Chapter III · Section 5 · Standards, conformity assessment, certificates, registration
Article 48 — CE marking
▼ Primary text, verbatim. Our annotations appear below, visibly separated.
1. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
2. 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.
3. 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.
4. 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.
5. 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.
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex.
What this means for you
In your terms · EU declaration of conformity and CE marking
Digital systems carry a digital CE marking; it is part of the shipping surface.
In your terms · EU declaration of conformity and CE marking
The declaration is the formal claim that everything upstream (risk management, data, documentation, assessment) holds; signing it is the accountability moment.
- EU declaration of conformity per system
Failure smells likeThe system is on the market with no signed declaration behind it, because drawing one up was treated as paperwork that follows the release.
Obligations derived from this article
If you would rather not read the law
The basics page explains the Regulation's own categories in order: scope, role, tier, date. The engineering view groups the obligations by the platform capability they demand.