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Article 48

CE marking

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.

Frequently Asked Questions

The CE marking indicates that a high-risk AI system meets safety, health, and environmental protection standards required by the AI Act and can be lawfully provided throughout the European Union. It confirms that the AI system has undergone proper assessments to ensure it is reliable, safe, and suitable for public use.
The CE marking must be clearly visible, readable, and permanent on the high-risk AI product itself. If such placement isn’t feasible, due to the system’s physical nature or design, then the marking should appear clearly either on the product’s packaging or in the official documentation that accompanies the AI system.
Yes, if the high-risk AI system is delivered digitally through the internet or an electronic platform, a digital CE marking can be used. This digital marking must be easy to locate and access directly through the software interface itself or via a clearly displayed electronic code or other simple and convenient digital method.
Yes, if a notified body performs the conformity assessment for a high-risk AI system, its specific identification number must follow the CE marking. This identification number must appear wherever the CE marking is placed, and the provider must also include it in any promotional materials mentioning the CE marking and compliance.

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