A lot of sellers put the CE mark on their product and think the job is done. It is not. The mark is only as valid as the documentation behind it. That documentation is called a Technical File, and if you cannot produce it when asked, your product is non-compliant by default.

What goes inside a Technical File

1. Product description - What it is, what it does, what it is made of
2. Design and manufacturing info - Drawings, components, materials, production process
3. Risk assessment - Every potential hazard identified, evaluated, and addressed
4. List of standards applied - Which EU harmonised standards your product was tested against
5. Test reports - Actual results from lab testing or internal verification
6. Declaration of Conformity - The signed document that ties everything together
7. Labelling and instructions - What appears on the product, packaging, and manual

Do you submit it anywhere?

No. You keep it.

But if a market surveillance authority ever comes knocking, you do not want to be a deer in headlights. They give tight deadlines, usually just a few days to hand it over. Be prepared before that knock happens.

Fail to produce it and your product is considered non-compliant. Regardless of how safe it actually is.

The distinction that matters

The Technical File is not proof that your product is safe. It is proof that you can demonstrate it is safe.

There is a difference.

Need help putting one together?

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