Sourceoftruth
#EU-ACT-ART-25|HIGH RISK
warningregulation

Article 25: Responsibilities Along the AI Value Chain

Official Statutory Text

Article 25 Responsibilities along the AI value chain 1. Any distributor , imp or ter , deployer or other third-party shall be considered to bea provider of a high-r isk AI system for the purposes of this Regulation and shall be subject to the obligations of the provider under Article 16, in any of the following circumstances: (a) they put their name or trademark on a high-r isk AI system already placed on the marketor put into service, without prejudice to contractual arrangements stipulating that the obligations are other wiseallocat ed; (b) they makea substantial modification to a high-r isk AI system that has already been placed on the marketor has already been put into service in suchaway that it remains a high-r isk AI system pursuant to Article 6; (c) they modify the intended purposeof an AI system, including ag eneral-purpose AI system, which has not been classified as high-r isk and has already been placed on the marketor put into service in suchaway that the AI system concerned becomes a high-r isk AI system in accordance with Article 6. 2. Where the circumstances referred to in paragraph 1 occur , the provider that initially placed the AI system on the marketor put it into service shall no longer be considered to bea provider of that specific AI system for the purposes of this Regulation. That initial provider shall closely cooperate with new providers and shall makeavailable the necessary information and provide the reasonably expected technical access and other assistance that are required for the fulf ilmentof the obligations setout in this Regulation, in particular regarding the compliance with the conformity assessmentof high-r isk AI systems. This paragraph shall not apply in cases where the initial provider has clearly specified that its AI system is not to be changed into a high-r isk AI system and therefore does not fall under the obligation to hand over the documentation. 3. In the caseof high-r isk AI systems that are safety components of products covered by the Union harmonisation legislation listed in Section A of Annex I, the product manufacturer shall be considered to be the provider of the high-r isk AI system, and shall be subject to the obligations under Article 16 under either of the following circumstances: (a) the high-r isk AI system is placed on the market together with the product under the name or trademark of the product manufacturer; (b) the high-r isk AI system is put into service under the name or trademark of the product manufacturer after the product has been placed on the market. 4. The provider of a high-r isk AI system and the third party that supplies an AI system, tools, services, components, or processes that are used or integrated in a high-r isk AI system shall, by written agreement, specify the necessary information, capabilities, technical access and other assistance based on the generally acknowledged stateof thear t, in order to enable the provider of the high-r isk AI system tofully comply with the obligations setout in this Regulation. This paragraph shall not apply to third par ties making accessible to the public too ls, services, processes, or components, other than g eneral-purpose AI models, under a freeand open-source licence. The AI Office may develop and recommend voluntary model terms for contracts between providers of high-r isk AI systems and third par ties that supply tools, services, components or processes that are used for or integrated into high-r isk AI systems. When developing those voluntary model terms, the AI Office shall take into account possible contractual requirements applicable in specific sectors or business cases. The voluntary model terms shall be published and beavailable freeof charge in an easily usable electronic for mat. 5. Paragraphs 2 and 3 are without prejudice to the need to observeand protect intellectual property rights, confidential business information and trade secrets in accordance with Uni on and national law .

Legal Authority

European Parliament & Council (Regulation 2024/1689)

View Official EUR-Lex Publication
Mandatory Statutory Checklist & Fix
  • Be aware of re-classification as a provider: Any distributor, importer, deployer, or other third party will be considered a provider (and subject to Article 16 obligations) if they:
    • Put their name or trademark on an already placed/serviced high-risk AI system (unless contractual arrangements stipulate otherwise).
    • Make a substantial modification to an already placed/serviced high-risk AI system, such that it remains high-risk.
    • Modify the intended purpose of a non-high-risk AI system (including GPAI) already placed/serviced, making it a high-risk AI system per Article 6.
  • If you are an initial provider whose system is re-classified: Cooperate closely with the new provider and make available necessary information, technical access, and assistance for compliance, unless you clearly specified the AI system is not to be changed into a high-risk system.
  • For product manufacturers: If your high-risk AI system is a safety componentof a product covered by Union harmonisation legislation (Annex I, Section A), you will be considered the provider (and subject to Article 16 obligations) if the AI system is placed on the marketor put into service with/under your name or trademark.
  • Establish written agreements: Providers of high-risk AI systems and third parties supplying AI systems, tools, services, components, or processes used/integrated into a high-risk AI system must, by written agreement, specify the necessary information, capabilities, technical access, and assistance to enable the provider tofully comply with the Regulation (does not apply tofree and open-source tools/services/components other than general-purpose AI models).
  • Observe and protect intellectual property rights, confidential business information, and trade secrets in accordance with Union and national law.
Statutory Classification
HIGH RISK

Applies directly across all 27 EU Member States with phased entry into force from 2025 to 2026.