How do I conduct a risk analysis for my product under the GPSR?

The risk analysis is part of the manufacturer's role

Under GPSR, the manufacturer is the party that prepares an internal risk analysis and technical documentation, and this applies to every product placed on the market under its own name or brand. If a party purchases a product from a supplier and only has its own logo applied to it, in most cases it is also considered a manufacturer — not a distributor — and therefore bears the same obligation as a party that has itself designed and produced the product. The same applies to anyone who substantially modifies an existing product before it is offered. This role allocation is the core of the regulation: the obligation does not follow from who physically made the product, but from who places it on the market as their own product.

A distributor — a party that resells products without putting its own name or brand on them and without modifying the product — does not bear this obligation. A distributor has other obligations within the supply chain, such as communicating safety information and not offering products known to fail to meet the requirements. Anyone acting purely as an intermediary or reseller, without any of the characteristics of a manufacturer, therefore does not prepare their own risk analysis and technical documentation.

This follows from Article 9 of the regulation

Article 9 of Regulation (EU) 2023/988 imposes the obligation to conduct an internal risk analysis and prepare technical documentation on the manufacturer, as part of their obligations in the product safety supply chain. The regulation has applied directly and identically in all twenty-seven Member States since 13 December 2024; there are therefore no national differences regarding this obligation itself. What does vary by country is the supervisory authority that in practice oversees compliance and the language in which associated safety information must be provided to the consumer — in the Netherlands it is Dutch, in Germany German, and in Belgium the language of the linguistic region where the products are supplied. The technical documentation and associated traceability records are retained for six years.