Recital 33

(33) Manufacturers should draw up technical documentation regarding the products they place on the market, which should contain the necessary information to prove that those products are safe. The technical documentation should be based on an internal risk analysis carried out by the manufacturer. The amount of information to be provided in the technical documentation should be proportionate to the complexity of the product and the possible risks identified by the manufacturer. In particular, manufacturers should provide a general description of the product and the elements necessary to assess its safety. In the case of complex products or products presenting possible risks, the information to be provided might need a more extensive description of the product. In such cases, an analysis of those risks and the technical means adopted to mitigate or eliminate the risks should also be included. Where the product complies with European standards or other elements applied to meet the general safety requirement laid down in this Regulation, the list of the relevant European standards or the other elements should also be indicated.

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Source: EUR-Lex CELLAR · retrieved 2026-08-26 · Text as adopted (Official Journal); later amendments are not incorporated in this text.