GPSR Technical Documentation: What Article 9 Requires
Reviewed by Hatice Muazzez Bodur · Managing Director & Co-Founder, Grüner Baum GmbH
Published: September 1, 2026 · Updated: September 1, 2026
A manufacturer's file, not a certificate
Article 9 of the GPSR requires the manufacturer to compile technical documentation for a product before it is placed on the EU market. The file is working evidence for a market surveillance authority, not a single stamped certificate, and its content depends on the product and the risks that are actually relevant to it.
What the file needs to contain
At minimum, the documentation describes the product and the characteristics relevant to assessing its safety. Depending on the product, this can include materials, components, design choices, warnings, and the intended and reasonably foreseeable use the safety assessment was based on.
A risk analysis, where the product calls for one
Where relevant to the product category, the file includes an analysis of the risks the product could present and the measures taken during design and manufacture to address them. Not every product needs the same depth of analysis; what is appropriate follows from the product's own risk profile.
Keeping the file current
Article 9 is not satisfied by a document produced once and left unchanged. Design changes, newly identified hazards, and corrective actions taken after the product is on the market all belong in an updated file, so the documentation continues to reflect the product actually being sold.
Ten years of retention
The manufacturer keeps the technical documentation for ten years after the product, or the last unit of a batch, was placed on the market, and must be able to produce it within a reasonable time if a market surveillance authority asks for it.
Two different duties: compiling versus verifying
Compiling the technical documentation under Article 9 is the manufacturer's duty. It is a separate matter from the duty an EU-established responsible economic operator carries under Article 16, whichever role that operator holds: to check that the documentation exists and appears complete, and to make it available to an authority on request. The responsible person does not write the manufacturer's file or repeat its risk assessment; it verifies and holds a copy for compliance answering.
How Grüner Baum GmbH reviews a technical file
As part of a possible Article 16 engagement, we check that the product description in the file matches the product actually sold, that the safety characteristics relevant to the product category are addressed, that a risk analysis is present where the product calls for one, and that version history reflects real changes rather than a single unchanged document. Any gaps are raised with the manufacturer before a written mandate is agreed.
Grüner Baum GmbH's technical documentation review on eugpsr.de
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Next step
If a product's technical file needs an outside check before it supports an Article 16 mandate, the documentation review on eugpsr.de explains what we look at first.