CE marking
The CE marking is the high-risk AI system provider's declaration that the system complies with the Regulation's requirements. It must be affixed, after the conformity assessment procedure is completed, visibly, legibly and indelibly to the system or its packaging, or — where this is not possible — to the accompanying documentation.
The rules on marking are set out in Article 48. Within the AI Act framework, the CE marking plays the same role as in other Union product-safety legislation: a declaration, made on the provider's own responsibility, of conformity, which the market surveillance authority may verify after the fact. Where the system is also subject to other Union legislation that likewise requires CE marking, a single marking indicates conformity with both sets of rules. Where a notified body has been involved, its identification number must also be affixed alongside the marking. Affixing the marking without authorisation — i.e. where a system bears the CE marking without the conformity assessment having actually taken place — can itself trigger a market surveillance measure and a penalty.
The CE marking may only be affixed once the conformity assessment has genuinely been completed — an SME becoming a provider should never treat this as a formality, since unauthorised affixing is itself a separate infringement.
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Start freeRelated terms
- Conformity assessmentConformity assessment is the procedure by which a provider demonstrates that a high-risk AI system meets the requirements laid down in Section 2 of Chapter III of the Regulation — risk management, data governance, documentation, human oversight, and the rest. For systems falling under points 2–8 of Annex III, internal control suffices; involvement of a notified body is typically mandatory only for biometric systems.
- EU declaration of conformityThe EU declaration of conformity is the provider's written statement that a high-risk AI system meets the applicable requirements of the Regulation. It must be drawn up per system, made available to the market surveillance authority, and kept for at least ten years after the system is withdrawn from the market.
- ProviderA provider is a natural or legal person that develops an AI system or a general-purpose AI model, or has one developed, and places it on the market or puts it into service under its own name or trademark, whether for payment or free of charge. Providers bear the Regulation's most extensive package of obligations: risk management, data governance, documentation, conformity assessment, CE marking.
Related questions in the knowledge base (Hungarian)
- Mi a szolgáltató kötelezettségeinek teljes listája magas kockázatú AI-rendszernél?A 16. cikk tizenkét pontban sorolja fel őket, két rétegben. A termék-réteg a 8–15. cikk: kockázatkezelés, adatkormányzás, műszaki dokumentáció, naplózás, átláthatóság, emberi felügyelet, pontosság és kiberbiztonság. A szervezeti réteg a 17–21., 43. és 47–49. cikk: minőségirányítás, dokumentumőrzés tíz évig, megfelelőségértékelés, EU-megfelelőségi nyilatkozat, CE-jelölés és regisztráció.
- Mit örököl a cég, ha az AI Act szerint szolgáltatóvá válik?A teljes 16. cikkes kötelezettségcsomagot, nem részlegesen: kockázatkezelés, adatkormányzás, műszaki dokumentáció, naplózás, alkalmazói tájékoztatás, emberi felügyelet tervezése, pontosság és kiberbiztonság, minőségirányítási rendszer, megfelelőségértékelés, EU-megfelelőségi nyilatkozat, CE-jelölés, regisztráció, forgalomba hozatal utáni nyomon követés és incidensbejelentés. Az eredeti szolgáltató ilyenkor megszűnik az adott rendszer szolgáltatója lenni.