Article 16: Obligations of Providers of High-Risk AI Systems | EU AI Act

Article 16 of the AI Act contains essential information related to the responsibilities and obligations of providers of high-risk AI systems. Under this section, such providers must:

• Ensure their high-risk AI systems are compliant with the requirements set out in Section 2 of the AI Act, which are as follows:
  • Risk Management System,
  • Data Governance,
  • Technical Documentation,
  • Record-Keeping,
  • Transparency and Provision of Information to Deployers,
  • Human Oversight, and
  • Accuracy, Robustness and Cybersecurity;
• Ensure the high-risk AI system is appropriately labeled, either on its packaging or its accompanying documentation, having information such as the provider’s name, registered trade name or registered trademark, and the address at which they can be contacted;
• Have a compliant quality management system in place as per Article 17;
• Keep an updated set of necessary documentation as per Article 18;
• Ensure that the automated logs generated by their high-risk AI systems are appropriately kept as per Article 19;
• Ensure that the high-risk AI system goes through the relevant conformity assessment procedure, as referred to in Article 43 before being made available on the market or put into service;
• Draw up an EU declaration of conformity in accordance with Article 47;
• Comply with the relevant registration obligations as per Article 49(1);
• Take necessary corrective actions and provide the information required under Article 20 of the AI Act to distributors, deployers, authorized representatives, importers, market surveillance authorities and notified bodies;
• Upon a reasoned request of the competent national authority, demonstrate the conformity of the high-risk AI system with the requirement set out in Section 2;
• Ensure that the high-risk AI system complies with the relevant accessibility requirements in accordance with Directive (EU) 2016/2102 on the accessibility of the websites and mobile applications of public sector bodies and Directive (EU) 2019/882 on accessibility requirements for products and services; and
• Ensure the high-risk AI system has the CE marking on the system itself, its packaging, or the accompanying documentation, as per Article 48, to indicate its conformity with the AI Act.