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CE marking (AI)

Definition

The marking by which a provider indicates that a high-risk AI system conforms to the EU AI Act and other applicable EU harmonization legislation.

CE marking is a long-standing feature of the EU single market, governed in general by Regulation (EC) No 765/2008. The EU AI Act extends it to high-risk AI systems. After completing the conformity assessment and drawing up the EU declaration of conformity (Article 47), the provider affixes the CE marking visibly, legibly and indelibly (Article 48). For systems delivered digitally, a digital CE marking is used, easily accessible through the interface or a machine-readable code. Where a notified body took part in the assessment, its identification number follows the marking.

The marking is a declaration by the provider, not a quality label or an approval granted by the EU. It tells market surveillance authorities and buyers that the provider takes responsibility for conformity. For deployers, checking for CE marking, the declaration of conformity and registration in the EU database is part of due diligence before procuring a high-risk system. A missing or improperly affixed marking can lead authorities to restrict or withdraw the system from the market.

Where this term is assessed

Assessed in the Responsible AI Auditor (AUDAI), domain 4: Regulatory conformity.

Also covered in: Responsible AI Practitioner (RAIP)

Primary sources

  • Regulation (EU) 2024/1689 (AI Act), Arts. 47-48
  • Regulation (EC) No 765/2008

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