What should be in a technical file?

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 category	Retention period	From
General consumer products	10 years	Last item placed on the market
Machinery	10 years	Last item placed on the market
Personal protective equipment	10 years	Last 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.

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

Are you unsure if this applies to your packaging?

Let us know briefly what it concerns. We will contact you regarding what we can do and the costs involved.