Chapter III · High-risk AI systems
Article 23 — Obligations of importers
Official text
Each paragraph records where its wording comes from. Only text reproduced unchanged from the Official Journal is authentic; consolidated text is editorial and has no legal value. Paragraphs, subparagraphs and points each have their own link.
Before placing a high-risk AI system on the market, importers shall ensure that the system is in conformity with this Regulation by verifying that:
- (a)
the relevant conformity assessment procedure referred to in Article 43 has been carried out by the provider of the high-risk AI system;
- (b)
the provider has drawn up the technical documentation in accordance with Article 11 and Annex IV;
- (c)
the system bears the required CE marking and is accompanied by the EU declaration of conformity referred to in Article 47 and instructions for use;
- (d)
the provider has appointed an authorised representative in accordance with Article 22(1).
Authentic — as published in the Official Journal
Where an importer has sufficient reason to consider that a high-risk AI system is not in conformity with this Regulation, or is falsified, or accompanied by falsified documentation, it shall not place the system on the market until it has been brought into conformity. Where the high-risk AI system presents a risk within the meaning of Article 79(1), the importer shall inform the provider of the system, the authorised representative and the market surveillance authorities to that effect.
Authentic — as published in the Official Journal
Importers shall indicate their name, registered trade name or registered trade mark, and the address at which they can be contacted on the high-risk AI system and on its packaging or its accompanying documentation, where applicable.
Authentic — as published in the Official Journal
Importers shall ensure that, while a high-risk AI system is under their responsibility, storage or transport conditions, where applicable, do not jeopardise its compliance with the requirements set out in Section 2.
Authentic — as published in the Official Journal
Importers shall keep, for a period of 10 years after the high-risk AI system has been placed on the market or put into service, a copy of the certificate issued by the notified body, where applicable, of the instructions for use, and of the EU declaration of conformity referred to in Article 47.
Authentic — as published in the Official Journal
Importers shall provide the relevant competent authorities, upon a reasoned request, with all the necessary information and documentation, including that referred to in paragraph 5, to demonstrate the conformity of a high-risk AI system with the requirements set out in Section 2 in a language which can be easily understood by them. For this purpose, they shall also ensure that the technical documentation can be made available to those authorities.
Authentic — as published in the Official Journal
Importers shall cooperate with the relevant competent authorities in any action those authorities take in relation to a high-risk AI system placed on the market by the importers, in particular to reduce and mitigate the risks posed by it.
Authentic — as published in the Official Journal
The formal analysis of Article 23
Article 6 is formalised first. The remaining articles follow.
Article 23 is formalised node by node: each rule as a deontic position with its operator, each exception with its rank, each predicate resolved against the definitions in Article 3.
What members get, per article
- the rule logic: every norm as a formal position, with the defeater chain that decides which exception wins
- the competency questions and their answers, every unanswered one marked as a gap and named
- the ontology: predicates bound to AISV (AI Standardisation Vocabulary) and to the definitions they depend on, exportable as JSON-LD and OWL
- the documentation: the Article 6(4) assessment record generated from a fact set, with its derivation and the version of the law it was decided against
Built for providers claiming the 6(3) derogation, for the counsel who has to defend that claim, and for the auditor who reads it afterwards.
Access is invite-only and opening in stages. Article 6 is formalised first; the remaining articles follow.
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Commentary in preparation
The official text above is complete. The editorial layer for this article — duties, the roles bound by them, the AISV concepts that model them, and the European standards written to support them — is in preparation, in the same form as the articles already published.
See the published articles