Guide

CE marking: when self-declaration is enough

Self-declaration is common, but it is not a shortcut. What the technical file must contain and when a notified body is required.

Updated 2026-10-22

What self-declaration means

For many products, the manufacturer can carry out the conformity assessment and issue the EU declaration of conformity without a notified body. The CE mark is then applied on the manufacturer's own responsibility.

Self-declaration is not a lighter version of compliance. It means you hold the evidence and accept the liability.

What the technical file needs

A technical file typically includes product description and drawings, the list of applicable directives, test reports, risk assessment, instructions, and the declaration of conformity.

The file must be sufficient for an authority to understand what was assessed and why the product meets the requirements.

When a notified body is required

Some product categories and some directives require third-party involvement, for example certain radio equipment, medical devices, and higher-risk machinery.

If a notified body is required, self-declaring around it does not make the product compliant.

Common failures

The most common failures are an incomplete declaration, a technical file that references the wrong directive, and a CE mark applied to a product that was never assessed against the applicable standards.

Another frequent issue is an importer or authorised representative missing from the product or packaging, which is a separate obligation from CE marking itself.

FAQ

Related requirements