CHAPTER III

Article 48: CE marking

Plain English Summary

What this article does: Sets rules for affixing the CE marking to high-risk AI systems. Who it applies to: Providers of high-risk AI systems. Key requirements: Para 1: The CE marking must be affixed visibly, legibly, and indelibly to the high-risk AI system. Where not possible due to the system's nature, it must be affixed to the packaging or documentation. Para 2: The CE marking is subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008. Para 3: Where applicable, the CE marking must be followed by the identification number of the notified body responsible for conformity assessment. Para 4: Member States must ensure the CE marking regime is properly implemented and take appropriate action in the event of improper use.

1. The CE marking shall be subject to the general principles set out in 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.

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