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Article 48

UpcomingConditional timing

Affix the Required CE Marking to High-Risk AI Systems

Applies to Provider; High-Risk AI.

Actors
Provider
AI class
High-Risk AI
Context
EU Market Access
Themes
Risk & AssuranceGovernance & Accountability

Tracker Guidance

Affix the CE marking in the form appropriate to the system. Digital systems should use an easily accessible digital CE marking. Where required, include the notified body's identification number and ensure the marking is visible, legible and indelible or appropriately placed on packaging/documentation.

Official text

Article 48Official source
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.

Timing depends on the system

  • 2 Dec 2027Article 6(2) / Annex III high-risk AI
  • 2 Aug 2028Article 6(1) / Annex I Section A high-risk AI
  • 2 Dec 2027Pre-existing Annex III high-risk AI type/model first placed on the market or put into service before 2027-12-02
  • 2 Aug 2028Pre-existing Article 6(1) / Annex I high-risk AI type/model first placed on the market or put into service before 2028-08-02
  • 2 Aug 2030Pre-existing high-risk AI intended to be used by public authorities

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Article 48: Affix the Required CE Marking to High-Risk AI Systems | EU AI Act Library