Obligations of Providers of High-Risk AI Systems

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;
(b) have a quality management system in place pursuant to Article 17;
(c) draw up the technical documentation of the high-risk AI system;
(d) where applicable, follow the relevant conformity assessment procedure in accordance with Article 43;
(e) register themselves and their high-risk AI system in the EU database referred to in Article 71;
(f) take the necessary corrective actions and provide information as required pursuant to Article 20;
(g) affix the CE marking to their high-risk AI systems to indicate conformity with this Regulation in accordance with Article 48;
(h) upon request by a national competent authority, demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2.