Every act built on the New Legislative Framework requires the manufacturer to draw up technical documentation and to carry out, or have carried out, the applicable conformity assessment procedure (Decision No 768/2008/EC, Annex I, Article R2(2)). The documentation must make it possible to assess the conformity of the product with the relevant requirements and must include an adequate analysis and assessment of the risks. As a rule it contains a description of the product and its intended use, design and manufacturing drawings, the list of harmonised standards or other specifications applied, the results of design calculations and examinations, and test reports; the exact content is set out in each act.
The documentation must exist when the product is placed on the market. The reference provisions of Decision No 768/2008/EC set the retention period at ten years from the placing on the market (Articles R2(9) and R4(3)), and most product acts copy it — but the applicable act governs, and several set a different period or a different starting point, so the period has to be read off the legislation for the product in question. Where the product has been redesigned, the file must cover all versions so that an authority can match a product on the market to the right documentation.
Under Article 4(3) of Regulation (EU) 2019/1020 the economic operator responsible in the EU must ensure that the technical documentation can be made available to market surveillance authorities on request. The General Product Safety Regulation extends the idea to non-harmonised consumer products: Article 9(2) requires the manufacturer to carry out an internal risk analysis and draw up technical documentation containing at least a general description of the product and its essential characteristics relevant for assessing its safety, and Article 16(2) requires the responsible person to check that the product complies with it.