Does your product need a GPSR Technical File to sell in the EU?

The GPSR applies to all non-food products intended for consumers or likely to be used by consumers. It does NOT apply to food, feed, medicinal products, or products covered exclusively by sector-specific EU regulations.

This includes selling on Amazon, eBay, Etsy, or any online store shipping to EU consumers. Also applies if you use Amazon FBA in a European warehouse.

A GPSR Technical File includes an internal risk analysis, a Declaration of Conformity, applicable EN standards, and product labelling with all mandatory data (Art. 9 GPSR).

Art. 16 GPSR requires that every product sold in the EU has a responsible person established in the EU, with their name and contact details on the product or packaging.

Required: product identifier (type/batch/serial), manufacturer name + postal address + email, importer details (if applicable), EU Responsible Person details, safety warnings, age suitability if relevant.

If your product is covered by sector-specific EU legislation (toys, electronics, PPE, etc.) and already has CE marking, the GPSR still applies to risks NOT covered by that directive.

If manufactured outside the EU, the importer has additional obligations under the GPSR including verifying the manufacturer's documentation and ensuring proper labelling.