The request usually arrives second-hand. An importer forwards a screenshot from the market surveillance authority in its country: they want the technical file for a model you have been selling for three years. You open the shared folder and find a forty-page test report, a label PDF, and a Declaration of Conformity with no date on it.
All three belong in a technical file. None of them is the file itself - which is why the request turns into a two-week panic instead of a fifteen-minute email.
The short answer
A technical file is the evidence package that sits behind a Declaration of Conformity. It shows how the product was designed, which standards were applied, what was measured, and which build the measurements describe. There is no official template and no single issuing body - the file is assembled by the company that signs the declaration, and it can be a folder, a PDF set, or a structured archive.
Three facts get confused most often:
- It is not issued by a laboratory. A lab produces test reports. The reports become one section of the file, not the file.
- It has no fixed format but has a required content list. Each directive names the elements in an annex. How you organise them is your choice; whether they are all present is not.
- The keeper is the manufacturer named on the declaration - not necessarily the factory that physically built the goods, and not the importer who is now asking you for it.
What has to be inside
The content list is written into the annexes: Annex II of the EMC Directive 2014/30/EU, Annex III of the Low Voltage Directive 2014/35/EU, Annex V of the Radio Equipment Directive 2014/53/EU. They overlap heavily. In practice a file for a mains-powered radio product needs the following, and the third column is what normally turns up instead.
| Element | Required by | What we usually find instead |
|---|---|---|
| General description, external and internal photographs, model identification | EMC Annex II(a); RED Annex V(a)(i) | A product brochure with renders |
| Design and manufacturing drawings, schematics, block diagrams, PCB layout | EMC Annex II; LVD Annex III; RED Annex V(b) | Nothing, or a single block diagram from the quotation stage |
| Critical component list or BOM, with brand and model of each safety- or EMC-relevant part | Component schemes under LVD Annex III and RED Annex V(b); authorities ask for the list | A purchasing BOM with no manufacturer names |
| Standards applied, with number, edition and date | EMC Annex II(d); RED Annex V(d) | "EN 55032" with no edition |
| Full test reports, including setup photographs and the tested configuration | All three | The summary page only |
| EU Declaration of Conformity, signed and dated, listing every applicable directive | EMC Annex IV; RED Annex VI | An unsigned Word draft |
| Label artwork and the printed manual in the language of the market | RED Annex V(a)(i),(iii); EMC Article 7(5)-(7) | A JPEG from the industrial design team |
| Risk assessment and the solutions adopted where standards were not applied in full | LVD Annex III; RED Annex III | Missing |
| Software or firmware version, where it affects compliance | RED Annex V(a)(ii) | "Latest version" |
| For radio equipment: the explanation of spectrum use and of the packaging information | RED Annex V(i) | A sentence in the manual, if anything |
Two practical notes. The file may be kept in any official EU language, but an authority can require a translation of the relevant parts. Electronic storage is acceptable if it is organised and can be produced on request - a shared drive nobody can find their way around does not meet that description.
A test report is not a technical file
The report is the strongest item in the package and often the only one a supplier keeps. Treating it as the whole file creates five gaps that show up in almost every review we do.
- The report covers one sample; the file has to cover what you ship. A report on the 12 V version says nothing about the 24 V variant, the optional battery pack, or the second adapter you started using in March. If they are in the model list, they need evidence.
- The report carries no declaration. The Declaration of Conformity is the legal act; the report is evidence that supports it. A file with a report and no signed declaration is incomplete, no matter how good the measurements are.
- Standards are listed without editions. "EN 55032" is not a reference. EN 55032:2015+A11:2020 is. A standard that has been superseded and withdrawn from the Official Journal no longer gives presumption of conformity, and a file that does not record the edition cannot show which one was applied.
- The BOM is not tied to the tested build. The lab records the critical components it saw. If your production BOM lists three approved alternatives and the report names one, the difference is yours to explain - not the lab's.
- The label and manual are the wrong version. Reports quote rated voltage, current and model designations. If the printed label says 18 W and the tested adapter was 12 W, the file contradicts the product on the shelf.
Who is "the manufacturer" when you do not make the product
Under EU product rules, the manufacturer is the entity that places the product on the market under its own name. If your brand is on the label and your company signs the declaration, you hold the manufacturer's obligations for that directive - even if you have never owned a soldering iron and the factory did all the design work.
A factory's report can therefore be technically valid and legally awkward at the same time. It proves the design; it does not make the factory the declarant for your brand. The routes through that are covered in using a supplier's test report for your own brand.
Importers carry their own obligations. Before placing the product on the market they must satisfy themselves that the conformity assessment was carried out, that the technical documentation exists, and that the marking and documents are in order. They must keep a copy of the declaration for ten years and be able to make the technical documentation available to authorities on request. Since 16 July 2021, Article 4 of Regulation (EU) 2019/1020 adds a further requirement for products under the EMC, LVD and RED: there must be an economic operator established in the EU - the manufacturer, an importer, an authorised representative under written mandate, or a fulfilment service provider - responsible for producing the documents and dealing with authorities, with its name and address on the product, packaging, parcel or an accompanying document.
Who physically holds what
| Role | What they must be able to produce | Retention |
|---|---|---|
| Brand owner / manufacturer named on the DoC | The complete file and the signed declaration | 10 years after the last unit of the model is placed on the market |
| Factory or ODM | Build records, component certificates, its own copy of reports | Usually set by contract - and never a substitute for your file |
| Importer | Copy of the DoC, and assurance that the technical file can be produced | 10 years |
| Authorised representative | DoC and technical file, at the disposal of authorities | 10 years |
| Test laboratory | Raw data, setup photographs, a copy of its report | Under its own quality system - not your legal file |
The last row causes real damage. Companies assume the lab "has everything". It does not: it is not obliged to hold your BOM, label artwork, declaration or risk assessment. If your file only ever existed inside the lab, it is gone.
How long, exactly
For CE marking the answer is ten years, and the clock does not start where most people think. Article 7(3) of the EMC Directive, Article 6(3) of the LVD and Article 10(4) of the RED all require the manufacturer to keep the technical documentation and the EU declaration of conformity for ten years after the product has been placed on the market. The RED guidance reads that as the last item of the model placed on the market. Ship a model for six years and the file obligation runs to year sixteen - not ten years from the test date, which is the single most common misunderstanding we correct.
The United States runs on a different logic. Under 47 CFR 2.938(c) the responsible party keeps the records for one year after manufacture is permanently discontinued for equipment authorised by certification, or two years for other procedures, and longer if an investigation has been notified. The trigger is the end of manufacture, not the sale date, and the periods are far shorter.
In Great Britain, regulation 7 of the Electrical Equipment (Safety) Regulations 2016 sets the same ten-year period from the day the equipment is placed on the market. Different statute, same shape.
When the request arrives
Authorities ask for the file, not for a summary of it. Five things make the response manageable.
- Read the request literally. Which model, which directive, which period of production. Sending the file for a different model is worse than asking for a week to locate the right one.
- Send an index first. One page listing each required element, the file name, and the page count. It shows the file is complete before anyone opens 300 pages, and it makes a missing item obvious to you rather than to them.
- Do not re-date anything. A declaration signed today for a product placed on the market in 2023 is a new statement, not the original. If you are re-issuing, say so in the covering note.
- State the gaps in writing. "The 2023 report is held by the laboratory; a certified copy will follow by this date" is a professional answer. Silence is not.
- Keep a record of what you sent. The next request, from another member state or two years later, will be easier.
Regulation (EU) 2019/1020 gives you a right to be heard before a measure is adopted, normally with a period of not less than ten working days except in cases of urgency. That window is for correcting a misidentification or supplying a document that was genuinely missing - not for buying time.
Four situations we see repeatedly
The adapter changed after the test
The product was tested with a 12 V/1 A adapter. Production moved to a cheaper 12 V/2 A unit from another supplier. The report still lists the original, the BOM lists both, and the file has no record of when the change happened. The measurements may well still be valid - but the file no longer describes the product being shipped, and nobody can show when the change was assessed. What a component change does to the evidence, and when it forces new measurements, is set out in changing a component after certification.
The declaration was signed by the wrong company
An ODM builds the product, its Hong Kong trading arm signs the declaration, and the buyer's brand goes on the label. The authority asks the brand for the file and receives a declaration naming a company with no role in placing the product on the EU market. The document is not a lie; it is about a different economic operator.
Firmware moved and the file did not
A companion app update raised the RF output and enabled a band that was not part of the original assessment. The file records firmware 1.0.4; the units on the shelf run 2.1.0. RED Annex V(a)(ii) asks specifically for the versions of software or firmware affecting compliance, which is precisely the item that gets left out because it changes so often. If the update affected radio parameters, the question is not only documentary - it needs a technical assessment.
The file exists but cannot be read by the reader
A complete file in Chinese, sent as a 200 MB archive with no index, to an inspector who has thirty days and no translator. Any official EU language is allowed, but the authority can require a translation of the relevant parts. An English index, declaration and report summary prevent most of this.
Rebuilding a file that was never assembled
Start from what you shipped, not from what you tested. Build the model list with production dates, collect the BOM for each variant, match each variant to a report, write the declaration for the entity that actually placed the goods on the market, attach the label and manual as printed, and put an index in front of it.
Two things cannot be reconstructed honestly: a risk assessment written before the product was sold, and test evidence for a configuration that was never measured. Label them as gaps with a date and an action. An incomplete file that is accurate survives an inspection far better than a complete-looking one that falls apart under a second question.
Where we fit
SZC-LAB is a testing laboratory. We are not a notified body and we do not issue CE certificates, because CE marking is a declaration made by the manufacturer, not a certificate issued by anyone. What we do is the evidence half of the file: testing to the applicable standards, full reports with setup photographs and the tested configuration recorded, critical component lists taken from the actual sample, so the file does not depend on anyone's memory of the project, and gap reviews of files that already exist but have never been checked against the annex lists. A gap review starts with the index: we map each required element to the document that satisfies it, flag the items that are missing rather than misfiled, and identify the ones that a fresh measurement would settle faster than another email to the factory. The output is written to be usable by someone who did not build the product - which is the only test that matters when an inspector opens it. We also check the declaration and the label against the values that were measured, since a mismatch there is the most common reason a complete file still fails a first review. What we cannot do is sign the declaration for you - that signature belongs to the manufacturer, and an inspection will ask why a laboratory signed it. The wider programme is described on our testing and certification page.
The paragraph worth remembering
A technical file is not a certificate and not a test report. It is the manufacturer's own evidence package, required by Annex II of the EMC Directive, Annex III of the LVD and Annex V of the RED, kept for ten years after the last unit of the model is placed on the market, and produced on request to a market surveillance authority. The company named on the Declaration of Conformity owns it. The laboratory only supplies one section of it. Everything else - the BOM, the drawings, the label, the manual, the risk assessment, the change record - has to come from the business that put its name on the product.
Send us the file you have - even if it is one test report, a label photo and an unsigned declaration - together with the model list and the market it is sold into. We will return a one-page index showing which required elements are present, which are missing, and which can be rebuilt from the evidence that already exists.