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EU AI Act glossary · Documents & conformity· Art. 48

CE marking

Article 48 requires the CE marking to be affixed to a high-risk AI system (or its documentation) to signal that it conforms to the EU AI Act. It is the visible sign that conformity assessment and the declaration of conformity are complete.

The CE marking must be affixed visibly, legibly and indelibly to the high-risk AI system, or where that is not possible to its packaging or accompanying documentation. For AI systems provided digitally, a digital CE marking may be used provided it is easily accessible via the interface or a readily accessible machine-readable code. Where a notified body was involved in the conformity assessment, its identification number follows the marking. It may only be affixed once the assessment has been passed and the declaration of conformity drawn up.

Where CE marking sits in the Regulation
  • Art. 48
  • Art. 47
  • Art. 49
Who it binds

CE marking: why it matters

The CE marking is the signal the rest of the supply chain relies on: importers and distributors verify it before they will handle a system, so its absence blocks the route to market regardless of how good the underlying engineering is. It is also a strict-order requirement — affixing it before the assessment is complete is itself an infringement, and because it is the most visible artefact in the regime it is the easiest thing for a competitor or authority to spot.

Worked example

CE marking in practice

A SaaS provider of a high-risk hiring tool has no physical product to sticker. It uses a digital CE marking surfaced in the product interface and in the downloadable documentation package, alongside the declaration of conformity, so that an EU customer's procurement team can verify conformity without contacting sales. That accessibility requirement is the substance of the obligation for software — the mark has to be findable, not merely issued.

Correction

CE marking: the mistake people make

Affixing or advertising a CE marking before the conformity assessment and declaration are complete, or assuming software is exempt because there is nothing physical to mark. Digital-only systems carry the duty through a digital marking accessible via the interface or a machine-readable code.

Questions

CE marking: common questions

Do software-only AI systems need a CE marking?
Yes. For digitally provided AI systems a digital CE marking is used, and it must be easily accessible through the interface from which the system is accessed or through an easily accessible machine-readable code.
When can the CE marking be affixed?
Only after the conformity assessment has been carried out and the EU declaration of conformity drawn up. Affixing it earlier is an infringement in itself.
What does the number next to the CE marking mean?
Where a notified body was involved in the conformity assessment, its four-digit identification number is affixed next to the CE marking, either by the body itself or on its instructions.
Keep reading

CE marking: terms that come up alongside it

See how CE marking applies to your systems

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