Art. 45 Information obligations of notified bodies | AI act regulation | AI act

This article establishes the information-sharing and reporting obligations that sit on notified bodies — the third-party conformity assessment bodies that play a central role in certifying high-risk AI systems under the regulation.

It operates on two levels: reporting upward to the notifying authority, and sharing laterally with peer notified bodies.

The overall intent is to maintain transparency and consistency across the conformity assessment ecosystem, ensuring that decisions made by one notified body are visible to those who need to know.

Important points:

Notified bodies are required to report to their notifying authority on certificates issued, refused, suspended, or withdrawn, as well as any changes to their notification conditions and requests received from market surveillance authorities.
Notified bodies must also share information with each other, including negative conformity assessment outcomes and, on request, positive ones, particularly where they cover the same types of AI systems.
All information obtained in this process must be kept confidential in accordance with Article 78 of the regulation.

1. Notified bodies shall inform the notifying authority of the following:
  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 regarding conformity assessment activities;
  5. on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
1. Each notified body shall inform the other notified bodies of:
  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 quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued;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 Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.
1. 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.
1. Notified bodies shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.