GPSR Technical File
The General Product Safety Regulation (GPSR) is a pivotal framework within the European Union, ensuring that all consumer products meet stringent safety standards. Central to this regulation is the requirement for manufacturers to compile comprehensive technical documentation, commonly referred to as a technical file, also known as Digital Product Passport. This documentation serves as tangible proof that a product complies with the essential safety requirements set forth by the GPSR.
Content Overview of General Products’ Technical Documentation
For GPSR compliance, manufacturers / importers must prepare technical documentation for products placed on the EU market. The technical documentation should contain sufficient information to declare and determine whether the product is considered "safe" according to the GPSR.
A complete technical file should include:
- Labels and, if applicable, instructions for use
- A general description of the product and its essential characteristics
- An analysis of possible risks users might encounter while using the product and solutions adopted to eliminate or mitigate them, supported by relevant reports
- A list of relevant European standards followed for product manufacturing, if applicable
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Details of testing performed and toxicological assessment, if applicable
Key Components of the Technical File
1. Product Identification and Description
- Detailed information about the product, including its design, function, and intended use.
- Clear identification through type, batch, or serial numbers.
2. Risk Assessment and Mitigation
- A thorough analysis of potential risks associated with the product.
- Documentation of measures implemented to eliminate or mitigate identified risks.
3. Compliance Evidence
- A list of relevant European standards or other criteria applied during the product’s design and manufacture.
- Test reports and toxicological assessments demonstrating compliance with safety standards.
4. User Information
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Labels and, if applicable, Instructions for Use (IFUs) that provide clear guidance on the product’s operation and safety precautions.
Obligations for Manufacturers
- Documentation Maintenance: Manufacturers are required to retain the technical documentation for a period of 10 years after the product has been placed on the market.
- Accessibility: The technical file must be made available to market surveillance authorities upon request, ensuring transparency and facilitating compliance verification.
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Continuous Compliance: For products produced in series, manufacturers must ensure that each unit complies with the general safety requirements, maintaining consistency across all items.
Role of the Responsible Person
The GPSR mandates that products cannot be placed on the EU market unless there is an economic operator established within the Union responsible for specific compliance tasks. This Responsible Person can be:
- The manufacturer (if based in the EU).
- An importer.
- An Authorized Representative appointed by the manufacturer or importer.
- A fulfillment service provider, especially in cases where no importer is present, such as with online sales.
The Responsible Person’s details must be displayed on the product, its packaging, or accompanying documentation, ensuring traceability and accountability.
What About the Declaration of Conformity?
A key part of GPSR compliance is the EU Declaration of Conformity (DoC). This document is often misunderstood or overlooked, but it’s essential.
The DoC is a formal statement by the manufacturer or importer that the product complies with all applicable EU legislation. Under the GPSR, it is not just a best practice, it’s a legal requirement when your product falls under any harmonised legislation (e.g. the Toy Safety Directive, EMC Directive, Low Voltage Directive). Even if your product isn’t covered by sector-specific legislation, including a DoC strengthens your compliance position and demonstrates due diligence.
The DoC must include:
- The manufacturer’s or importer’s name and address
- A description of the product
- A reference to the relevant legislation (such as Regulation (EU) 2023/988)
- A list of applicable standards or specifications
- The name and signature of the responsible person
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The date the DoC was issued
The Declaration of Conformity must be included in or accompany the technical file and must be made available to EU authorities upon request. If you’re using an EU Responsible Person (as required under the GPSR for non-EU businesses), the RP must also have access to the DoC and be able to provide it if requested by authorities.
Who Will Review the Documentation?
Technical documentation is not generally submitted for approval but must be made available upon request by national market surveillance authorities in EU member states. These requests may arise due to:
- Routine import checks
- Targeted industry audits
- Consumer complaints or safety concerns
Market surveillance authorities assess the technical documentation to verify compliance with applicable European standards. Additionally, online marketplaces such as Amazon may request these documents, similar to how they require Declarations of Conformity for specific products.
Conclusion
Adhering to the GPSR’s technical documentation requirements is not merely a regulatory obligation but a commitment to consumer safety and product quality. By meticulously compiling and maintaining a comprehensive technical file, manufacturers not only facilitate compliance but also demonstrate their dedication to delivering safe and reliable products to the market.