Meet Notified-Body Information-Sharing and Reporting Obligations

Sub-obligations

These are independently assessable parts of the parent requirement.

1. Article 45(1)

   Current

   Report Required Certificate, Approval and Notification Information to the Notifying Authority

   Tracker Networks Guidance

   Inform the notifying authority of issued, refused, restricted, suspended or withdrawn certificates/approvals, changes affecting notification conditions, market-surveillance information requests and, on request, conformity-assessment activities including cross-border work and subcontracting.

   Official text

   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.

   Suggested controls

   • Regulatory Information and Cooperation Process

     Respond to reasoned regulator requests with controlled, complete and retrievable compliance information and logs.

   • Notified-Body Regulatory Reporting and Continuity

     Report required information to notifying authorities and peer notified bodies and manage continuity when designation changes or activities cease.

   Related risks

   • Regulatory Cooperation Failure

     The organisation may be unable to provide complete, timely and understandable information, records or cooperation to competent authorities.

   • Notified-Body Subcontracting, Certificate or Reporting Failure

     Subcontracted assessment work, certificate management or required regulatory reporting may not meet AI Act requirements.

2. Article 45(2)-(4)

   Current

   Share Required Conformity-Assessment Information With Peer Notified Bodies

   Tracker Networks Guidance

   Share specified negative and, where requested, positive conformity-assessment results with other notified bodies performing similar activities and safeguard the confidentiality of information obtained.

   Official text

   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.

   Suggested controls

   • Notified-Body Independence, Confidentiality and Competence

     Maintain notified-body independence, impartiality, confidentiality, cybersecurity, insurance and qualified personnel.

   • Notified-Body Regulatory Reporting and Continuity

     Report required information to notifying authorities and peer notified bodies and manage continuity when designation changes or activities cease.

   Related risks

   • Notified-Body Independence, Confidentiality or Competence Failure

     A notified body may suffer conflicts of interest, information leakage, insufficient expertise or weak governance that undermines assessment integrity.

   • Notified-Body Subcontracting, Certificate or Reporting Failure

     Subcontracted assessment work, certificate management or required regulatory reporting may not meet AI Act requirements.