Article 45

Information obligations of notified bodies

1.   Notified bodies shall inform the notifying authority of the following:

(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;

(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;

(c)

any circumstances affecting the scope of or conditions for notification;

(d)

any request for information which they have received from market surveillance authorities regarding conformity assessment activities;

(e)

on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.

2.   Each notified body shall inform the other notified bodies of:

(a)

quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued;

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Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.

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.

4.   Notified bodies shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.

Frequently Asked Questions

Notified bodies must report various important details such as issued certificates, any refusals, suspensions or withdrawals of certificates, changes that could impact their notification scope, requests received from authorities about conformity assessments, and, upon request, details about their assessment activities, including cross-border or subcontracting activities.
Yes, notified bodies are required to inform other notified bodies about quality management approvals and technical documentation assessments they refuse, suspend, withdraw or restrict, and share issued approvals upon request, to promote transparency and collaboration in their conformity assessment processes for AI systems.
Yes, notified bodies must protect the confidentiality of all information they receive or exchange during their work, ensuring that sensitive technical or assessment-related details remain confidential according to rules described in Article 78, and that these are not improperly shared or misused.
If notified bodies encounter any changes affecting the conditions or scope under which they operate, they must promptly inform their notifying authority of these circumstances, allowing regulatory bodies to evaluate whether these changes affect the notified body’s ability to conduct assessments properly and reliably.

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