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Article 45

Information Obligations of Notified Bodies

Updated on May 8th 2024 based on the version and article numbering in the EU Parliament's 'Corrigendum' version dated April 19th 2024.

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.

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 quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued;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 Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.

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.

[Previous version]

Updated on April 10th 2024 based on the version and article numbering approved by the EU Parliament on March 13th 2024.

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.

2. 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.

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. The obligations referred to in paragraphs 1, 2 and 3 of this Article shall be complied with in accordance with Article 78.

Removed on Feb 6th 2024 based on the version endorsed by the Coreper I on Feb 2nd

Appeal Against Decisions of Notified Bodies

An appeal procedure against decisions of the notified bodies shall be available.

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