Chapter III · High-risk AI systems
Article 48 — CE marking
Official text
Each paragraph records where its wording comes from. This site reproduces the text; the authentic publication is the Official Journal. Text checked as byte-identical to the Official Journal is marked as reproduced from it; consolidated text is editorial and has no legal value. Paragraphs, subparagraphs and points each have their own link.
The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
Reproduced from the Official Journal · Regulation (EU) 2024/1689 · EN
For high-risk AI systems provided digitally, a digital CE marking shall be used, only if it can easily be accessed via the interface from which that system is accessed or via an easily accessible machine-readable code or other electronic means.
Reproduced from the Official Journal · Regulation (EU) 2024/1689 · EN
The CE marking shall be affixed visibly, legibly and indelibly for high-risk AI systems. Where that is not possible or not warranted on account of the nature of the high-risk AI system, it shall be affixed to the packaging or to the accompanying documentation, as appropriate.
Reproduced from the Official Journal · Regulation (EU) 2024/1689 · EN
Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 43. The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the provider or by the provider’s authorised representative. The identification number shall also be indicated in any promotional material which mentions that the high-risk AI system fulfils the requirements for CE marking.
Reproduced from the Official Journal · Regulation (EU) 2024/1689 · EN
Where high-risk AI systems are subject to other Union law which also provides for the affixing of the CE marking, the CE marking shall indicate that the high-risk AI system also fulfil the requirements of that other law.
Reproduced from the Official Journal · Regulation (EU) 2024/1689 · EN
The formal analysis of Article 48
Article 6 is formalised first. The remaining articles follow.
Article 48 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