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AI Compliance

CE marking (AI) 

The CE Marking for AI is the mandatory legal symbol that must be affixed to a high-risk AI system to attest that it has undergone the required conformity assessment and fully complies with all applicable EU legislation, including the stringent requirements of the EU AI Act.

Far more than a label, the CE marking is a declaration by the provider that the AI system is legally fit for the EU market. It signifies that the system has been systematically evaluated for risks to health, safety, and fundamental rights. For AI, this marking specifically signals conformity with the new, AI-specific regime, in addition to other relevant directives (e.g., for machinery or medical devices). It is the final, visible output of the conformity assessment process and is the provider's assumption of legal liability for the product's compliance.

Affixing the CE marking involves a strict, documented protocol:

Declaration of Conformity: The provider must draft and sign a formal, legally binding document stating the AI system meets all requirements, listing the harmonized standards applied, and identifying the Notified Body if one was involved.

Technical File Compilation: Maintaining the complete technical documentation that substantiates the declaration, which must be made available to national authorities upon request for a period of ten years after the system is placed on the market.

Marking Application: Physically affixing the CE marking to the product, its packaging, or accompanying documentation in a visible, legible, and indelible manner, accompanied by the identification number of the involved Notified Body, if applicable.

Regulatory Context: Governed by Article 49 of the EU AI Act, the CE marking for AI systems integrates into the broader EU product compliance framework. It is illegal to place a high-risk AI system on the EU market without this marking once the Act's provisions become applicable.

Market and Liability Implications: The CE marking grants the system the "right of free movement" within the EU's internal market. However, it also represents the point at which the provider assumes full legal responsibility. An incorrect or fraudulent marking is a severe violation that can lead to immediate market withdrawal, substantial fines, and liability for damages caused by the non-compliant system.

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