GPSR Technical Documentation Example: A Practical Guide for Compliance
The General Product Safety Regulation (GPSR), Regulation (EU) 2023/988, requires manufacturers of consumer products within its scope to prepare and maintain Technical Documentation demonstrating that the product complies with the general safety requirement. This documentation must be kept available to market surveillance authorities for at least 10 years after the product has been placed on the market.
The level of detail should be proportionate to the complexity of the product and the risks associated with it. Below is a practical example of what a well-structured GPSR Technical Documentation file may include, together with additional records required under applicable EU product legislation.
What is GPSR Technical Documentation?
GPSR Technical Documentation is a structured set of records used to demonstrate that a consumer product is safe. Under Article 9 of the GPSR, manufacturers must carry out an internal risk analysis and prepare technical documentation before placing the product on the EU market.
The documentation must contain at least a general description of the product and the essential characteristics relevant to assessing its safety. Where appropriate in relation to the identified risks, it should also contain an analysis of possible risks, the measures adopted to eliminate or mitigate those risks, and relevant European standards or other technical specifications used to demonstrate safety.
Additional documentation may be required where the product is also subject to sector-specific EU legislation such as the Radio Equipment Directive, Low Voltage Directive, EMC Directive, Toy Safety legislation, RoHS, REACH, the Batteries Regulation, or other applicable rules.
Why is GPSR Technical Documentation Important?
- Compliance Evidence: Demonstrates how the manufacturer has assessed and controlled product-safety risks.
- EU Market Access: Technical documentation must be available before a covered product is placed on the EU market.
- Market Surveillance: Authorities may request the documentation when investigating a product or checking compliance.
- Marketplace Compliance: Online marketplaces such as Amazon and eBay may request test reports, labels, declarations, or other compliance evidence.
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Risk Management: Proper documentation can reduce the risk of recalls, listing removals, market restrictions, and regulatory penalties.
GPSR Technical Documentation Structure – Example Breakdown
1. Product Description and Identification
Provide a clear overview of the product and information allowing it to be identified and distinguished from other products or variants.
- Product name, model number, type, SKU, batch, or serial identification
- Intended use and reasonably foreseeable use
- Target user group, including vulnerable consumers where relevant
- Technical specifications, dimensions, ratings, and key functions
- Materials and construction
- Product photographs, drawings, or diagrams
- Packaging photographs and label artwork
Example:
- Product Name: Wireless Bluetooth Speaker
- Model Number: WBB-988
- Intended Use: Portable wireless audio device for indoor and outdoor consumer use
- Connectivity: Bluetooth wireless communication
- Power Source: Rechargeable lithium-ion battery
2. Bill of Materials (BOM) and Material Information
A Bill of Materials can provide important evidence regarding the composition of the product and help link materials and components to supplier declarations, test reports, Safety Data Sheets, and other supporting documents.
Depending on the product, include:
- Component name and function
- Material type and exact grade where available
- Supplier or manufacturer
- Component part number
- Relevant coatings, adhesives, inks, finishes, or treatments
- Battery chemistry and specifications where applicable
- Supplier declarations or material specifications
Example:
- Speaker Housing: ABS plastic, Supplier ABC Plastics Ltd, Part No. 123-456
- Printed Circuit Board: FR-4 laminate, Supplier DEF Electronics, Part No. 789-101
- Rechargeable Battery: Lithium-ion battery pack, model and supplier documented in the BOM
- USB Charging Cable: Supplier and material specifications recorded separately
3. Safety and Risk Assessment
The manufacturer must carry out an internal risk analysis. It should identify relevant hazards, affected users, foreseeable use and misuse, risk levels, and the measures adopted to eliminate or reduce those risks.
Depending on the product, hazards may include:
- Mechanical or physical injury
- Electrical shock
- Fire and overheating
- Battery hazards
- Chemical exposure
- Choking or ingestion
- Sharp edges or entrapment
- Cybersecurity risks where connectivity can affect product safety
- Risks arising from evolving or software-controlled functions
Example:
- Hazard Identified: Battery overheating during charging
- Potential Consequence: Burns, fire, or damage to the product
- Mitigation: Battery-management system, thermal protection, charging controls, suitable cell selection, testing, and appropriate user instructions
4. Test Reports and Supporting Compliance Evidence
Include test reports, assessments, specifications, declarations, and other evidence supporting the conclusions of the risk assessment and demonstrating compliance with applicable legislation.
Examples may include:
- EN 71 series for toys where applicable
- EN IEC 62368-1 for certain audio/video and ICT equipment where applicable
- Radio and EMC standards for Bluetooth, Wi-Fi, or other radio-enabled equipment
- RoHS evidence relating to restricted substances in electrical and electronic equipment
- REACH chemical testing or supplier declarations where applicable
- Battery safety and transport documentation where relevant
Example for the Wireless Bluetooth Speaker:
- Electrical Safety Test Report covering the applicable safety standard
- Radio Test Report covering the Bluetooth radio function
- EMC Test Report covering electromagnetic compatibility
- RoHS Test Report or Technical Evidence covering restricted substances
- Battery Documentation including relevant safety and transport evidence
Test reports should clearly identify the tested product, model, sample, materials, and applicable standard or method. Generic certificates that cannot be linked to the actual product are generally weak evidence.
5. User Instructions and Safety Information
Provide the information consumers need to install, use, maintain, charge, clean, store, and dispose of the product safely.
- Assembly or installation instructions
- Operating instructions
- Charging instructions where applicable
- Maintenance and cleaning information
- Storage and environmental conditions
- Safety warnings and precautions
Example Warnings:
⚠ WARNING: Risk of fire or overheating. Use only a compatible charging source and do not charge the product if damaged.
⚠ WARNING: Keep batteries and small removable parts away from young children where a choking or ingestion hazard exists.
⚠ WARNING: Do not expose the product to conditions exceeding the specified operating or charging limits.
Warnings must be based on the actual product risk assessment. Generic warnings should not be added without considering whether the identified hazard genuinely applies to the product.
6. Traceability and Economic Operator Information
The technical documentation should clearly identify the economic operators involved and allow the product and its supply chain to be traced.
- Manufacturer name, postal address, and electronic address
- Importer details where applicable
- EU Responsible Person or responsible economic operator details where applicable
- Supplier and manufacturing-site information where relevant
- Product model, batch, type, serial number, or other traceability identifier
- Production and batch records where appropriate
Example:
- Manufacturer: ABC Electronics Pty Ltd, Brisbane, Australia
- EU Responsible Economic Operator: EaseCert GmbH, Germany, where properly appointed and applicable
Under Article 16 of the GPSR, products covered by the Regulation must have an economic operator established in the EU responsible for the relevant compliance functions. Depending on the supply chain, this may be the EU manufacturer, importer, authorised representative, or, in certain circumstances, an EU fulfilment service provider.
7. Declaration of Conformity (Where Required)
An EU Declaration of Conformity is not a universal standalone requirement for every GPSR product.
A formal EU Declaration of Conformity is required where applicable EU harmonisation legislation specifically requires one. This includes many CE-marked product categories such as toys, radio equipment, electrical equipment, machinery, and personal protective equipment.
Where required, the declaration normally includes:
- Manufacturer name and address
- Product identification
- A statement that the declaration is issued under the sole responsibility of the manufacturer
- Applicable EU legislation
- Applicable harmonised standards or other technical specifications
- Notified body information where relevant
- Place and date of issue
- Name, position, and signature of the authorised signatory
Example for the Wireless Bluetooth Speaker:
A Bluetooth-enabled speaker would normally require an EU Declaration of Conformity under applicable EU radio-equipment legislation and any other relevant harmonisation legislation. The declaration should identify those applicable legal acts and standards rather than simply state compliance with the GPSR.
A GPSR-only product that is not subject to legislation requiring an EU Declaration of Conformity still requires appropriate technical documentation and an internal risk analysis.
8. Post-Market Monitoring, Complaints and Incident Procedures
The compliance file should also document how product safety will be monitored after the product enters the market.
- Monitor complaints and product-safety feedback
- Record accidents and safety incidents
- Investigate suspected product defects
- Implement corrective actions where required
- Withdraw or recall dangerous products where necessary
- Notify competent authorities through the Safety Business Gateway where legally required
Manufacturers should also maintain procedures ensuring that products manufactured in series continue to meet the applicable safety requirements.
9. Packaging and Labelling Compliance
Retain copies of the final product labels, packaging artwork, instructions, and other consumer-facing information within the technical file.
Depending on the applicable legislation, labels may need to include:
- Clear product identification
- Manufacturer name, postal address, and electronic address
- EU Responsible Person information for non-EU manufacturers where applicable
- Batch, serial, type, model, or another traceability identifier
- Relevant safety warnings
- CE marking where required by applicable EU harmonisation legislation
- WEEE, battery, textile, recycling, or other regulatory markings where applicable
Warnings and safety information must be provided in a language that can be easily understood by consumers, as determined by the Member State where the product is made available.
Packaging also needs to be assessed separately for environmental obligations, including national packaging EPR requirements and the Packaging and Packaging Waste Regulation (EU) 2025/40 (PPWR), where applicable.
10. Digital Information and Digital Product Passport Requirements
Businesses may use QR codes or other digital links to provide supplementary product information, instructions, compliance information, or safety resources. However, a voluntary QR code linking to documentation is not the same as an EU Digital Product Passport (DPP).
The Digital Product Passport framework is established primarily under Regulation (EU) 2024/1781, the Ecodesign for Sustainable Products Regulation (ESPR). DPP obligations apply progressively to product groups where specific delegated acts or other EU legislation require them.
Depending on the applicable product rules, a DPP may include:
- Unique product identification
- Manufacturer and economic operator information
- Material and composition data
- Sustainability and environmental information
- Recycled content
- Durability and repairability information
- Compliance documentation
- Recycling and end-of-life information
A DPP is not currently required for every GPSR product. Businesses should assess whether their specific product category is subject to an existing or upcoming DPP requirement.
Prepare for the EU Digital Product Passport
EaseCert helps manufacturers, importers, and online sellers prepare the product data, technical documentation, traceability information, and compliance records needed for upcoming Digital Product Passport obligations under the ESPR and other EU legislation.
- DPP applicability and product-scope review
- Product and economic operator identification
- Materials, composition, and supply-chain data review
- Technical and compliance documentation assessment
- Gap analysis for ESPR and product-specific DPP requirements
- Structured data preparation for future DPP implementation
Checklist for GPSR Technical Documentation
Before finalising your technical documentation, check whether the following information is relevant and complete:
- Clear product description and identification
- Product specifications and photographs
- Bill of Materials or relevant material information
- Documented internal risk assessment
- Risk mitigation measures
- Relevant test reports and supporting compliance evidence
- Applicable legislation, standards, and technical specifications
- User instructions and safety warnings
- Manufacturer, importer, and EU Responsible Person information where applicable
- Product and batch traceability information
- EU Declaration of Conformity where required by applicable legislation
- Final product and packaging labels
- Post-market monitoring, complaint, incident, and recall procedures
- Environmental compliance records such as REACH, RoHS, WEEE, batteries, or packaging where applicable
- Digital Product Passport information where applicable to the product category
How Long Must GPSR Technical Documentation Be Kept?
Under Article 9 of Regulation (EU) 2023/988, manufacturers must keep the technical documentation at the disposal of market surveillance authorities for 10 years after the product has been placed on the market.
Importers must verify before placing a product on the market that the manufacturer has prepared the required technical documentation.
Documentation should also be reviewed whenever changes to the design, materials, components, supplier, production process, software, intended use, standards, or other relevant characteristics could affect the product’s safety or compliance.
Conclusion
Creating comprehensive GPSR Technical Documentation is an essential part of demonstrating that a consumer product is safe and compliant with EU requirements. The technical file should clearly identify the product, document its risk assessment, provide supporting evidence, and show how identified risks have been eliminated or reduced.
The exact contents depend on the product. A simple household product may require relatively limited documentation, while a Bluetooth speaker, toy, electrical product, connected device, or other regulated product may require extensive testing and documentation under several pieces of EU legislation.
For tailored support with GPSR compliance, including risk assessments, technical documentation preparation, label reviews, EU Responsible Person services, and product-specific compliance assessments, EaseCert provides support throughout the EU market-access process.
Ensure Your Compliance & Maintain EU Market Access
If your manufacturer is established outside the EU, make sure the product has the required EU responsible economic operator before it is placed on the market. Download our GPSR checklist for a step-by-step overview of product safety, labeling, technical documentation, traceability, and market-access requirements.
Partner with EaseCert for GPSR technical documentation and EU Responsible Person support.
Learn More About GPSR:
- Regulation (EU) 2023/988 – General Product Safety Regulation
- EU Product Safety and GPSR Overview
- EU Safety Gate – Rapid Alert System for Dangerous Products
- Regulation (EU) 2024/1781 – Ecodesign for Sustainable Products Regulation (ESPR)
- European Commission – Technical Documentation and EU Declaration of Conformity