Obligations of providers of high-risk AI systems

Providers of high-risk AI systems shall:

1. a.

   ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;¶

   High-Risk AI Classification Annex III Amendments AI Risk Assessment
2. b.

   indicate on the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, as applicable, their name, registered trade name or registered trade mark, the address at which they can be contacted;¶

   High-Risk AI Classification Artificial Intelligence
3. c.

   have a quality management system in place which complies with Article 17;¶

   Quality Management Provider Obligations for AI Systems
4. d.

   keep the documentation referred to in Article 18;¶

5. e.

   when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 19;¶

   High-Risk AI Classification Annex III Amendments AI Risk Assessment
6. f.

   ensure that the high-risk AI system undergoes the relevant conformity assessment procedure as referred to in Article 43, prior to its being placed on the market or put into service;¶

   High-Risk AI Classification Artificial Intelligence Conformity Assessment for AI Systems
7. g.

   draw up an EU declaration of conformity in accordance with Article 47;¶

   Conformity Assessment for AI Systems Provider Obligations for AI Systems AI Conformity Declaration
8. h.

   affix the CE marking to the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, to indicate conformity with this Regulation, in accordance with Article 48;¶

   High-Risk AI Classification Artificial Intelligence Provider Obligations for AI Systems
9. i.

   comply with the registration obligations referred to in Article 49(1);¶

   AI Registration
10. j.

    take the necessary corrective actions and provide information as required in Article 20;¶

    Corrective Actions and Duty of Information Framework Post-Market Monitoring for AI Systems Monitoring Actions under AI Act
11. k.

    upon a reasoned request of a national competent authority, demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2;¶

    High-Risk AI Classification Artificial Intelligence Public Authority
12. l.

    ensure that the high-risk AI system complies with accessibility requirements in accordance with Directives (EU) 2016/2102 and (EU) 2019/882.¶

    High-Risk AI Classification Artificial Intelligence