Art. 48 CE marking | AI act regulation | AI act

This article sets out the practical rules for how the CE marking must be applied to high-risk AI systems.

It connects directly to Article 47, which requires providers to draw up an EU declaration of conformity, and to Article 43, which governs the conformity assessment procedures.

Here, the focus shifts to the physical or digital display of the CE marking itself — where it goes, how it looks, and what additional information must accompany it.

The article also addresses situations where a high-risk AI system falls under other Union law that independently requires CE marking, ensuring the single marking covers all applicable requirements.

Important points:

Affix the CE marking visibly, legibly and indelibly to the high-risk AI system, its packaging, or accompanying documentation; for digitally provided systems, it must be easily accessible via the interface or a machine-readable code.
Where a notified body was involved in the conformity assessment, its identification number must accompany the CE marking on the system and in any promotional material referencing CE compliance.
Where other Union law also requires a CE marking on the same high-risk AI system, the single CE marking must indicate conformity with all of that other law as well.

1. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
1. 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.
1. 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.
1. 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.
1. 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.

Article 48 CE marking

Relevant recitals