To ensure legal certainty, it is necessary to clarify that, under certain specific conditions, any natural or legal person should be considered a provider of a new high-risk AI system and therefore assume all the relevant obligations. For example, this would be the case if that person puts its name or trademark on a high-risk AI system already placed on the market or put into service, or if that person modifies the intended purpose of an AI system which is not high-risk and is already placed on the market or put into service, in a way that makes the modified system a high-risk AI system. These provisions should apply without prejudice to more specific provisions established in certain New Legislative Framework sectorial legislation with which this Regulation should apply jointly. For example, Article 16, paragraph 2 of Regulation 745/2017, establishing that certain changes should not be considered 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.
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