Declarations of conformity and technical files

• Regulation (EU) 2019/1020 — market surveillance
• Decision No 768/2008/EC — common framework
• Sectoral legislation for each product category

Who has to appoint one

Any manufacturer outside the Union whose products carry CE marking. The documentation is the first thing an authority asks for, and the authorised representative must be able to produce it, which requires actual access rather than a promise from the factory.

Thresholds and exemptions

None. Every CE-marked product has a declaration of conformity and a technical file, whatever the category.

What must appear on the label

The declaration of conformity is a document, not a label, but the product must carry the CE marking, the manufacturer's identity and the representative's or importer's EU address so that the documentation can be traced.

Marketplace fields

Marketplaces request the declaration when a listing is challenged, and the most common failure is producing a supplier document naming the factory rather than a declaration in the brand owner's name.

Documentation you must hold

A single declaration covering every applicable act, identifying the product unambiguously, naming the legislation and the standards applied, the notified body and certificate where relevant, and signed on behalf of the manufacturer with the name and function of the signatory. The technical file holds the design documentation, the risk assessment, the test reports and the production control description.

Standards and testing

Not applicable directly, but the file must contain the evidence: a declaration without underlying test reports is a statement without a basis, and that is how enforcement cases are lost.

Language requirements

The declaration must be translated into the language required by the member state where the product is placed on the market, and supplied with the product where the sectoral act requires it.

When it applies

Both must exist before the first unit is placed on the market. Reconstructing a file after an authority request is not compliance and is usually obvious.

How long records are kept

Ten years from the date the last unit was placed on the market, longer for some sectors.

What happens if you do not comply

Absence of documentation is itself an infringement leading to withdrawal, regardless of whether the product is actually unsafe. It is the most common finding in market surveillance because it is the easiest to establish.

Who enforces it

Market surveillance authorities, customs and notified bodies.

Where the boundary lies

A representative that holds only a scanned declaration cannot answer an authority asking for the risk assessment or the test reports. The mandate must give access to the full file, and a factory unwilling to provide it is a commercial warning sign about the product itself.

Questions we are asked

Can we use our supplier's declaration?

Only if the supplier is the manufacturer and the product is sold under its name. Selling under your own brand makes you the manufacturer, and the declaration must be in your name.

How long do we keep the file?

Ten years from the last unit placed on the market for most sectors, and fifteen for some medical devices.