EU GPSR Product Safety Assessment

Start with the legal scope. The GPSR covers products intended for consumers or likely to be used by consumers under reasonably foreseeable conditions, including new, used, repaired, and reconditioned products. Article 2 excludes listed categories and limits the Regulation where specific EU rules regulate the same safety objective. Record the covered risks, any product-specific EU law, applicable national requirements, and the reason for including or excluding each part of the assessment.

Start with the product identity that a market surveillance authority, online marketplace, importer, distributor, or support team can recognise without project context. The record should name the product, brand, model, batch or serial logic, SKU family, software or firmware version where relevant, packaging variant, intended EU markets, and the economic operator responsible for the assessment.

Then describe the product characteristics that matter for safety: design, technical features, composition, packaging, assembly or installation conditions, maintenance needs, connected-product behaviour, and any non-embedded accessory, app, charger, spare part, or other item that can affect how the product works. The assessment should separate intended use from reasonably foreseeable use and misuse, including use by consumers who are not the target user but are likely to interact with the product.

The assessment should list each identified hazard and the control that addresses it. Do not treat a warning as a substitute for a safer design where the hazard can be eliminated or mitigated technically. Warnings and instructions belong in the file only when they are necessary for safe use, are visible in the right channel, and are available in a language easily understood by consumers in the Member State where the product is made available.

For each hazard, record the safety basis used: a relevant European standard with an Official Journal reference where available, a national safety requirement where Article 7 applies, or other Article 8 material such as international standards, certification schemes, Commission guidance, state of the art, recognised scientific opinion, sector safety codes, reasonable consumer expectations, or specific safety requirements. If a standard is only partly applied, identify the exact clauses or risk categories covered. A presumption of conformity applies only to the risks and risk categories covered, and Article 7 still allows a market surveillance authority to act when evidence shows that the product is dangerous.

The manufacturer must carry out an internal risk analysis before placing the product on the market and keep technical documentation that contains at least a general description and essential safety characteristics. For products with possible risks, the record should go further: describe the risk, the solution adopted to eliminate or mitigate it, and the outcome of relevant tests conducted by or for the manufacturer.

The manufacturer must perform an internal risk analysis, but the GPSR does not prescribe one scoring matrix for every product file. Delegated Regulation (EU) 2024/3173 binds the Safety Gate Rapid Alert System and its authority risk assessments; it is not a mandatory manufacturer scoring template for every Article 9 file. If a manufacturer uses that method as its chosen evidence framework, describe each credible harm scenario, classify severity, estimate probability during the foreseeable lifetime, and record the resulting level as low, medium, high, or serious. Keep separate scenarios and use the highest resulting level for a Safety Gate notification assessment.

The assessment conclusion should be explicit: safe for release, safe only after listed controls, blocked pending evidence, dangerous and requiring corrective action, or out of GPSR scope with the reason recorded. If the product is dangerous or there is reason to believe it is dangerous, the record should identify the corrective measure, the consumers and markets affected, the supply-chain parties to notify, and whether Safety Business Gateway notification is required.

The documentation pack should be usable for release approval and later authority review. Keep it for the period required by Article 9, with a clear owner for updates, complaint intake, accident review, standards monitoring, supplier changes, and recall readiness. If a recall or safety warning is needed, the assessment should feed the consumer communication: product identification, hazard, stop-use instruction, remedy, contact route, and accessible language.

The GPSR and the cited delegated and implementing regulations are binding. Standards and certification can support the safety basis but cover only their stated risks and do not prevent authority action where evidence shows danger. The hazard table, outcome labels, and review triggers on this page are Sorena record-design recommendations, not an official approval or certification scheme.