Product technical documentation: what the importer must hold

Technical documentation is not a commercial formality. EU harmonisation legislation requires the manufacturer to compile and keep a file demonstrating the product's compliance: this is the common framework set by Decision No 768/2008/EC, carried through into every product directive, from the Machinery Directive 2006/42/EC to the Toy Safety Directive 2009/48/EC.

This file is only useful if it can be produced. Regulation (EU) 2019/1020 on market surveillance requires an economic operator established in the Union to be able to respond to the authorities and supply the documents demonstrating compliance, within a short deadline set by the text. Since 16 July 2021, without a reachable operator in the Union, a covered product cannot be placed on the European market.

On import, the manufacturer is in China and the operator established in the Union is you. Technical documentation becomes your concern: not writing it, but holding it or obtaining it on request, without delay.

The minimum content is set by the common EU framework: the file describes the product and how it is made, then demonstrates its compliance. Each piece serves a precise function, and the whole must stay consistent from one document to another.

A file reduced to a photo of the product and a generic certificate is not a file. The question to ask the factory is not do you have a certificate but show me the complete file for this model. The gap between the two answers reveals whether anyone actually worked on compliance.

The general rule fits in two lines. The manufacturer compiles and keeps the technical documentation for ten years after the product is placed on the market. The importer keeps a copy of the EU declaration of conformity available to the authorities, ten years as a general rule, and must supply the documents demonstrating compliance when an authority requests them.

Do not rely on a factory's memory three years down the line. Models drop out of catalogues, staff change, archives get wiped. Keep your own copy of every document received, dated and linked to the order and the product version: proforma, invoice, declaration, test reports, key exchanges.

The rule tightens if you place the product under your own brand: you are then treated as the manufacturer, and it is you who must hold the complete technical file, not just a copy of the declaration.

The same flaws recur from one file to the next. First flaw: a generic test report, written for a product family, with no reference to the model ordered. Then come a test run to Chinese GB standards, which proves nothing for the European market, a declaration citing legislation inconsistent with the product, and a technical file withheld on the grounds that it is confidential.

A common case is hidden subcontracting: you approve one factory's file, production then moves to a workshop next door, and the documents no longer match the goods shipped. A pre-shipment inspection on real samples catches this shift.

None of these flaws can be fixed after the container arrives. They are dealt with before production, in writing, in the brief and in the purchase contract.

The file is ordered like the product. List the documents expected in the brief, along with when they are due, and make this a condition of payment. Documents handed over before the balance is paid carry more weight than a verbal promise.

For a sensitive product, have the file reviewed by a laboratory or a compliance consultant before launch. This review costs a fraction of what a market withdrawal would cost.

At customs, a product without supporting documents can be suspended: the authorities request additional documents before release for free circulation, and no response prolongs the hold. Once the product is on the market, surveillance authorities can demand the documentation, carry out evaluations, impose corrective measures and publish an alert on Safety Gate, the EU's public rapid alert portal.

Penalties are set by each member state: market withdrawal, recall, fines. On top of these come the commercial costs of a recall, returns, refunds and crisis communication, in full view of your customers.

A complete file does not guarantee the product's compliance. Its absence, though, ends your defence: without documents, you can demonstrate nothing.

Sorva is a sourcing and brokerage house based in Guangzhou, with a Chinese-speaking team on the ground. On technical documentation, we step in before the order: our Chinese-speaking team in Guangzhou requests the complete file from the factory in Chinese, checks that every test report carries the reference of the model ordered and that the EU declaration of conformity cites the right legislation, then we review the consistency between the file, the sample and the actual product. If pieces are missing, we push the factory towards a recognised laboratory before launch, and we close the loop with a pre-shipment inspection to confirm the goods shipped match the file.

In most cases you pay no fees: you open a file with us, we negotiate the goods on your behalf, and we take a commission on the ex-factory value.