Article 16
Obligations of providers and deployers of high-risk AI systems and other parties [This change has been provisionally agreed with the EP at the technical level.]

 

Providers of high-risk AI systems shall:

(a) ensure that their high-risk AI systems are compliant with the requirements set out in Chapter 2 of this Title before placing them on the market or putting them into service; [This clause has been provisionally agreed with the EP at the technical level. ]

(aa) indicate their name, registered trade name or registered trade mark, and their address and contact information on the high-risk AI system or, where that is not possible, on its accompanying documentation, as appropriate; [This clause has been provisionally agreed with the EP at the technical level. ]

(ab) ensure that natural persons to whom human oversight of high-risk AI systems is assigned are specifically made aware of the risk of automation or confirmation bias; [This clause has been provisionally agreed subject to final check by the EP.]

(ac) provide specifications for the input data, or any other relevant information in terms of the datasets used, including their limitation and assumptions, taking into account the intended purpose and the foreseeable and reasonably foreseeable misuses of the AI system; [This clause has been provisionally agreed subject to final check by the EP.]

(b) have a quality management system in place which complies with Article 17;

(c) draw-up and keep the technical documentation of the high-risk AI system referred to in Article 11; [This clause has been provisionally agreed subject to final check by the EP.]

(d) when under their control, keep the logs automatically generated by their high-risk AI systems that are required for ensuring and demonstrating compliance with this Regulation, in accordance with Article 20; [This clause has been provisionally agreed with the EP at the technical level. ]

(e) ensure that the high-risk AI system undergoes the relevant conformity assessment procedure, prior to its placing on the market or putting into service in accordance with Article 43 ; [This clause has been provisionally agreed with the EP at the technical level. ]

ea) draw up an EU declaration of conformity in accordance with Article 48; [This clause has been provisionally agreed with the EP at the technical level. ]

(eb) affix the CE marking to the high-risk AI system to indicate conformity with this Regulation, in accordance with Article 49; [This clause has been provisionally agreed with the EP at the technical level. ]

(f) comply with the registration obligations referred to in Article 51;

(g) take the necessary corrective actions  [;if the high-risk AI system is not in conformity with the requirements set out in Chapter 2 of this Title] ; as referred to in Article 21 and provide information in that regard; [This clause has been provisionally agreed subject to final check by the EP.]

(h) [] [/]inform the national competent authorities of the Member States in which they made the AI system available or put it into service and, where applicable, the notified body of the non-compliance and of any corrective actions taken; [This deletion has been provisionally agreed subject to final check by the EP.]

(i) to affix the CE marking to their high-risk AI systems to indicate the conformity with this Regulation in accordance with Article 49; [This deletion has been provisionally agreed with the EP at the technical level.]

(j) upon a reasoned request of a national [competentsupervisory authority, demonstrate the conformity of the high-risk AI system with the requirements set out in Chapter 2 of this Title.

(ja) ensure that the high-risk AI system complies with accessibility requirements. [This clause has been provisionally agreed with the EP at the technical level.]