CE Marking for AI Systems Template
Procedural checklist for affixing the CE marking to high-risk AI systems, covering all pre-conditions, documentation requirements, and marking obligations.
Quick Answer
CE marking for high-risk AI systems requires completed conformity assessment, an EU Declaration of Conformity, EU database registration, and visible affixing of the mark — before any placement on the EU market.
Compliance Checklist (8 items)
Penalty if not compliant
Up to €30 million or 6% of global annual turnover; national authorities can prohibit or restrict market access for non-marked products.
Frequently Asked Questions
Can a high-risk AI system be sold in the EU without a CE mark?
No. CE marking is a mandatory pre-condition for placing high-risk AI systems on the EU market. Systems without it can be prohibited from sale and may be subject to recall.
What if my AI system is already CE-marked under another directive (e.g., MDR)?
You must also satisfy EU AI Act conformity assessment requirements separately. The CE mark covers both, but each regulatory framework's documentation and assessment obligations must be met independently.
Is CE marking required for AI systems used internally (not sold externally)?
CE marking is required when the system is placed on the market or put into service in the EU. Organisations using high-risk AI internally (as deployers) are subject to deployer obligations, not provider CE marking obligations — unless they substantially modify the system.
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