GPSR Technical File
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The General Product Safety Regulation (GPSR) is the European Union’s core framework for ensuring that all consumer products placed on the EU market meet strict safety requirements. A key part of this regulation is the obligation for manufacturers and importers to compile technical documentation, often referred to as a technical file or Digital Product Passport, as evidence that a product is safe and compliant.
What Is Technical Documentation?
Under GPSR, all manufacturers and importers must prepare product-specific technical documentation. This documentation proves that a product has been designed and manufactured in accordance with EU safety requirements and can be legally placed on the market.
It must contain enough information to demonstrate that the product is "safe" within the meaning of the GPSR.
What’s Included in the Technical File?
1. Product Identification and Description
- Clear identification: type, batch, model, or serial number
- General product description, function, materials, and intended use
2. Risk Assessment and Mitigation
- Analysis of foreseeable risks during normal or foreseeable misuse
- Description of risk mitigation measures taken
- Supporting reports or safety evaluations
3. Compliance Evidence
- List of harmonised standards or specifications used
- Test reports, certifications, and (where relevant) toxicological assessments
4. User-Facing Information
- Labels, warnings, and markings (e.g. CE mark)
- Instructions for Use (IFUs), age grading, and disposal guidance
Manufacturer Responsibilities Under GPSR
Retention Period: Technical documentation must be kept for 10 years after the product is placed on the EU market.
Availability: The documentation must be made available to EU market surveillance authorities on request.
Ongoing Compliance: For products produced in series, manufacturers must ensure every unit complies consistently with GPSR safety requirements.
The Role of the EU Responsible Person
GPSR requires that every product sold in the EU has a designated economic operator based in the EU. This Responsible Person (RP) is responsible for:
- Ensuring technical documentation is complete and up to date
- Responding to compliance inquiries from EU authorities
- Making the documentation available upon request
The Responsible Person can be:
- The EU-based manufacturer
- The importer
- An appointed EU Authorised Representative
- A fulfilment service provider (especially in online sales where no importer is involved)
The RP’s name and contact details must appear on the product, packaging, or accompanying documents.
The EU Declaration of Conformity (DoC)
The Declaration of Conformity is a mandatory component of your GPSR compliance file, especially if your product also falls under harmonised EU legislation (e.g., the Toy Safety Directive, EMC, or Low Voltage Directive).
The DoC must include:
- Manufacturer or importer name and address
- Product identification and description
- Reference to Regulation (EU) 2023/988
- List of applicable standards or technical specifications
- Name, role, and signature of the responsible person
- Date of issue
The DoC must accompany the technical file and be accessible to the EU Responsible Person, who must present it upon request from authorities.
Who Reviews the Documentation?
Technical files are not submitted for approval, but they must be made available to EU market surveillance authorities in the event of:
- Import checks
- Industry-wide audits
- Consumer safety complaints
- Online marketplace enforcement (e.g. Amazon, Temu, Shein)
These authorities assess your documentation to confirm compliance with the GPSR and applicable European safety standards.
Why It Matters
Preparing robust technical documentation isn’t just about ticking regulatory boxes — it’s about proving that your product is safe, traceable, and legally placed on the EU market. It also helps prevent delays, takedowns, or enforcement action from customs, regulators, or ecommerce platforms.
At GPSR Solutions, we help you build and maintain your technical file as part of our all-in-one compliance service - so you’re always ready to prove compliance when it matters.