Before placing the product on the market, the manufacturer must carry out an internal risk analysis and draw up technical documentation. The minimum file must describe the product and its essential safety characteristics. Where appropriate for the possible risks, add the risk analysis, mitigation choices, test-report outcomes, and standards or other safety elements applied.
The safety assessment must cover design, technical features, composition, packaging, assembly, installation, use, maintenance, interaction with other products, presentation, labelling, warnings, vulnerable consumer groups, food-imitating appearance, cybersecurity features where safety-relevant, and evolving or predictive functionality where applicable.
A cited European standard creates a presumption of conformity only for the risks and risk categories it covers when its reference has been published for GPSR purposes. Other standards, certification schemes, state-of-the-art evidence, and reasonable consumer expectations can inform the assessment under Article 8 but do not create the same Article 7 presumption. Authorities may still act where evidence shows that a product is dangerous.