EU GPSR safety assessment workflow

Start with the product facts that decide whether GPSR applies and which actor owns the file. GPSR covers products intended for consumers or likely to be used by consumers under reasonably foreseeable conditions, including products supplied in the context of a service. It also covers new, used, repaired, and reconditioned products unless a product is clearly marked as needing repair or reconditioning before use.

If another Union rule contains specific safety requirements for the same product, record which risks are covered by that rule and which remaining consumer safety risks stay in the GPSR assessment. Distance sales are in scope when the offer targets consumers in one or more Member States.

The risk evaluation should connect product characteristics to plausible harm. Do not start with a score. Start with the product's physical, mechanical, chemical, electrical, digital, packaging, labelling, and presentation features, then describe how each hazard could lead to an accident or adverse health effect during the product's foreseeable lifetime.

For each hazard, write the shortest credible harm scenario: defect or dangerous situation, accident or adverse effect, and resulting harm. Use the intended user first, then add scenarios for foreseeable misuse or users who are more exposed to the risk.

Use standards to support, not replace, the safety assessment. If a referenced European standard covers the relevant risk category, record the exact standard and the product evidence showing conformity. If no standard covers a hazard, or if a standard covers only part of the risk, explain the additional controls, design changes, tests, instructions, or warnings used to meet the general safety requirement.

Warnings and instructions are residual-risk controls. They do not cure a design hazard that can reasonably be eliminated or reduced. The file should show which risk remains after design and testing, why the warning is needed, and whether the warning is accessible to the consumers likely to use the product.

The release decision should be traceable to the product file. GPSR expects manufacturers to draw up technical documentation containing the information necessary to prove the product is safe, based on an internal risk analysis and proportionate to product complexity and identified risks.

For simple low-risk products, the file may be short. For complex products or products presenting possible risks, include a fuller product description, risk analysis, and the technical means used to eliminate or mitigate risks. If the product relies on standards or other elements to meet the general safety requirement, list them in the documentation.

The assessment is not finished at launch. Complaints, accidents, test failures, authority contact, supplier changes, marketplace notices, or new evidence can require the file to reopen and can trigger notification, withdrawal, recall, or online-content removal work.

For accidents, Article 20 requires notification through the Safety Business Gateway when a product caused death or serious adverse health and safety effects. For dangerous products and corrective measures, Member States use Safety Gate notifications; economic operators and online marketplaces should keep the evidence that allows authorities to understand the risk, products affected, distribution, corrective action, and consumer communication.