Generating a CE certification for your AI product according to European Union (EU) standards
Published by Tobias Goecke, SupraTix GmbH (3 weeks, 1 day ago updated)
To obtain CE certification for an AI product in the EU, identify relevant directives and assess conformity procedures. Test the product to meet health, safety, and environmental standards. Compile technical documentation detailing product compliance, including test results and risk analysis. Draft and sign the EU Declaration of Conformity, declaring product compliance with EU regulations. Affix the CE mark visibly on the product. Maintain documentation for 10 years. Consider consulting SupraTix experts due to the complexity and evolving EU regulations on AI.
Generating a CE certification for an AI product involves several steps, ensuring that the product meets the European Union (EU) standards for health, safety, and environmental protection. CE marking is mandatory for products within its scope before they can be sold in the EU. Here is a simplified overview of the process:
- Identify the EU Directives and Regulations that apply to your product: Different products have different requirements. For AI products, relevant directives could include the Radio Equipment Directive, the Electromagnetic Compatibility Directive, or potentially the Machinery Directive, among others.
- Determine the conformity assessment procedure for your product: Depending on the directives applicable to your product, you might need to conduct internal production control, involve a Notified Body, or undertake specific conformity assessment procedures.
- Test the product and check its conformity: Testing should be done according to the standards laid out in the relevant directives. This often involves ensuring the safety, health, and environmental protection standards are met. For AI products, it might also involve ensuring compliance with data protection regulations like the GDPR if personal data processing is involved.
- Compile the Technical Documentation: The technical documentation provides information that proves your product complies with the relevant EU requirements. This includes design, manufacture, and operation details, including results from conformity assessment tests and an analysis of risks and how they are mitigated.
- Draft and sign the EU Declaration of Conformity (DoC): The DoC is a document in which the manufacturer declares that their product meets all relevant EU requirements. Signing it implies you take full responsibility for your product's conformity.
- Affix the CE Marking to your product: Once steps 1-5 are completed, and you've ensured compliance with all applicable requirements, you can then affix the CE mark to your product. The CE mark must be visible, legible, and indelible.
- Keep all documentation for 10 years: EU regulations typically require you to keep the technical documentation and the DoC for 10 years after the product has been placed on the market.
It's also important to stay informed about the EU's AI Act, which, at my last update, was a significant regulatory development affecting AI products in the EU. Depending on its final form and implementation timeline, it could introduce additional requirements for AI systems.
Given the complexity of the process and the specific technical and legal nuances involved, it's often advisable to consult with SupraTix experts in EU law and product certification. They can provide guidance tailored to your product, especially for innovative AI applications where the regulatory landscape is rapidly evolving.
