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CE technical file: what it must contain

The technical documentation (technical file) is the evidence that the product meets the essential requirements. It is not submitted anywhere in advance, but authorities can ask for it at any time, and the manufacturer must be able to provide it.

Kept for 10 years Available on request Risk assessment required Any EU language authorities understand

Contents checklist

Based on the internal production control module (Module A) in Decision No 768/2008/EC, which most CE marking acts adopt. Sector legislation may add items.

Who keeps it and for how long

OperatorObligation
ManufacturerDraws up the file and keeps it for 10 years after the product has been placed on the market (unless the legislation sets another period).
Authorised representativeKeeps the DoC and technical file at the disposal of authorities, if this is part of its written mandate.
ImporterEnsures the technical file can be made available to authorities on request and keeps a copy of the DoC for 10 years.

The file must be supplied on a reasoned request from a market surveillance authority, in a language that authority can easily understand. In practice, keep it in English and translate on request.

Why technical files fail

1

Tests on a different model

Test reports must cover the product as sold, including all variants and power supplies.

2

No risk assessment

Test reports alone do not replace the manufacturer's own risk analysis.

3

Outdated standards

Standards that are no longer harmonised no longer give a presumption of conformity.

4

No access

A non-EU manufacturer that does not answer leaves its EU importer or representative liable.

Frequently asked questions

Do I need to send my technical file to anyone before selling?

No, for most products. The file is kept by the manufacturer and provided on request. Where a Notified Body is involved, it reviews the parts relevant to its assessment.

Can test reports from a Chinese laboratory go into the technical file?

Yes, if they cover the product as sold and test against the right standards. Authorities may question reports that are incomplete, outdated or for a different model.

How long must the technical file be kept?

Generally 10 years after the product has been placed on the market. Some legislation sets a different period.

Related guides

Note: This guide provides general information about EU product legislation, not legal advice. Check the current legal texts on EUR-Lex for your product. Last reviewed 5 October 2026.

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