the market or put into service, without prejudice to contractual arrangements stipulating that the obligations are allocated otherwise. This would also be the case if that party makes a substantial modification to a high-risk AI system that has already been placed on the market or has already been put into service in a way that it remains a high-risk AI system in accordance with this Regulation, or if it modifies the intended purpose of an AI system, including a general-purpose AI system, which has not been classified as high-risk and has already been placed on the market or put into service, in a way that the AI system becomes a high-risk AI system in accordance with this Regulation. Those provisions should apply without prejudice to more specific provisions established in certain Union harmonisation legislation based on the New Legislative Framework, together with which this Regulation should apply. For example, Article 16(2) of Regulation (EU) 2017/745, establishing that certain changes should not be considered to be modifications of a device that could affect its compliance with the applicable requirements, should continue to apply to high-risk AI systems that are medical devices within the meaning of that Regulation.