Article 45 Information obligations of notified bodies

1. 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;

2. 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;

3. any circumstances affecting the scope of or conditions for notification;

4. any request for information which they have received from market surveillance authorities means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; regarding conformity assessment means the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled; activities;

5. on request, conformity assessment means the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled; activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.

1. quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued;

2. Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.

Each notified body means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; shall provide the other notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; carrying out similar conformity assessment means the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled; activities covering the same types of AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; with relevant information on issues relating to negative and, on request, positive conformity assessment means the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled; results.

Notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.