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Article 46

Information Obligations of Notified Bodies

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

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

  1. any Union technical documentation assessment certificates, any supplements to those certificates, 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 subcontract

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 quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued;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 EU technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.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

3a. The obligations referred to in paragraphs 1 to 3 shall be complied with in accordance with Article 70.

[Previous version]

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

  1. any Union technical documentation assessment certificates, any supplements to those certificates, quality management system approvals issued in accordance with the requirements of Annex VII;
  1. 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;
  1. any circumstances affecting the scope of or conditions for notification;
  1. any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
  1. 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;
  1. EU 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 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 to 3 shall be complied with in accordance with Article 70.

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