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Can I conduct the risk analysis for my GPSR dossier myself?

The risk analysis is the heart of the GPSR dossier, and many entrepreneurs wonder whether they can prepare it themselves. This article shows which part you can complete yourself and where you become dependent on expertise that you usually do not have in-house.

Can I conduct the risk analysis for my GPSR dossier myself?

Partly yes, partly no. The risk analysis consists of two components that are often confused: gathering and structuring information about the product, and making a substantive judgment about what risks that product may pose and how serious they are. As an entrepreneur, you can do the first part yourself, or have it supported by a system that asks the right questions. The second part — the actual safety judgment — requires knowledge of standards, test methods and product category-specific risks that most SMEs do not have in-house.

Regulation (EU) 2023/988 requires manufacturers to assess what risks a product may pose during normal and reasonably foreseeable use. That is a broad formulation, and it is precisely this breadth that makes a good risk analysis more than a checklist to tick off. Anyone who wants to go through the entire process themselves must ask whether they are also prepared to draw the final conclusion on the product's safety. That is a different question from whether they can gather the information.

What you can do yourself

The largest part of the risk analysis revolves around facts that you as a seller or importer know, or can easily obtain: what material the product is made of, what age group it is intended for, what parts can come loose, how it is used and what instructions the manufacturer provides. This is a structuring question. Anyone who documents these details clearly per product has the basis of the dossier ready without needing a specialist.

Also, keeping track of what is already known — previous complaints, notifications from the industry, publications from supervisory authorities about similar products — is something an entrepreneur can organise themselves. A system that helps you build the right components, such as the product dossier on gpsria.eu, structures that information per article, but deliberately refrains from making a judgment on whether the product is safe. This distinction is not a minor nuance: it is precisely the part where the manufacturer's responsibility lies, and no system can take that on.

What is harder to do yourself

Assessing the likelihood of a risk occurring and the severity of the consequences if it does requires knowledge of harmonised standards or comparable product categories. Electrical appliances, children's products, cosmetics or chemical products often have additional rules alongside the GPSR, and risk assessment may depend on test results that do not simply follow from a checklist. Anyone who makes a judgment here without that background runs the risk that the analysis will be incomplete — not for lack of willingness, but because the expertise is required.

This is also precisely the point at which many entrepreneurs decide to outsource part of the work to a testing institute, an industry specialist or a lawyer familiar with the product category. Doing it yourself and outsourcing are not opposites; in practice, most companies combine both. Your own work is providing the facts and organising the process; the outsourced work is assessing what those facts mean for safety.

Where the role you hold makes the difference

How much this trade-off matters depends heavily on the role you play in the chain. A manufacturer or someone selling under their own brand bears full responsibility for the risk analysis. A pure reseller selling an existing product unchanged generally has fewer obligations in this area, though remaining alert to signals is still relevant. If you are unsure which role applies to you, you can have that clarified in a few questions before time is invested in a file that may not be needed.

For those who do qualify as a manufacturer, it is useful to know which documents are already held by the supplier and thus do not need to be prepared again in-house. Test reports, material certificates and declarations of conformity from the factory are often already available and form a direct input for the risk analysis. An overview of what is precisely needed for that is described in the knowledge base structured by topic.

What a system can and cannot do for you

An important point to keep in mind: no automation system, not even that of gpsria.eu, declares that a product complies with the law or takes over the role of EU responsible party. That remains with the manufacturer, or with the party that formally assumes this role. What a good system does do is structure the risk analysis so that nothing is overlooked, and make the process repeatable for each new product. How that structuring works exactly and where the information comes from can be read on the page where it is explained how the system is structured.

Anyone who is unsure whether their own situation calls for complete outsourcing or a combination of doing it yourself and specialist support would do well to first clarify which role and which obligations precisely apply. This prevents time being invested in a file that is not needed, or conversely, insufficient work being done on a point where responsibility clearly does lie.

The free role check from gpsria.eu provides an indication of where you stand in just a few minutes, without needing an account for that. Those who want to proceed further will find on the site what is at stake per topic and what is needed for that.

This article is general information and not legal advice.