EU GPSR Product Safety 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.

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 file 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.

Use a risk format that can be compared with Safety Gate logic if a later notification or authority request arises. For each hazard, describe the shortest credible harm scenario, score the severity of harm, estimate the probability during the foreseeable lifetime of the product, and record the resulting level as low, medium, high, or serious. Where several harm scenarios exist, keep each scenario separate and use the highest risk level for escalation decisions.

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 file 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.