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What Must a GPSR Technical File Contain?

A GPSR technical file must identify the actual product and contain at least its general description and the essential characteristics that matter for its safety. Under the GPSR, the manufacturer must also finish an internal risk analysis before the product goes on the EU market.

What is the minimum content of a GPSR technical file?

The GPSR does not list seven separate documents with fixed names for every product. What goes into the file depends on the type of product and its possible risks.

ContentWhen is it required?
General description of the productIn every GPSR technical file
Essential characteristics relevant for assessing safetyIn every GPSR technical file
Analysis of the possible risksWhen the product's possible risks call for it
Solutions adopted to eliminate or mitigate those risksWhen the file contains a risk analysis
Outcome of tests conducted by the manufacturer or by another party on their behalfWhen tests are relevant to the product's risks
List of the European standards or other safety elements appliedWhen you used them to meet the general safety requirement
The parts of a standard applied only in partWhen you applied a standard or safety element only partly

What fields are in the European Commission GPSR model template?

The European Commission's 2025 business guidance contains an optional model for organising GPSR technical documentation. The model has three sections; it is not a certificate and is not compulsory.

Commission model sectionFields shown in the modelHow to use it
1. Product identificationBrand; product name; model, type, batch, serial number or another identifier; product description and picture; packaging description and pictureTie every record to the product and packaging version reviewed.
2. Product characteristics and compositionCharacteristics; material; compositionRecord the safety-relevant construction and substances at the detail needed for the product and its risks.
3. Risk analysis and mitigation measuresEach potential risk; description of that risk; measures taken to eliminate or mitigate it; applicable standards, substance rules, warnings or instructionsRepeat the risk block for every identified hazard and link each control to evidence.

The Commission model does not list a full bill of materials as a universal GPSR field. A detailed component or supplier list can still be necessary when the product's construction, risk analysis or other applicable EU legislation makes that evidence relevant. Open the official Commission model template.

How do you prepare a GPSR technical file?

The work runs through four documentable steps:

  1. Identify the product. Match the model, type, variant, materials, intended use and the essential characteristics that affect the safety assessment to a single product description.
  2. Carry out the internal risk analysis. Assess the hazards arising from the intended use and also from reasonably foreseeable use and misuse.
  3. Link the risk mitigation evidence. Connect design measures, warnings, instructions, applicable test results and the standards used to the hazards you identified.
  4. Keep version and product matched. Record clearly which product, model or product family the technical documentation covers, and update the file when something changes.

Keep the file up to date: the GPSR makes this the manufacturer's job. Your series production must also keep every unit in line with the general safety requirement.

How is the GPSR risk analysis linked to the technical file?

A GPSR risk analysis is not merely a score or an outcome class. The technical file has to show, in a traceable way, the hazard identified, how the risk was assessed, and which solution was chosen to eliminate or mitigate it. Applicable test results and standards are the evidence for that solution.

The GPSR lists what the assessment looks at: the product's characteristics, its effect on other products, its presentation and labelling, the groups of consumers who use it, and the cybersecurity features it needs. Which of these apply depends on the product.

Is independent laboratory testing mandatory for every product?

No. The GPSR does not require an independent laboratory test for every product. If the product's possible risks call for it, the file must include the results of tests carried out by the manufacturer or by another party on their behalf. Other EU laws for specific product types may set their own testing rules.

Grüner Baum does not attach an automatic laboratory-test rule to a product category or a generic risk label. The review checks whether testing is needed for the identified hazard, the claimed mitigation, the intended user, the applied standard and any product-specific legislation. Where an independent test is legally required or needed to support a safety claim, it is listed as an evidence gap before the product scope is accepted.

Is an EU Declaration of Conformity required for every GPSR product?

The GPSR alone does not require an EU Declaration of Conformity (DoC) for every consumer product. Whether you need a DoC depends on the specific EU law for your product, such as the rules for toys, electrical equipment or personal protective equipment. The EU responsible person only has to keep a DoC ready for the authorities if that law requires one.

Who prepares the technical file and how long is it kept?

Carrying out the internal risk analysis and drawing up the technical documentation is the manufacturer's duty. The manufacturer keeps the file available to the market surveillance authorities for 10 years after the product was placed on the market and hands it over on request.

The EU responsible person checks that the technical documentation has been drawn up and makes sure the documents within its mandate can be shown to the authorities. A Responsible Person service does not take the manufacturer's duties away.

Are the technical file, the label and the online product page the same thing?

No. The technical file holds the evidence that the product is safe. The product, its packaging and the online offer carry the information that consumers and authorities must see. On the product, that means a product identifier, the manufacturer's contact details and any required instructions or safety information. For online and distance sales, the GPSR also lists the details that must be visible in the offer.

What does Grüner Baum's GPSR technical-document review cost?

Grüner Baum GmbH charges €129 per product family for the optional Formal Technical Documentation Audit & Written Gap Report, which goes beyond the initial technical-documentation verification and document-gap check already included in the annual Responsible Person fee. The review covers existing product information, risk records, test reports and technical documents. Products subject to specific EU legislation or requiring a wider scope receive a separate quote.

The €129 review produces a written gap record. It does not take over the manufacturer's duty to prepare the file, and it is not a promise to write the full file for you. See the GPSR technical-documentation review service, compare all GPSR compliance services, or send the product records through the assessment request form.

Frequently asked questions about GPSR technical documentation

Is the European Commission GPSR technical-documentation template compulsory?

No. Commission Notice C/2025/6233 says the model template can help manufacturers draft and organise technical documentation and is not compulsory. Your file must still meet the GPSR rules for the actual product.

Is a bill of materials mandatory in every GPSR technical file?

No. The GPSR does not require a bill of materials for every product. The Commission model asks for product characteristics, material and composition. A detailed component list may still be needed when the product, the risk analysis or other EU law makes it relevant.

Who prepares GPSR technical documentation?

The manufacturer. It carries out the internal risk analysis and draws up, updates and keeps the technical documentation. A consultant may structure or review the evidence, but the manufacturer's duty does not pass to the consultant.

Does every product need an independent laboratory test?

No. The GPSR asks for test reports only where the product's possible risks make them appropriate. EU laws for specific products may separately require testing or a conformity assessment.

Can one GPSR technical file cover several SKUs?

Only if the same description and evidence really cover the relevant design, materials, intended users and safety characteristics. A safety-relevant change needs a documented review and, where necessary, an updated assessment.

Official sources

TopicLegal basisOfficial text
Risk analysis before market placement; minimum content of the fileGPSR Art. 9(2), first subparagraphRegulation (EU) 2023/988, current consolidated text — EUR-Lex
Risk analysis, solutions adopted and test resultsGPSR Art. 9(2)(a)Regulation (EU) 2023/988, current consolidated text — EUR-Lex
Standards or other safety elements appliedGPSR Art. 9(2)(b)Regulation (EU) 2023/988, current consolidated text — EUR-Lex
Standards applied only in partGPSR Art. 9(2), final subparagraphRegulation (EU) 2023/988, current consolidated text — EUR-Lex
Keeping the file up to date, 10-year retention, handing it over on requestGPSR Art. 9(3)Regulation (EU) 2023/988, current consolidated text — EUR-Lex
Series production in line with the general safety requirementGPSR Art. 9(4)Regulation (EU) 2023/988, official text
Aspects for assessing safetyGPSR Art. 6Regulation (EU) 2023/988, official text
Product identifier, manufacturer contact details, instructions and safety informationGPSR Art. 9(5) to (7)Regulation (EU) 2023/988, current consolidated text — EUR-Lex
Information visible in online and distance offersGPSR Art. 19Regulation (EU) 2023/988, current consolidated text — EUR-Lex
EU responsible personGPSR Art. 16Regulation (EU) 2023/988, current consolidated text — EUR-Lex
Tasks of the EU responsible person, including the DoC where requiredRegulation (EU) 2019/1020, Art. 4(3)Regulation (EU) 2019/1020, Article 4 — EUR-Lex
Optional model template for technical documentationCommission Notice C/2025/6233European Commission: guidance on the application of the GPSR by businesses

This guide is general information, not legal advice; the rules for your product depend on its category and on the roles in your supply chain.

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Hatice Muazzez Bodur — Grüner Baum GmbH

Founder & CEO · GPSR Responsible Person

Hatice Muazzez Bodur is the founder and CEO of Grüner Baum GmbH, a Germany-based company. Under the GPSR (Regulation (EU) 2023/988), she delivers EU Responsible Person services where a written mandate is the appropriate Article 16 route for the product and supply chain. She is an ISO 9001 auditor; our team also has auditing experience aligned with ISO 27001 and 42001 principles. Our work is carried out within these three principles. Advisory services in Turkish, German, and English. Grüner Baum GmbH (HRB 52165, Amtsgericht Mainz), located at Vorstädter Str. 32, 55276 Oppenheim, Germany, provides EU Responsible Person documentation and a direct communication channel with market surveillance authorities for the agreed product and mandate scope.

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