Chapter III · High-risk AI systems
Article 45 — Information obligations of notified bodies
Official text
Each paragraph records where its wording comes from. Only text reproduced unchanged from the Official Journal is authentic; consolidated text is editorial and has no legal value. Paragraphs, subparagraphs and points each have their own link.
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.
Authentic — as published in the Official Journal
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quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued;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Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.
Authentic — as published in the Official Journal
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.
Authentic — as published in the Official Journal
Notified bodies shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.
Authentic — as published in the Official Journal
The formal analysis of Article 45
Article 6 is formalised first. The remaining articles follow.
Article 45 is formalised node by node: each rule as a deontic position with its operator, each exception with its rank, each predicate resolved against the definitions in Article 3.
What members get, per article
- the rule logic: every norm as a formal position, with the defeater chain that decides which exception wins
- the competency questions and their answers, every unanswered one marked as a gap and named
- the ontology: predicates bound to AISV (AI Standardisation Vocabulary) and to the definitions they depend on, exportable as JSON-LD and OWL
- the documentation: the Article 6(4) assessment record generated from a fact set, with its derivation and the version of the law it was decided against
Built for providers claiming the 6(3) derogation, for the counsel who has to defend that claim, and for the auditor who reads it afterwards.
Access is invite-only and opening in stages. Article 6 is formalised first; the remaining articles follow.
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Commentary in preparation
The official text above is complete. The editorial layer for this article — duties, the roles bound by them, the AISV concepts that model them, and the European standards written to support them — is in preparation, in the same form as the articles already published.
See the published articles