Article 16

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

Providers of high-risk AI systems shall:
(a) ensure that their high-risk AI systems are compliant with the requirements set out in Section 2 of this Chapter;
(b) 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;
(c) have a quality management system in place in accordance with Article 17;
(d) keep the documentation as referred to in Article 18;
(e) when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 19;
(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;
(g) draw up the EU declaration of conformity in accordance with Article 47;
(h) affix the CE marking of conformity in accordance with Article 48;
(i) comply with the registration obligations referred to in Article 49;
(j) take the necessary corrective actions and provide information as required pursuant to Article 20;
(k) upon request of a national competent authority, demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2 of this Chapter;
(l) ensure the high-risk AI system bears a contact point for communication with deployers.