How to Prepare Your Technical Documentation for GPSR Compliance?
Selling consumer products in the European Union now requires meeting stricter safety obligations under the General Product Safety Regulation (EU) 2023/988 (GPSR). For manufacturers, one of the most critical, and often misunderstood, requirements is developing complete, structured technical documentation that can demonstrate safety and regulatory compliance at any time.
EARP, as an EU Authorized Representative (AR) and Responsible Person (RP), EARP routinely supports manufacturers with this process. This article explains why thorough technical documentation matters, what it should contain, and how to approach its preparation to ensure GPSR compliance and smooth market access.
ANSWERED ON THIS PAGE
- Why technical documentation is required
- What authorities look for
- How have expectations changed for technical files
- What complete GPSR technical documentation include
Why is Technical Documentation required under the GPSR?
Under GPSR, manufacturers are explicitly required to carry out an internal risk analysis and draw up technical documentation before placing their products on the market. According to Article 9(2), this documentation must include at least a general description of the product and its essential characteristics relevant for assessing its safety.
But the expectation goes beyond minimal formality. The Regulation further clarifies that the amount of information provided should be proportionate to the complexity of the product and the possible risks identified through that risk analysis. In other words, manufacturers are expected to demonstrate that they understand their product’s design, use, and associated hazards and that they have taken appropriate measures to ensure its safety under normal and foreseeable conditions.
It must be structured so that EU authorities and your Responsible Person can quickly verify that all safety requirements are met. Failing to provide this evidence can lead to fines, loss of market access, and reputational damage.
How have expectations changed for EU Technical Files?
Many manufacturers still approach EU compliance with outdated habits viewing technical files as an afterthought or mere formality. GPSR changes that expectation. Today’s technical documentation needs to stand up to real regulatory scrutiny. Common pitfalls we see include:
- Generic or boilerplate risk assessments that don’t address product-specific hazards.
- Outdated or missing testing records.
- Disorganized files that make traceability impossible.
- Labeling inconsistencies between packaging, instructions, and declarations.
- Grouping unrelated models into a single “family” without justification.
Under GPSR, these gaps are no longer acceptable. Authorities expect manufacturers to demonstrate real ownership of safety planning, supported by clear, current, and well-organized documentation.
What authorities look for
When authorities assess safety, they don’t stop at test data. They also consider how the product is presented to consumers: labeling, warnings and instructions (including disposal), age suitability, foreseeable misuse, packaging, and for software products the interconnectivity or software aspects that can affect safety. Make sure your file connects these dots so the reasoning from hazard to control is obvious.
What does complete GPSR Technical Documentation include?
A robust GPSR-compliant technical documentation file must be rooted in an internal risk analysis that the manufacturer carries out before the product is placed on the market. This is not an optional step but a clear legal obligation
The depth and detail of the documentation should be proportionate to the complexity of the product and the risks identified in that analysis. This means simple, low-risk products may require less extensive documentation, while complex or higher-risk products demand more comprehensive evidence and justification. For manufacturers, this translates into preparing a clear, professional, and well-organized record that can demonstrate that you have systematically considered safety at every stage.
With that in mind, at its core, your technical documentation should establish who is responsible, what the product is, how it is manufactured, which risks have been assessed and controlled, and what evidence supports its safety under normal and foreseeable use. Typically, this includes administrative details identifying the manufacturer and RP, clear descriptions of the product’s design, materials, intended use, and any variants or accessories. It should also cover how the product is labeled and instructed for use, with attention to language and market requirements. Read about more information about the GPSR labeling requirements.
Perhaps the most critical part is the risk assessment. Under GPSR, authorities expect more than boilerplate disclaimers. Your file should show a structured, product-specific analysis that identifies hazards, evaluates severity and likelihood, considers foreseeable misuse, and documents mitigation measures. This is the cornerstone of demonstrating that the product is “safe under normal and reasonably foreseeable conditions.” Read more about conducting a risk analysis. Evidence should support safety claims, with testing records, certificates, and references to any applied harmonized standards. Manufacturing and design processes, supplier controls, and quality procedures also form part of this complete picture.
Ultimately, well-prepared technical documentation is your evidence that your products are safe, compliant, and ready for the EU market and it’s an essential foundation for any Authorized Representative and Responsible Person to accept their role with confidence.
Keep it living, not static
Treat the file as a living record. Update it whenever there is a design change, a material/component change, new test evidence, a serious complaint, or a corrective measure. Under the GPSR, the EU-based Responsible person must be able to check that the product complies with the technical documentation and with labeling/traceability duties. Keep the latest version therefore accessible to your Responsible Person at any time.
Best practices for structuring your documentation
Start with a plain-language product description, then document hazards and risk estimates, followed by the measures you chose (guards, construction limits, software controls, warnings). Attach instructions for safe use, maintenance and disposal, labeling layouts, photos of markings, test plans and reports, and the list of standards or other solutions you relied on.
Further, to ensure your technical documentation is GPSR-ready, keep in mind to:
- Organize logically: Use clear sections and consistent version control.
- Demonstrate traceability: Cross-reference supporting files, test reports, and design records.
- Avoid generic content: Tailor risk assessments and safety analyses to your specific product.
- Maintain currency: Review and update documentation regularly, especially after design or process changes.
- Plan for language requirements: Ensure all labeling and IFUs meet local language obligations across EU markets.
How EARP supports
As an independent EU Authorized Representative and Responsible Person, EARP helps you meet your obligations under the GPSR with confidence. Our service includes:
- Structured onboarding with clear documentation guidance.
- Professional feedback on file organization and family groupings.
- Verification of labeling and AR requirements.
- Coordination of safety events and reporting and authority communications.
- Post-market surveillance support where needed.
Read more about EARP’s representation services.
Building trust through compliance
GPSR compliance is more than ticking boxes. It is a commitment to consumer safety, regulatory transparency, and market trust. Manufacturers that invest in thorough, well-structured technical documentation not only reduce regulatory risk, but also position themselves as credible, reliable partners for distributors, retailers, and consumers alike.
At EARP, we stand ready to help you navigate these requirements with clarity and confidence.
FAQs
Your internal technical documentation itself doesn’t usually need to be translated for every market. However, any parts that authorities may review (like Instructions for Use or labeling samples) must demonstrate compliance with local language requirements. Ensure that user-facing materials are available in the appropriate languages for each EU market where the product is sold.
You can group products into a single “family” in your technical documentation if they share the same design, intended use, and risk profile. However, you’ll need to justify this grouping clearly. If certain models have unique features or risks, they may require separate documentation or distinct sections to address those differences.
Make sure you include current and relevant test reports in your technical documentation. This means using the latest applicable standards and demonstrating that testing reflects the current product design. Expired, outdated, or mismatched certificates can trigger authority questions.
Any significant change such as design updates, new materials, different suppliers, or changes to intended use, require a review and update of your technical documentation. It’s good practice to maintain change control records and re-evaluate risk assessments as part of your quality system, showing that you continue to ensure the product’s safety throughout its lifecycle.
While GPSR doesn’t mandate formal certification like ISO 9001, having documented quality processes is strongly recommended. Authorities and your Authorized Representative will expect to see consistent procedures for document control, change management, complaint handling, and post-market surveillance. Even smaller businesses benefit from defining clear internal procedures to maintain reliable, inspection-ready records.
