CE Marking

Affixing the CE mark requires a signed Declaration of Conformity, a legally binding document asserting compliance with all relevant regulations. This document must be translated into the languages required by the member states where the product is sold and kept for 10 years after the last unit is placed on the market. It is the physical manifestation of the provider assuming full legal liability.

The CE marking operates on the principle of mutual recognition. Once a high-risk AI system is correctly marked based on a conformity assessment in one EU member state, it can be freely traded across all 27 member states plus Iceland, Liechtenstein, and Norway without additional national modifications. This eliminates the need for 30 separate national certifications.

The mark must be affixed visibly, legibly, and indelibly to the AI system or its data plate. For purely digital software, it must be displayed in a digital format accessible via the user interface. The mark must follow strict proportional geometry: if enlarged or reduced, the proportions of the logo must be respected, with a minimum height of 5 mm.

The CE marking must be accompanied by the Unique Registration ID assigned by the EU database. This alphanumeric code creates a direct digital thread connecting the physical product to its technical documentation, conformity assessment certificate, and post-market monitoring history, enabling instant verification by market surveillance authorities.

The CE mark cannot be affixed until all prior regulatory gates are cleared. This includes completion of the conformity assessment, successful audit of the Quality Management System, and registration in the EU database. Placing a mark on a non-compliant product constitutes a criminal offense in most member states, triggering immediate market withdrawal.

For non-EU providers, the importer acts as the compliance gate. Before placing an AI system on the market, the importer must physically verify that the CE mark is correctly affixed, the Declaration of Conformity exists, and the manufacturer has designated an Authorized Representative within the Union. The importer's name and address must also appear on the product.