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Article 16

Obligations of Providers of High-Risk AI Systems

Updated on May 8th 2024 based on the version and article numbering in the EU Parliament's 'Corrigendum' version dated April 19th 2024.

Providers of high-risk AI systems shall:

  1. ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;
  2. 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;
  3. have a quality management system in place which complies with Article 17;
  4. keep the documentation referred to in Article 18;
  5. when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 19;
  6. 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;
  7. draw up an EU declaration of conformity in accordance with Article 47;
  8. 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;
  9. comply with the registration obligations referred to in Article 49(1);
  10. take the necessary corrective actions and provide information as required in Article 20;
  11. 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;
  12. ensure that the high-risk AI system complies with accessibility requirements in accordance with Directives (EU) 2016/2102 and (EU) 2019/882.

[Previous version]

Updated on April 10th 2024 based on the version and article numbering approved by the EU Parliament on March 13th 2024.

Providers of high-risk AI systems shall:

  1. ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;
  2. 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;
  3. have a quality management system in place which complies with Article 17;
  4. keep the documentation referred to in Article 18;
  5. when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 19;
  6. 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;
  7. draw up an EU declaration of conformity in accordance with Article 47;
  8. 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;
  9. comply with the registration obligations referred to in Article 49(1);
  10. take the necessary corrective actions and provide information as required in Article 20;
  11. 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;
  12. ensure that the high-risk AI system complies with accessibility requirements in accordance with Directives (EU) 2016/2102 and (EU) 2019/882.

Updated on Feb 6th 2024 based on the version endorsed by the Coreper I on Feb 2nd

Providers of high-risk AI systems shall:

  1. ensure that their high-risk AI systems are compliant with the requirements set out in Chapter 2 of this Title;

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

  1. have a quality management system in place which complies with Article 17;
  2. keep the documentation referred to in Article 18;
  3. when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 20;
  4. ensure that the high-risk AI system undergoes the relevant conformity assessment procedure as referred to in Article 43, prior to its placing on the market or putting into service;
    ea. draw up an EU declaration of conformity in accordance with Article 48;
    eb. affix the CE marking to the high-risk AI system to indicate conformity with this Regulation, in accordance with Article 49;
  5. comply with the registration obligations referred to in Article 51(1);
  6. take the necessary corrective actions and provide information as required in Article 21;
  7. upon a reasoned request of a national competent authority, demonstrate the conformity of the high-risk AI system with the requirements set out in Chapter 2 of this Title;

    ja. ensure that the high-risk AI system complies with accessibility requirements, in accordance with Directive 2019/882 on accessibility requirements for products and services and Directive 2016/2102 on the accessibility of the websites and mobile applications of public sector bodies.

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