AI Act
Table of Contents
Chapter I – GENERAL PROVISIONS
Chapter II – PROHIBITED AI PRACTICES
Chapter III – HIGH-RISK AI SYSTEMS
Chapter IV – TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND DEPLOYERS OF CERTAIN AI SYSTEMS
Chapter V – GENERAL-PURPOSE AI MODELS
Chapter VI – MEASURES IN SUPPORT OF INNOVATION
Chapter VII – GOVERNANCE
Chapter VIII – EU DATABASE FOR HIGH-RISK AI SYSTEMS
Chapter IX – POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE
Chapter X – CODES OF CONDUCT AND GUIDELINES
Chapter XI – DELEGATION OF POWER AND COMMITTEE PROCEDURE
Chapter XII – PENALTIES
Chapter XIII – FINAL PROVISIONS
Recitals (180)
Annexes
Chapter III – 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) indicate on the high-risk 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, the address at which they can be contacted;
(c) have a quality management system in place which complies with Article 17;
(d) keep the documentation 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 an EU declaration of conformity in accordance with Article 47;
(h) affix the CE marking to the high-risk 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 referred to in Article 49(1);
(j) take the necessary corrective actions and provide information as required in Article 20;
(k) upon a reasoned request of a national competent authority, demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2;
(l) ensure that the high-risk AI system complies with accessibility requirements in accordance with Web Accessibility Directive and (EU) 2019/882.