Technical documentation under the GPSR: what goes in the file and how long to keep it
Reviewed by Hatice Muazzez Bodur · Managing Director & Co-Founder, Grüner Baum GmbH
Last updated: · Published by Grüner Baum GmbH, Oppenheim (Rhenish Hesse), Germany
Technical documentation is the product file in which you, as the manufacturer, show that your product is safe. You draw it up before the product first reaches the EU market, keep it up to date and store it for ten years. It is not a certificate; it is your evidence for when a market surveillance authority asks.
This page is not legal advice; the exact legal references are listed at the end under Legal basis.
What technical documentation is
Technical documentation, often called the technical file, is a collection of documents about one product. It describes the product and the characteristics that matter for its safety. Where the product calls for it, it also records which risks the product may present and what you have done about them.
Nobody stamps this file, and it does not look the same for every product. Its content depends on the product and on the risks that are relevant to that specific product. The file for a plain phone case is therefore usually much shorter than the one for a scented candle, where fire is the issue.
Who draws up the file, and when
The manufacturer draws up the file, and does so before the product reaches the EU market for the first time. Starting only when an authority asks is too late.
Whether you count as the manufacturer yourself, for example because you sell goods under your own brand, is explained in our guide to the Product Safety Regulation.
What belongs in the file
At a minimum, the file describes the product and the characteristics that matter for assessing its safety. Depending on the product, this includes:
- the materials and components,
- the key design decisions,
- the warnings,
- what the product is meant for and how customers might realistically use it as well. The safety assessment is built on this use.
An example: for a scented candle in a glass, you describe the wax, wick, fragrance and container, plus the warnings on the label. You record that the candle is meant to burn on a firm, non-flammable surface, and you also consider that someone might put it on a windowsill under a curtain.
The risk analysis: when, and how thorough
Where the product’s possible risks call for it, the file includes a risk analysis. It describes which hazards the product could present and the measures you took in design and manufacture to remove or reduce them.
How thorough the analysis needs to be depends on the risk profile of your own product. Not every product needs the same depth: for the candle it is about fire, heat and a glass that stands firmly; for a cushion cover the list is much shorter.
Keeping the file up to date
A file that is created once and then forgotten is not enough. The documents must match the product you are selling today. So update the file when
- you change the product or a material,
- you learn of a new hazard,
- you corrected something after the product went on sale, such as a warning.
A practical tip: note the date and the reason for every change. A version history like this shows at a glance that the file is being maintained.
Keep it for ten years, hand it over on request
You keep the technical documentation for ten years. The period starts when the product was placed on the EU market. During that time, a market surveillance authority must be able to obtain the file from you on request.
So store the file in a way that lets you find and pass it on quickly, for example as a well-organised digital folder for each product. If parts of it sit only with your supplier, get copies while you are still working together.
Drawing it up versus checking it: two different tasks
Drawing up the file is the manufacturer’s task. The responsible person, meaning the business in the EU that answers to the authorities for the product, has a different one.
Whether that role is held by the importer, an authorised representative or another business in the EU, the responsible person checks that the technical documentation exists and makes sure an authority receives it on request. It does not rewrite the manufacturer’s file or repeat its risk analysis.
Who the responsible person is in your supply chain is explained on our page Responsible person and authorised representative.
Checklist for your file
Go through these points for every product:
- Product and its safety-relevant characteristics described
- Materials, components and warnings recorded, as far as they matter for the product
- Intended and realistically foreseeable use written down
- Risk analysis with countermeasures in place where the product calls for one
- Changes added with date and reason
- Storage for ten years arranged, file quickly available on request
How Grüner Baum GmbH reviews a technical file
As part of a possible mandate as responsible person, we look at the product’s technical file. We work through four questions:
- Does the product description in the file match the product actually being sold?
- Are the safety characteristics that matter for this type of product covered?
- Is there a risk analysis where the product needs one?
- Does the version history show real changes, or is it a single document that was never revised?
We discuss any gaps with the manufacturer before a written mandate is agreed. Our documentation review on eugpsr.de describes how the review works.
Related
Have your technical file reviewed
Does your product’s file need an outside check before we can act as responsible person for it? Describe your product in the form below and we will reply by email. You can read in advance what we look at first in the documentation review on eugpsr.de.
Tell us what you want to sell in the EU
A few details are enough to start. We reply by email.
Your Responsible Person: Grüner Baum GmbH, HRB 52165, Amtsgericht Mainz, Vorstädter Str. 32, 55276 Oppenheim, Germany. Managing Director: Hatice Muazzez Bodur.
Legal basis
For every topic on this page, this table gives the exact legal reference with a link to the official text. References as of 6 October 2026.
| Topic | Legal reference | Official text |
|---|---|---|
| Technical documentation before first placing on the market: description of the product, risk analysis where the risks call for it | Art. 9(2) Regulation (EU) 2023/988 (GPSR) | EUR-Lex |
| What counts in the safety assessment: design, composition, warnings, foreseeable use | Art. 3(2), Art. 6(1)(a) and (d) GPSR | EUR-Lex |
| Keeping the file up to date, ten-year retention, providing it to authorities on request | Art. 9(3) GPSR | EUR-Lex |
| Who counts as manufacturer, including own brands | Art. 3(8) GPSR | EUR-Lex |
| The responsible person’s task: checking that the technical documentation has been drawn up and making it available to authorities | Art. 16(1) GPSR; Art. 4(3)(a) Regulation (EU) 2019/1020 | EUR-Lex GPSR, EUR-Lex 2019/1020 |
| Contents, updates and retention in practice | European Commission guidelines C/2025/6233 | Guidelines |