If you sell or want to sell products in the European Union, technical documentation is not an optional formality. It is the body of evidence that supports your product's compliance with applicable legislation, and it is the first thing a market surveillance authority, a marketplace, or a B2B customer may ask you for. In products with CE marking, this set of documents is commonly referred to as the technical file — although official EU sources use the term technical documentation — and it must be ready before the product enters the European market, not after.
This article explains what it is exactly, what it must include, when it applies, and what happens when it is missing or poorly prepared.
Who this guide is for and when it applies
This guide is useful if:
- You manufacture consumer products outside the EU and want to export to the European market.
- You are an importer or distributor and are not sure whether the documentation provided by the manufacturer is sufficient.
- You sell on marketplaces such as Amazon, eBay or Bol and have received requests for technical or compliance documentation.
- Your product carries CE marking but you are not confident the technical file would withstand a real review.
- You have a signed EU Declaration of Conformity but do not know whether there is technical documentation to back it up.
What is the technical file for a product
The technical file — or product technical documentation, as official EU sources call it — is the organised set of documents that demonstrates a product has been designed, evaluated, and documented in accordance with applicable legal requirements. It is not a single document or a form to be filled in: it is a structured dossier containing all the documentary evidence of conformity.
Its function is specific: if a competent authority, a notified body, or even a marketplace asks for proof that your product complies with applicable legislation, the technical documentation is what you must present. Without it, the EU Declaration of Conformity — the document you sign to affix CE marking — has no real foundation.
Technical file, technical documentation and EU Declaration of Conformity: key differences
These three concepts cause a great deal of confusion. It is worth being clear on them before discussing content:
Technical documentation / technical file:
this is the evidence dossier. It contains all the documents that justify that the product is compliant. It remains in the manufacturer's possession and is not sent to customers; it is only presented to authorities when requested.
EU Declaration of Conformity (DoC):
this is a public document that the manufacturer signs and formally declares that the product complies with applicable legislation. It is based on the technical documentation, but does not replace it. Without a solid technical file behind it, the DoC is a declaration without substance.
CE marking:
this is the mark that appears on the product or its label. It indicates that the manufacturer has completed the required conformity assessment procedure and that a supporting DoC exists. It is not an external certificate: the manufacturer applies it under their own responsibility.
A common mistake is to present a DoC to an authority as though it were sufficient. The technical documentation is the real basis of conformity; the DoC is only its formal expression.
When it applies and when it does not
The obligation to prepare technical documentation exists for all products covered by harmonised EU legislation that requires CE marking. The exact content varies according to the legislation applicable to each product category.
However, there is a situation that many manufacturers overlook: not all consumer products carry CE marking. For consumer products not covered by specific sectoral legislation requiring CE, the applicable framework is Regulation (EU) 2023/988 on general product safety (GPSR), which entered into application on 13 December 2024, replacing the previous General Product Safety Directive.
Under the GPSR, manufacturers are also required to carry out a risk assessment and prepare technical documentation demonstrating the safety of their products. The documentation must be kept up to date and made available to market surveillance authorities for a period of ten years from when the product was placed on the market.
In summary:
- Product covered by harmonised legislation requiring CE: technical documentation is mandatory as part of the conformity assessment procedure defined in that legislation.
- Consumer product without specific sectoral legislation requiring CE: technical documentation is mandatory under the GPSR to demonstrate product safety.
- Product not intended for end consumers and not covered by sectoral legislation: depends on the applicable framework; no generalisation is possible.
If you are not sure which framework applies to your specific product, the first step is a review of the regulatory scope before preparing any documentation.
What a correct technical file must include
There is no single universal closed list that applies equally to all products. The exact content depends on the applicable sectoral legislation. That said, the technical documentation must gather, at minimum, the information necessary to:
1. Identify the product
manufacturer's name and contact address, product description, models or variants, serial number or identification reference.
2. Describe the design and technical characteristics
materials, components, relevant drawings or diagrams, technical specifications affecting safety or compliance.
3. Demonstrate the conformity assessment carried out
documented risk evaluation and analysis, indicating the risks identified and how they have been addressed in the design, materials, warnings, or instructions.
4. Gather test reports and technical evidence
test reports justifying compliance with applicable requirements. If harmonised standards or technical references have been used, these should be identified and the extent to which they have been applied should be stated.
5. Include labelling, instructions, and conformity documentation
labels in the required languages, instructions for use or safety, and the EU Declaration of Conformity where applicable.
6. Maintain a change history
if the product has changed in terms of materials, components, software, or design, the changes must be recorded and the documentation updated accordingly.
⚠️ The specific content required depends on the product and the applicable legislation. This list reflects elements commonly required under harmonised legislation and the GPSR, but it does not replace an analysis of the specific regulatory framework for each product.
Which documents, data and evidence are most commonly missing
In practice, most problems do not arise from a complete absence of documents. They arise from incomplete, inconsistent, or outdated dossiers. The most common gaps we find when reviewing technical files are:
Generic or copied risk assessment:
one of the most frequent failures. The risk analysis must refer to the specific product, its intended use, and the users it is aimed at. A generic template with no real connection to the product has no probative value.
Test reports that do not correspond to the actual product:
the reports may be properly issued but may refer to a different version of the product, different materials, or a different model from the one actually sold. Inconsistency between the physical product, the labelling, and the test reports is one of the first things authorities check.
Instructions and labels that are not up to date or lack translation:
the technical documentation must include versions of labels and instructions in the languages of the markets where the product is sold. Instructions in English when the product is sold in France, Germany, or Italy is a frequent documentary gap.
EU Declaration of Conformity without documentation to back it up:
signing a DoC without having the technical file prepared is a real risk. If an authority asks for the supporting documentation, there is nothing to present.
Documentation not updated following product changes:
when a manufacturer changes the supplier of a component, modifies materials, or updates the design, the technical documentation must be updated accordingly. If it is not, the file no longer reflects the product that is on the market.
How to prepare the technical file step by step
There is no single correct order, but there is a documentary logic that makes the process more manageable:
Identify the applicable legislation.
Before preparing anything, you need to know which regulatory framework applies to the product: whether there is a sectoral directive or regulation requiring CE, or whether the product falls within the scope of the GPSR without mandatory CE marking. This step conditions everything else.
Gather existing documentation.
Test reports, technical specifications, material data sheets, labels, instructions, any prior evidence. From there it is possible to identify what is missing and what needs to be completed or updated.
Carry out or review the risk assessment.
It must refer to the specific product, take into account the intended use and the reasonably foreseeable use, identify the relevant risks, and document how they have been addressed.
Organise the documentation in a structured way.
The technical documentation must be organised so that any piece of evidence can be located quickly. Without structure, a dossier with many documents can be just as indefensible as an empty one.
Verify consistency between product, tests, labelling, and documentation.
The product being sold, the one described in the test reports, the one referenced in the DoC, and the one covered by the instructions must all be the same product. Inconsistencies are the first point of scrutiny in any critical review.
Prepare or review the EU Declaration of Conformity.
where applicable, ensuring it reflects the correct legislation and is signed by the appropriate person.
Retain documentation and manage changes.
Technical documentation is not a static document. It must be updated if the product changes and retained for the period required by applicable legislation (under the GPSR, ten years from when the product was placed on the market).
💡 Not sure whether your current technical documentation is solid enough to withstand a real review? An early review of the technical file helps identify gaps before a request, a customs hold, or a marketplace incident occurs. You can find out how we work at Conformity Point.
Who can request the technical file and what happens if you do not have it
The responsibility for preparing and maintaining technical documentation rests with the manufacturer. If the manufacturer is established outside the EU, the GPSR provides for the figure of the EU responsible person — governed by Regulation (EU) 2023/988 — whose appointment is mandatory in certain circumstances. Under the CE marking framework, the manufacturer may appoint an EU authorised representative to act on their behalf with regard to certain obligations, although the underlying responsibility for product conformity always remains with the manufacturer.
Technical documentation must be ready before the product enters the market. These are the parties who can request it and the direct consequences of not being able to present it:
Market surveillance authorities
they can request it at any time. If you cannot present it, or what you present is inconsistent, the product may be withdrawn from the market during the investigation. This is the highest-risk scenario.
Customs
in certain situations they may require evidence of compliance as a condition for clearance. Lack of documentation can result in holds, additional costs, and delivery delays.
Marketplaces
Amazon, Bol, and other platforms have active compliance verification processes. An incomplete or inconsistent technical file can lead to the suspension of a listing or a seller account, with no time margin to prepare the documentation.
B2B customers and notified bodies
distributors, institutional buyers, and notified bodies where their involvement is required by legislation. Inability to respond can block contracts or certification processes.
In all cases, if the technical file is weak and a real incident arises, preparing the documentation from scratch under time pressure is costly and sometimes means repeating tests that could have been avoided. And if the product causes harm, the absence of documented risk assessment seriously undermines the position of the manufacturer or importer.
Common mistakes that undermine conformity
Relying solely on the EU Declaration of Conformity.
The DoC is the result of the conformity assessment process, not the process itself. Having it signed without the technical documentation to support it is like having a signature without the contract.
Using templates without real adaptation to the product.
There are many available templates for risk assessments and technical files. The problem is using them as they are, without connecting them to the specific product. A generic risk assessment has no real probative value.
Not updating documentation after changes.
Changing the supplier of a raw material, updating the software of a connected product, or modifying a component design without updating the technical file is one of the most common and hardest-to-defend failures before an authority.
Test reports that do not reflect the product currently being sold.
Tests carried out on a prototype or on an earlier version of the product, not updated after changes, do not cover the product currently on the market.
Incomplete labelling or instructions, or in the wrong language.
The technical documentation must include versions of labels and instructions in the languages of the countries where the product is sold. Not having them, or having only the English version, is a documentary gap that authorities detect quickly.
Not knowing which legislation actually applies to the product.
Preparing a technical file for the wrong framework — for example, applying only the GPSR when the product requires sectoral CE marking, or vice versa — produces a dossier that does not serve to demonstrate the conformity that needs to be demonstrated.
Frequently asked questions about technical files and technical documentation
What to keep in mind before selling in Europe
The technical file is not a bureaucratic formality: it is the documented proof that your product is what it claims to be. Having it properly prepared is what separates a solid market entry from one that can fall apart at the first real request. Before selling in the EU, it is worth being clear on:
- Which legislation applies to your specific product (sectoral CE marking, GPSR, or both).
- What the technical documentation must include in your specific case.
- Whether the tests and evidence you have reflect the product actually being sold today.
- Whether there is consistency between the physical product, labelling, instructions, and conformity documentation.
- Who is the responsible person in the EU if the manufacturer is based outside European territory.
If you need to prepare or review the technical file for your product to sell in the EU, at Conformity Point we help manufacturers, importers, and brands identify documentary gaps, organise evidence, and reduce risks before a real request arises. If you sell without an establishment in the EU and also need an EU Responsible Person, you can find out about our EU Responsible Person service.
Need help with your technical file?
At Conformity Point we help manufacturers, importers and brands prepare, review and organise their technical files — so the documentation is solid before a real request arises.
Learn more about Conformity PointThis article provides general information about the European regulatory framework. Each product may be subject to specific requirements. Always consult a specialist to assess your specific case.
Author
Written by Juan Manuel Beltrán, Founder & Product Compliance Consultant at Conformity Point. Specialist in consumer product compliance for the European market, he helps manufacturers, importers, and brands sell consumer products in Europe.
Last updated: March 2026