What should a GPSR product safety evidence pack include?
Build the pack around one product, model, batch, software or firmware version, and EU market route. The file should show the manufacturer or responsible operator, the product identifiers used by consumers and authorities, the risk analysis, the technical documentation, and the controls used before the product was placed or made available on the EU market.
For manufacturers, the GPSR expressly ties the technical documentation to an internal risk analysis and to the product characteristics needed to assess safety. Where product risks make it appropriate, keep the risk analysis, the chosen risk-reduction measures, test reports, and the European standards or other safety-assessment elements applied.
- Risk assessment: hazards, foreseeable use and misuse, affected consumers, severity, probability, risk level, chosen mitigations, and residual-risk decision.
- Technical documentation: general product description, essential safety characteristics, model or batch scope, design or material changes, and the technical means used to eliminate or reduce risks.
- Test and standards evidence: laboratory or visual test reports, dates, certificates where available, standards or other assessment elements applied, and notes where a standard was applied only in part.
- Warnings and instructions: product, packaging, accompanying-document, and digital safety information in the required consumer language for each market.
- Traceability: type, batch, serial or other product identifiers, manufacturer/importer/responsible-person contact details, supplier and downstream operator records, and affected stock counts where known.
Primary GPSR source for manufacturer technical documentation, product identification, warnings, complaint logs, accident reporting, traceability, distance-sale listings, marketplace duties, recalls, and Safety Business Gateway notifications.
Source for Safety Gate notification information, risk descriptions, test reports, accident or incident information, corrective measures, and risk-level assessment criteria.