Under Article 48, the CE marking must be affixed visibly, legibly and indelibly to a high-risk AI system, or, where that is not possible or not warranted, to its packaging or accompanying documentation, after the EU declaration of conformity has been drawn up. For a system provided digitally, a digital CE marking must be used, accessible through the interface or via a machine-readable code or other electronic means. The marking indicates conformity with the AI Act and other applicable Union law, and must not be misleading.
When is CE marking affixed?
CE marking is affixed after the conformity assessment has been completed and the EU declaration of conformity has been drawn up. The sequence is a legal requirement, not a matter of convenience: affixing the marking before assessment, or before the declaration, misstates the position the marking is meant to convey. The provider should record the date of assessment, the date of the declaration, and the date the marking was affixed, so that the sequence can be verified. Where a system is updated and a new assessment is required, the marking position must be reassessed for the new version, and the provider should not continue to rely on a marking that was affixed for an earlier, different version. The marking file should be linked to the version history, so that each version's marking status is clear.
Where must the marking appear?
The marking must be affixed to the system itself where possible, in a visible, legible and indelible form. Where affixing to the system is not possible or not warranted on account of the nature of the system, the marking may be affixed to the packaging or to the accompanying documentation. For a high-risk system provided digitally, Article 48 provides for digital CE marking, which must be accessible through the interface or via a machine-readable code or other electronic means. The provider should record where the marking appears for each form in which the system is supplied, and should check that the marking remains visible and legible in the form the deployer and the user actually encounter. A marking that is present only in an internal file, or only on a web page that is not linked to the system, does not meet the article.
For the broader regulatory framework, see Conformity assessment and CE marking overview.
What does CE marking indicate?
CE marking indicates that the high-risk AI system conforms with the AI Act and with other applicable Union harmonisation legislation that provides for CE marking, as stated in the declaration of conformity. It is a declaration by the provider, under its sole responsibility, that the applicable conformity procedure has been followed and the requirements are met. It does not indicate that the system has been approved by a regulator, that every output will be correct, or that other laws, such as data protection or sectoral law, have been complied with beyond the scope of the declaration. Readers, including deployers and procurers, should read the marking together with the declaration, the instructions for use, and the registration entry, rather than treating the marking alone as a complete assurance.
What about the notified body number?
Where a notified body has been involved in the conformity assessment procedure, the CE marking must be followed by the identification number of the notified body, as Article 48 and the relevant procedure provide. The number must be that of the body that carried out the assessment for the system in question, and it must be affixed by the body itself or, where the Act provides, by the provider on the body's instructions. The provider should record which body, which number, and which assessment the number relates to, and should check that the number matches the certificate. A marking that carries a number for a different body, a different system, or an expired certificate misleads the reader and breaks the link between the marking and the assessment it is meant to evidence.
What marking must be avoided?
Member States must ensure that CE marking is not misused, and providers must not affix a marking, sign or inscription that is likely to mislead third parties as to the meaning or form of the CE marking, or that reduces its visibility or legibility. That includes using a similar mark for a different purpose, placing a competing mark in a way that obscures the CE marking, or using CE marking for a system that has not completed the required assessment. Marketing material should not present the marking as a safety guarantee or as a regulator's endorsement. The provider should review packaging, interfaces, documentation and marketing material together, to ensure that the marking appears correctly and that no other mark creates confusion about what the CE marking means for that system.
Continue with EU declaration of conformity under Article 47.
What does this guide not decide?
This guide does not decide whether CE marking has been correctly affixed to a particular system, whether a digital marking is accessible as the article requires, or whether a marking is misleading. It does not assess a declaration, a certificate, or a packaging design. Those questions depend on the system form, the assessment and declaration, the certificate where one exists, and the consolidated legal text. A provider should check the marking for each form of supply, record where it appears, and confirm the position with a competent authority, a notified body where involved, or a legal adviser where the position is contested.
Frequently asked questions
Can CE marking be affixed before conformity assessment?
No. CE marking follows the conformity assessment and the drawing up of the EU declaration of conformity. Affixing it before those steps misstates the position and should not be done, even where the provider expects the assessment to succeed.
How does digital CE marking work?
For a system provided digitally, a digital CE marking must be used, accessible through the interface or via a machine-readable code or other electronic means. The provider should record how the marking is accessed, test that it is reachable from the system as supplied, and keep it linked to the declaration and registration.
Does CE marking mean a regulator approved the system?
No. CE marking is the provider's declaration, under its sole responsibility, that the applicable conformity procedure was followed and the requirements are met. It should be read with the declaration, instructions and registration, and it does not by itself prove compliance with every other law that may apply.
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This article is an informational overview, not a legal determination. Check the current legal text and official implementation guidance for your system and role.
Consolidated Regulation (EU) 2024/1689 ↗Commission AI Act Service Desk timeline ↗European Commission AI Act overview ↗