b)

The manufacturer who: It must be clear that it is always the manufacturer who takes responsibility for the conformity of his products with the relevant legislative requirements. In this respect, the economic operator that places the product on the market under its name or trademark becomes automatically the manufacturer for the purposes of Union harmonisation legislation. Therefore he takes the entire responsibility for the conformity assessment (design and production) of the product, even if this has been actually done by somebody else. Furthermore he must be in the possession of all documentation and, where relevant, certificates necessary to demonstrate the conformity of the product, but these do not need to be under his name. designs, manufactures and tests the product or has it designed, manufactured or tested; draws up the technical documentation of the product; takes all measures necessary to ensure compliance of the products; upon positive assessment of the products, draws up the EU Declaration of Conformity and affixes the CE marking on the products if the legislation so requires; upon intervention of a notified body, affixes the notified body’s identification number to the product if the legislation so requires.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-25 · Text as adopted (Official Journal); later amendments are not incorporated in this text.