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What should be in a technical file?

Technical File By Francois Frietman 7 minuten lezen
Short answer

A technical file contains everything required to demonstrate that your product meets the applicable requirements: a product description, the applied standards, a risk assessment, test reports, the instructions for use, and the declaration of conformity.

Why you need it

The technical file is the evidence supporting your declaration of conformity. Without a file, that declaration is a claim you cannot substantiate. A supervisory authority or a buyer can request it. You must then be able to show the basis of your declaration within the legal timeframe.

The technical file is the substantiation for your declaration of conformity. You declare that your product complies. The file is the evidence with which you can substantiate that declaration. Without a file, the declaration is merely a claim.

That distinction only becomes visible the moment someone asks for it. This could be a supervisory authority, but in practice, it is more often a buyer or a marketplace requesting it before listing your product.

Which components should be included

A technical file contains a description of the product, the design drawings, a risk assessment, the applied standards, the test reports, the instructions for use, and the declaration of conformity itself. The composition varies per regulation, but these components are found in almost every file. Keep them together so you can present them all at once.

The exact content varies per regulation, but the core is the same everywhere. These components are found in almost every file:

  • A description of the product, including the model and the variants covered by it.
  • Design and manufacturing drawings, to the extent necessary to understand the operation.
  • A risk assessment detailing the hazards you have identified and what you have done to mitigate them.
  • The applied standards, stating which parts you have followed.
  • Test reports demonstrating that the product meets those standards.
  • The instructions for use and safety information in the language of the country of sale.
  • The declaration of conformity itself, signed by you as the manufacturer.
Product categoryRetention periodFrom
General consumer products10 yearsLast item placed on the market
Machinery10 yearsLast item placed on the market
Personal protective equipment10 yearsLast item placed on the market
Retention period per product category

How long you must keep it

You must keep the technical file for ten years, calculated from the moment you placed the last item on the market. So, not from the production date and not from the first sale. If you modify the product, that period starts again for that version.

The general rule is ten years, calculated from the moment you placed the last item on the market. Not from the production date. Also not from the first sale.

Note regarding product modifications

If you change something about the product, the period starts again for that version. In practice, this means: keep a separate file for each model variant. Not one single file for a series that has been adapted over the years.

What usually goes wrong

The most common mistake is a file that appears complete but does not belong to the product actually being sold. This happens as soon as a supplier adapts the design without the documentation being updated. The test report then belongs to an earlier version.

The most common mistake is a file that appears complete but does not belong to the product actually being sold. This happens if a supplier adapts the design without the documentation being updated.

  1. The test report belongs to an earlier version of the product.
  2. The risk assessment is missing or consists of a completed template without product-specific hazards.
  3. The instructions for use have not been translated into the language of the country of sale.
  4. The file is held by the manufacturer in Asia and not by you, even though your name is on the product.

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    Further reading
    Technical File
    The declaration of conformity: what is it exactly?
    CE
    Is a notified body mandatory?

    Prefer not to figure it out yourself?

    We prepare technical files for brands and manufacturers, from the risk assessment to the declaration you sign. Fixed price in advance.

    View the CE process
    Sources
    Legislation verified on August 16, 2026
    Francois Frietman
    Founder of Declaer

    Legal expert with a background in e-commerce. Writes about the regulations he applies daily in cases for brands and manufacturers. More about Francois

    Frequently Asked Questions

    Does the file have to be in Dutch?
    No. The file itself may be in a language accepted by the supervisory authority, which in practice is often English. However, the instructions for use and safety information must be in the language of the country where you are selling.
    Is my supplier allowed to keep the file?
    They may keep it, but the responsibility remains yours as soon as your brand is on the product. You must be able to present it within a reasonable timeframe, so ensure you have a copy yourself.
    What happens if I do not have it?
    A supervisory authority can have the product withdrawn from the market and impose a fine. In practice, you are more likely to encounter this with a buyer or marketplace that blocks your listing until you provide it.