GPSR technical documentation and risk analysis

What the documentation contains

At least a general description of the product and its essential characteristics relevant for assessing its safety. Where the possible risks call for it, also:

• an analysis of the possible risks and the solutions adopted to eliminate or mitigate them, including the results of tests by you or others on your behalf;
• the list of European standards or other elements applied to meet the general safety requirement, and which parts were applied if only partly.

The amount of detail follows the product: a simple product needs a short file, a complex or risky one a fuller analysis.

What the risk analysis looks at

Article 6(1) lists the aspects to consider, among them the product's design, composition and packaging; its effect on other products it is used with, including interconnection; its labelling, warnings and age suitability; vulnerable users such as children, older people and persons with disabilities; products that look like food or appeal to children; and, where relevant, cybersecurity and evolving or learning functions.

Conformity with a European standard published in the Official Journal gives a presumption of safety for the risks that standard covers (Article 7).

Other manufacturer duties

• keep the documentation up to date and available for 10 years after the product is placed on the market (Article 9(3));
• procedures so series production stays safe (Article 9(4));
• a type, batch or serial number on the product (Article 9(5));
• your name and postal and email address on the product, its packaging or an accompanying document (Article 9(6));
• clear instructions and safety information in a language consumers understand in each country of sale (Article 9(7));
• a public channel for complaints and accident reports, and a register of complaints and recalls (Article 9(11) and (12)).

Selling under your own name or brand makes you the manufacturer, even when someone else makes the product. So does substantially modifying a product (Article 13).

The GPSR check builds this list for your role, as a checklist you can copy or print.