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Article 16

Obligations of Providers of High-Risk AI Systems

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 trademark, 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;
  1. keep the documentation referred to in Article 18;
  1. when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 20;
  1. 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;
  1. comply with the registration obligations referred to in Article 51(1);
  1. take the necessary corrective actions as referred to in Article 21, if the high-risk AI system is not in conformity with the requirements set out in Chapter 2 of this Title;
  1. inform the relevant national competent authority of the Member States in which they made the AI system available or put it into service and, where applicable, the notified body of the non-compliance and of any corrective actions taken;
  1. to affix the CE marking to their high-risk AI systems to indicate the conformity with this Regulation in accordance with Article 49;
  1. upon 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.
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