v2024-08-01
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.
Annotations · 3 entries
2021-04-21
Commission Proposal — COM(2021) 206 final
Article 48 — EU declaration of conformity
1. The provider shall draw up a written EU declaration of conformity for each AI system and keep it at the disposal of the national competent authorities for 10 years after the AI system has been placed on the market or put into service. The EU declaration of conformity shall identify the AI system for which it has been drawn up. A copy of the EU declaration of conformity shall be given to the relevant national competent authorities upon request. 2. The EU declaration of conformity shall state that the high-risk AI system in question meets the requirements set out in Chapter 2 of this Title . The EU declaration of conformity shall contain the information set out in Annex V and shall be translated into an official Union language or languages required by the Member State(s) in which the high-risk AI system is made available. 3. Where high-risk AI systems are subject to other Union harmonisation legislation which also requires an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all Union legislations applicable to the high-risk AI system. The declaration shall contain all the information required for identification of the Union harmonisation legislation to which the declaration relates. 4. By drawing up the EU declaration of conformity, the provider shall assume responsibility for compliance with the requirements set out in Chapter 2 of this Title . The provider shall keep the EU declaration of conformity up-to-date as appropriate. 5. The Commission shall be empowered to adopt delegated acts in accordance with Article 73 for the purpose of updating the content of the EU declaration of conformity set out in Annex V in order to introduce elements that become necessary in light of technical progress.
July 2024
Final Adopted Text — Regulation (EU) 2024/1689
Article 48 — CE marking
High-risk AI systems should bear the CE marking to indicate their conformity with this Regulation so that they can move freely within the internal market. For high-risk AI systems embedded in a product, a physical CE marking should be affixed, and may be complemented by a digital CE marking. For hig…
European Commission Guidelines Adopted 29 July 2025
Cites §2.1, p. 7, §6.2, p. 78
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- GuidanceEuropean Commission
- RecitalRecital 129
High-risk AI systems should bear the CE marking to indicate their conformity with this Regulation so that they can move freely within the internal market. For high-risk AI systems embedded in a product, a physical CE…
- HistoryCommission Proposal
1. The provider shall draw up a written EU declaration of conformity for each AI system and keep it at the disposal of the national competent authorities for 10 years after the AI system has been placed on the market or…
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