Article 45 — Information obligations of notified bodies
Digital & dataLevel 1RegulationAI ActIn forceOfficial source
45(1)(a)
(a)any Union technical documentation assessment certificates, any supplements to those certificates, and any quality management system approvals issued in accordance with the requirements of Annex VII;
Copy link45(1)(b)
(b)any refusal, restriction, suspension or withdrawal of a Union technical documentation assessment certificate or a quality management system approval issued in accordance with the requirements of Annex VII;
Copy link45(1)(d)
(d)any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
Copy link45(1)(e)
(e)on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
Copy link45(2)(a)
(a)quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued;
Copy link45(2)(b)
(b)Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.
Copy link45(3)Copy link
3.Each notified body shall provide the other notified bodies carrying out similar conformity assessment activities covering the same types of AI systems with relevant information on issues relating to negative and, on request, positive conformity assessment results.
45(4)Copy link
4.Notified bodies shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.