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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

Section 1: Classification Rules

Section 2: Obligations for Providers of General-Purpose AI Models

Section 3: Obligations of Providers of General-Purpose AI Models with Systemic Risk

Section 4: Codes of Practice

Chapter VI: Measures in Support of Innovation
Chapter VII: Governance

Section 1: Governance at Union Level

Section 2: National competent authorities

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
Annex I
Annex II
Annex III
Annex IV
Annex V
Annex VI
Annex VII
Annex VIII
Annex IX
Annex X
Annex XI
Annex XII
Annex XIII
  • Chapter III: High-Risk AI Systems
  • Section 3: Obligations of Providers and Deployers of High-Risk AI Systems and Other Parties

Article 24: Obligations of distributors

Summary

Before distributing a high-risk AI system, distributors must verify it has the CE marking, EU declaration of conformity, and instructions for use, and that providers and importers have met their obligations. If a distributor suspects non-compliance, they must not release the system and must inform the provider or importer. Distributors must ensure proper storage and transport conditions and take corrective actions if they identify issues post-release, informing relevant parties and authorities. They must provide necessary information to authorities upon request and cooperate with them to mitigate risks.

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

1.   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).

2.   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.

3.   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.

4.   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.

5.   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.

6.   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.

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