# Recital (84)

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 
and mobile applications of public sector bodies (OJ L 327, 2.12.2016, p. 1).

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.

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Source: Regulation (EU) 2024/1689 (Artificial Intelligence Act) as amended by Regulation (EU) 2026/1744, consolidated text of 27 July 2026 (Official Journal of the EU). This page is AI-generated legal information, not legal advice. Verify against the Official Journal.
Canonical: https://euaiactlaw.com/recital/84