Technical documentation
Before placing a product on the market, the manufacturer has to draw up technical documentation. These documents are based on the manufacturer’s risk analysis, and the amount of information the documents contain should reflect the complexity of the product and the potential risks associated with it.
A carefully prepared technical document is also a way of demonstrating to the authorities that the company has properly assessed the safety of its product. An authority may request access to the technical document. However, the technical document does not need to be delivered to the consumer with the product.
Technical documentation has to include at least the following information:
- A general description of the product.
- A description of the essential characteristics relevant to the safety of the product.
Where required by the complexity of the product or the risks related to the product, the technical documentation must also include:
- If necessary, a more detailed description of the product.
- An analysis of the possible risks related to the product and the solutions adopted to eliminate or mitigate such risks, including technical means, warning labels and instructions.
- The outcome of reports related to tests conducted by the manufacturer or by another party.
If the product is manufactured in accordance with European standards, a list of said standards have to also be included in the technical documentation. The same applies if the product has been manufactured using other documents mentioned in Article 8 of the EU GPSR.
The manufacturer is required to keep the technical documentation up to date and make it available to authorities upon request starting from the date when the product is placed on the market. The technical documentation is not checked by an authority in advance. The manufacturer has to keep the technical documentation available to market surveillance authorities for a period of 10 years after the last item of the product was placed on the market.
