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Recitals
Chapter I: General Provisions
Chapter II: Prohibited AI Practices
Chapter III: High-Risk AI Systems

Section 1: Classification of AI Systems as High-Risk

Section 2: Requirements for High-Risk AI Systems

Section 3: Obligations of Providers and Deployers of High-Risk AI Systems and Other Parties

Section 4: Notifying Authorities and Notified Bodies

Section 5: Standards, Conformity Assessment, Certificates, Registration

Chapter IV: Transparency Obligations for Providers and Deployers of Certain AI Systems
Chapter V: General-Purpose AI Models
Chapter VI: Measures in Support of Innovation
Chapter VII: Governance
Chapter VIII: EU Database for High-Risk AI Systems
Chapter IX: Post-Market Monitoring, Information Sharing and Market Surveillance

Section 1: Post-Market Monitoring

Section 2: Sharing of Information on Serious Incidents

Section 3: Enforcement

Section 4: Remedies

Section 5: Supervision, Investigation, Enforcement and Monitoring in Respect of Providers of General-Purpose AI Models

Chapter X: Codes of Conduct and Guidelines
Chapter XI: Delegation of Power and Committee Procedure
Chapter XII: Penalties
Chapter XIII: Final Provisions
Annexes
  • Chapter III: High-Risk AI Systems
  • Section 3: Obligations of Providers and Deployers of High-Risk AI Systems and Other Parties

Article 23: Obligations of importers

Summary

Before placing a high-risk AI system on the market, importers must verify that the system complies with the AI Act, including conformity assessments, technical documentation, CE marking accompanied by the EU declaration of conformity, and the appointment of an authorised representative. If an importer suspects non-compliance or falsification, they must not place the AI system on the market and must inform the provider, representative, and authorities. Importers must indicate their contact details on the system, ensure proper storage and transport conditions, and keep records for 10 years. They must also cooperate with authorities, providing necessary information and documentation upon request.

The summaries are meant to provide helpful explanation but are not legal binding.

1.   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).

2.   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.

3.   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.

4.   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.

5.   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.

6.   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.

7.   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.

Relevant recitals