Article 45: Information Obligations of Notified Bodies | EU AI Act

Article 45 of the AI Act provides critical guidance related to the information obligations of all notified bodies. Notified bodies are organizations that assess a product's conformity before it is available for sale in the EU.

The notified bodies must inform the notifying authority of the following:

• Any Union technical documentation assessment certificates, supplements to such certificates, as well as quality management system approvals issued in accordance with Annex VII;
• Any refusals, restrictions, suspensions, or withdrawals of Union technical documentation assessment certificates, or a quality management system approvals issued in accordance with Annex VII;
• Any circumstances that affect the scope or conditions for notifications;
• Any requests for information received from market surveillance authorities related to conformity assessment activities;
• All information related to conformity assessment activities performed within the scope of the notification and other activities performed, such as cross-border activities and subcontracting, when requested.

Similarly, each notified body must inform the other notified bodies of the following:

• Any quality management system approvals that it refused, suspended, or withdrew and, upon request, information related to quality management system approvals it issued;
• Union technical documentation assessment certificates or supplements to such certificates that it has refused, withdrawn, suspended, or restricted. Additionally, upon request, it shall provide details of any certificates and supplements that it issued.

Each notified body must provide all other notified bodies performing similar conformity assessment activities covering the same types of AI systems with the necessary information related to the negative and, on request, positive results of conformity assessment.

Notified bodies must maintain the confidentiality of the information they receive in accordance with Article 78.