What must be included in a GPSR technical file?
The GPSR technical file — sometimes called the technical documentation or, informally, the Digital Product Passport — is the central compliance document required by Article 9 of Regulation (EU) 2023/988. It must contain enough information for an EU market surveillance authority to independently determine whether the product is safe. The file has no mandatory format, but the European Commission published a template as part of its Guidelines C(2025) 7699 (released 19 November 2025) to help businesses structure their documentation.
According to Article 9.2, the technical file must include at minimum: a general description of the product and its essential characteristics relevant to safety assessment; an internal risk analysis identifying all foreseeable hazards and the measures taken to eliminate or reduce each one; a list of the applicable European harmonised standards (EN standards) used to demonstrate conformity, or — where no standard exists — a description of the approach taken; results of tests or evaluations carried out, where relevant; the product's labelling, including all safety warnings and instructions for use in the language of each country where it is sold; traceability information linking the product to a specific batch, lot, or serial number; and the manufacturer's and Responsible Person's contact details. A Declaration of Conformity should be included or referenced wherever sector-specific legislation requires one.
The depth and extent of the technical file should be proportional to the complexity and risk profile of the product — a simple kitchen utensil requires less documentation than a children's ride-on toy. What is not proportional is the obligation itself: every product in scope must have a file, regardless of how simple it is. The file must be kept available for 10 years and must be producible within 10 days of an authority's request.
What the law says
Article 9.2 of Regulation (EU) 2023/988 sets out the minimum content of the technical documentation. Article 9.4 requires the file to be retained for 10 years from the date the product was last placed on the market. The Commission's Guidelines C(2025) 7699 provide a practical template for structuring the documentation.
Consequences of non-compliance
Failing to produce the technical file within 10 days of an authority's request is itself an infringement of the GPSR — even if the product is objectively safe. EU customs can block imports. Marketplaces can remove listings. Fines of up to €100,000 apply per Member State. Without the file, demonstrating due diligence in a product liability claim is also significantly harder.
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