Ask a Chinese manufacturer for its technical file and you will very often receive a test report: a few pages, a laboratory letterhead, a list of measurements, a pass. The report is genuine, it probably cost real money, and it is not what was asked for. It records that one sample behaved in one way on one day under one standard. The technical file is the argument that the product, as it is produced, conforms — and that argument is written by the manufacturer, not by a laboratory.
A test report and a technical file are different documents
The report is evidence. The file is the case. A report answers « did this sample pass this test »; the file answers « why is this product safe, against which requirements, and how do you know production still matches the sample ». That is why a file contains reports and a stack of reports never becomes a file. It also explains the most common failure: a product is modified — a cheaper component, a new supplier, a different plastic — and the report still says pass, because it tested something that is no longer what you ship. A file that is maintained catches that. A folder of reports does not.
Who can require it, and how fast you have to produce it
The market surveillance authority of any member state where the product is sold can require it, and it addresses that request to whoever is designated to answer for the product in the Union. Customs can hold a consignment while the question is open. A chain retailer will ask for it during supplier admission, a distributor will ask before taking a range, and an insurer will ask after an incident. The legislation sets a period within which the file must be made available, and that period is written to be short: it assumes the file already exists and only has to be handed over. Nobody is given time to build one. The practical consequence is that the deadline is never the problem — the absence is.
What is actually inside a technical file
- A description of the product and its variants. What it is, what it is for, which models and references the file covers, and what distinguishes them. A file that covers « the range » without saying which references belong to it covers nothing.
- A risk assessment. The hazards the product can present in normal use and in the misuse that can reasonably be expected, what was done about each, and what residual risk is handled by a warning instead of by design. This is the part factories skip and the part authorities read first.
- The standards applied, named. Which standards were used, in which version, and for which requirement each one answers. Where a standard was not followed, the file says what was done instead and why it achieves the same level of safety.
- Drawings, diagrams and calculations. Plans, circuit diagrams, component lists with the references actually purchased, and the calculations behind any claim about strength, capacity or load. This is also where a cheaper substituted component becomes visible.
- The test reports, and what they tested. The laboratory reports, with the identification of the samples, so that someone reading the file can tell whether what was tested is what is being sold.
- The signed declaration of conformity. A declaration in which an identified company states, under its own responsibility, that the product meets the legislation that applies to it. Signed by someone who can commit the company, with a name and a function, not by an unnamed quality department.
- Where applicable, what a notified body produced. For the product families where an independent body has to be involved, its certificate or examination document belongs in the file. Where no body is required, nothing is missing — that case is treated elsewhere in this cluster.
How long it has to survive, and who has to be able to open it
The retention period is set by the legislation that applies to the product, and it runs from the last unit placed on the market rather than from the date of the test. That single detail catches almost everybody: a reference discontinued long ago still has a live file obligation, because somewhere a unit was sold later than you remember. The file also has to be available to the authorities through the party designated in the Union, which means availability is not the same as existence. A file on a laptop that left with an engineer, in a format nobody can open, on a server whose password retired with its administrator, exists and is not available.
The factory that never built one because no customer asked
This is the usual situation, and it is not negligence. A factory that has shipped season after season to European trading companies was asked for a price, a sample and a test report, and it delivered all three. The buyer was the importer, the buyer carried the obligation, and the buyer built whatever file existed — or did not. Then something changes: the factory sells under its own brand, or direct to consumers online, or the trading company disappears and its customer comes straight to the plant. The obligation moves with the role, and it arrives at a company that has reports going back several seasons and no risk assessment at all. Reconstructing a file for a product already being sold is possible. It is slower, it is more expensive, and it is done while somebody is waiting for an answer.
- Take your best-selling reference and ask one question: where is its risk assessment. If the answer is a test report, you have found the gap and you have found it cheaply.
- List which references the existing reports actually cover, by sample identification, and mark the ones where the product has changed since. Those are the files that will not hold.
- Write the risk assessment before paying for new tests. It tells you which tests are worth buying, and it is the document that makes the rest of the file coherent.
- Decide who signs the declaration of conformity, with a name and a function. An unsigned declaration, or one signed by a department, is treated as no declaration.
- Put the file where the party designated in the Union can open it without calling China, and check once that they actually can.
Do not build the file for the authority. Build it for the engineer who replaces you and has to explain a product they did not design. If that person can read the file and say why the product is safe, which standards were used and what was tested, an inspector will reach the same conclusion faster. Keep it where your European responsible person can open it alone, and keep it after the reference is discontinued, since the retention obligation runs from the last unit placed on the market and the exact period depends on the legislation that applies to your product.