AI Act Obligations for Distributors

Source text: “Before making a high-risk AI system available on the market, distributors shall verify that it bears the required CE marking, that it is accompanied by a copy of the EU declaration of conformity referred to in Article 47 and instructions for use, and that the provider and the importer of that system, as applicable, have complied with their respective obligations as laid down in Article 16, points (b) and (c) and Article 23(3).”

In practice: Distributors should establish a pre-distribution checklist that confirms CE marking presence, availability of the EU declaration of conformity (Article 47), instructions for use, and documented evidence that the provider has met Article 16(b)/(c) and the importer has met Article 23(3) obligations before any product is released to market.

Source text: “Where a distributor considers or has reason to consider, on the basis of the information in its possession, that a high-risk AI system is not in conformity with the requirements set out in Section 2, it shall not make the high-risk AI system available on the market until the system has been brought into conformity with those requirements. Furthermore, where the high-risk AI system presents a risk within the meaning of Article 79(1), the distributor shall inform the provider or the importer of the system, as applicable, to that effect.”

In practice: Distributors should implement a non-conformity escalation procedure: if any evidence of non-compliance is identified, immediately halt distribution and notify the provider or importer in writing, documenting the basis for the concern and any risk indicators under Article 79(1).

Source text: “Distributors shall ensure that, while a high-risk AI system is under their responsibility, storage or transport conditions, where applicable, do not jeopardise the compliance of the system with the requirements set out in Section 2.”

In practice: Distributors should document and enforce storage and transport protocols for high-risk AI systems, including environmental controls (temperature, humidity, physical security) and handling procedures, and verify these conditions are maintained throughout the distribution chain.

Source text: “A distributor that considers or has reason to consider, on the basis of the information in its possession, a high-risk AI system which it has made available on the market not to be in conformity with the requirements set out in Section 2, shall take the corrective actions necessary to bring that system into conformity with those requirements, to withdraw it or recall it, or shall ensure that the provider, the importer or any relevant operator, as appropriate, takes those corrective actions. Where the high-risk AI system presents a risk within the meaning of Article 79(1), the distributor shall immediately inform the provider or importer of the system and the authorities competent for the high-risk AI system concerned, giving details, in particular, of the non-compliance and of any corrective actions taken.”

In practice: Distributors should establish a product recall and corrective action procedure that includes immediate notification channels to both the provider/importer and relevant competent authorities, with templates for documenting non-compliance details and corrective measures taken, triggered automatically when a risk under Article 79(1) is identified.

Source text: “Upon a reasoned request from a relevant competent authority, distributors of a high-risk AI system shall provide that authority with all the information and documentation regarding their actions pursuant to paragraphs 1 to 4 necessary to demonstrate the conformity of that system with the requirements set out in Section 2.”

In practice: Distributors should maintain a comprehensive compliance dossier for each high-risk AI system they distribute, including records of pre-market verification, storage/transport conditions, and any corrective actions taken, so that this documentation can be promptly provided to competent authorities upon request.

Source text: “Distributors shall cooperate with the relevant competent authorities in any action those authorities take in relation to a high-risk AI system made available on the market by the distributors, in particular to reduce or mitigate the risk posed by it.”

In practice: Distributors should establish a clear internal process for responding to requests from market surveillance authorities, including designating a point of contact, maintaining records of distributed high-risk AI systems, and having documented risk-mitigation procedures ready to activate upon authority request.

Source text: “Any distributor, importer, deployer or other third-party shall be considered to be a provider of a high-risk 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:”

In practice: Organisations that rebrand, substantially modify, or repurpose AI systems should conduct a legal review before doing so to determine whether they will assume full provider obligations under Article 16. Document all modifications and purpose changes in writing.