CE Marking (AI)
The conformity marking required for high-risk AI systems placed on the EU market, indicating that the system has undergone the required conformity assessment and meets all applicable EU AI Act requirements. The CE mark must be visible, legible, and affixed before the system is made available.
Why It Matters
No CE mark, no EU market access. For high-risk AI systems, CE marking is the visible proof of compliance — it's what regulators, customers, and deployers look for to confirm the system has been properly assessed.
Example
An AI-powered medical diagnostic tool receives its CE marking after the provider completes a third-party conformity assessment, demonstrates compliance with data governance and transparency requirements, and files an EU declaration of conformity.
Think of it like...
CE marking for AI is like the UL safety mark on electrical appliances — it tells buyers the product has been tested and meets the required safety standards for the market.
Related Terms
Conformity Assessment
The process by which a high-risk AI system is evaluated against regulatory requirements before being placed on the market. Under the EU AI Act, this may involve self-assessment by the provider or evaluation by an independent third-party body, depending on the system's use case.
EU Declaration of Conformity
A written declaration by the provider of a high-risk AI system stating that the system meets all applicable EU AI Act requirements. The declaration must be kept up to date, retained for at least 10 years after the system is placed on the market, and made available to national authorities on request.
EU AI Act
The European Union's comprehensive regulatory framework for artificial intelligence, establishing rules based on risk levels. It categorizes AI systems from minimal to unacceptable risk with corresponding compliance requirements.