CE Marking
RegulatoryWhat It Means
CE Marking is like a safety certification sticker that your AI products must have to legally sell them in Europe. It's your company's declaration that your AI systems comply with all EU regulations, including the new AI Act requirements for safety and risk management.
Why Chief AI Officers Care
Without CE Marking, you cannot legally market or sell AI products in the 27 EU countries plus Norway, Iceland, and Liechtenstein - that's nearly 450 million potential customers. As the responsible executive, you must ensure your AI systems undergo proper conformity assessments and maintain documentation proving compliance, or face market exclusion and potential fines.
Real-World Example
A US company developing an AI-powered medical diagnostic tool must obtain CE Marking before selling in Europe, which requires demonstrating their AI meets accuracy standards, has proper risk management processes, maintains audit trails, and includes human oversight capabilities as mandated by the AI Act.
Common Confusion
Many executives think CE Marking is just a one-time certification process, but it's actually an ongoing compliance responsibility where you self-declare conformity and must continuously maintain evidence that your AI systems meet all applicable EU standards.
Industry-Specific Applications
See how this term applies to healthcare, finance, manufacturing, government, tech, and insurance.
Healthcare: In healthcare, CE Marking for AI systems must demonstrate compliance with both the Medical Device Regulation (MDR) and t...
Finance: In finance, CE Marking becomes critical for AI-powered financial products like algorithmic trading systems, credit scori...
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Includes:
- 6 industry-specific applications
- Relevant regulations by sector
- Real compliance scenarios
- Implementation guidance
Technical Definitions
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