Article 16: Obligations of Providers of High-Risk AI Systems

Official Statutory Text

Article 16 Obligations of providers of high-r isk AI systems Providers of high-r isk AI systems shall: (a) ensure that their high-r isk AI systems are compliant with the requirements setout in Section 2; (b) indicate on the high-r isk 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 , theaddress at which they can be contacted; (c) havea quality management system in place which complies with Article 17; (d) keep the documentation refer red to in Article 18; (e) when under their control, keep the logs automatically generated by their high-r isk AI systems as referred to in Article 19; (f) ensure that the high-r isk AI system undergoes the relevant conformity assessment procedureas refer red to in Article 43, prior to its being placed on the mark etor put into service; (g) drawup an EU declaration of conformity in accordance with Article 47; (h) affix the CE marking to the high-r isk 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; (i) comply with the registration obligations refer red to in Article 49(1); (j) take the necessary correctiveactions and provide information as required in Article 20; (k) upon a reasoned requestof a national competent authority , demonstrate the conformity of the high-r isk AI system with the requirements setout in Section 2; (l) ensure that the high-r isk AI system complies with accessibility requirements in accordance with Directives (EU) 2016/2102 and (EU) 2019/882.