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Chapter III, Section 5 — Standards, conformity assessment, certificates, registrationArticle 48

Article 48: CE Marking for High-Risk AI Systems

Applies from 2 Aug 20264 min readEUR-Lex verified Apr 2026

Article 48 requires the CE marking to be affixed to high-risk AI systems to indicate conformity with the Regulation. The marking must be affixed visibly, legibly, and indelibly to the AI system or, where not possible, to its packaging or accompanying documentation. The CE marking is subject to the general principles in Regulation (EC) No 765/2008 (the NLF accreditation and market surveillance regulation). For AI systems that are purely digital (no physical product), the CE marking appears in the digital documentation or user interface.

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Who does this apply to?

  • -Providers of high-risk AI systems who must affix CE marking after conformity assessment
  • -Importers and distributors who must verify CE marking before making systems available
  • -Market surveillance authorities inspecting CE-marked AI systems

Scenarios

A provider of a SaaS-based high-risk HR screening tool includes the CE marking in the system's digital interface and accompanying documentation.

Correct for digital-only AI: CE marking in the UI/documentation satisfies Article 48 when no physical product exists.
Ref. Art. 48

A medical device with embedded AI bears a CE marking under both MDR and AI Act requirements.

One CE marking covers both regimes — the marking indicates conformity with all applicable Union harmonisation legislation.
Ref. Art. 48 + Annex I

CE marking rules (plain terms)

Article 48 establishes:

1. The CE marking indicates conformity with Chapter III requirements 2. It must be affixed before the system is placed on the market 3. It must be visible, legible, and indelible 4. For physical products: on the product itself, or packaging/documentation if not feasible 5. For digital-only systems: in the digital documentation, user interface, or equivalent 6. The CE marking is subject to Regulation (EC) No 765/2008 general principles 7. Where a notified body was involved (Annex VII), its identification number appears next to the CE marking

The CE marking must not be affixed unless a valid EU declaration of conformity has been issued.

How Article 48 connects to the rest of the Act

  • Article 16(h) — CE marking is a lettered provider obligation.
  • Article 43 — Conformity assessment must be completed before CE marking.
  • Article 47 — Declaration of conformity must be issued before CE marking.
  • Annex VI / Annex VII — Assessment routes that lead to CE marking.
  • Article 23 — Importers must verify CE marking.
  • Article 24 — Distributors must verify CE marking.

Compliance checklist

  • Complete conformity assessment (Article 43) and issue EU declaration (Article 47) before affixing CE marking.
  • Determine placement: physical product surface, packaging, documentation, or digital interface.
  • Ensure visibility, legibility, and indelibility of the marking.
  • For Annex VII systems: include the notified body identification number next to the CE marking.
  • For dual-regulated products: one CE marking covers both AI Act and sectoral law.
  • Do not affix CE marking without a valid, up-to-date declaration of conformity.
Read the official text on EUR-Lex

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Frequently asked questions

Where does CE marking go on a cloud-based AI?

For digital-only systems, the CE marking appears in the accompanying documentation, user interface, or digital product page — not on physical hardware.

Does CE marking mean the system is 'approved' by the EU?

No. CE marking is the provider's declaration of conformity, not government approval. It indicates self-assessed or third-party-verified compliance.

Does a high-risk AI system embedded in a product need separate CE marking?

Where a high-risk AI system is a safety component of a product covered by Annex I legislation, the CE marking for the overall product covers the AI Act requirements as well. Article 48(3) clarifies that the single CE marking indicates conformity with all applicable Union harmonisation legislation. No separate AI-specific CE mark is required.