The EU declaration of conformity is defined in the reference provisions of Decision No 768/2008/EC, which the product directives and regulations of the New Legislative Framework copy into their own text. Article R10 of Annex I states that the declaration shall state that fulfilment of the requirements of the relevant legislation has been demonstrated, that it follows the model structure in Annex III, that it contains the elements specified in the applicable conformity assessment module, and that it must be kept up to date and translated into the languages required by the Member State where the product is placed or made available. By drawing it up, the manufacturer assumes responsibility for the compliance of the product.
Article R2(2) of the same Annex links the declaration to the process behind it: the manufacturer draws up the technical documentation, carries out the conformity assessment procedure, and only where that procedure has demonstrated compliance draws up the declaration and affixes the CE marking. The model in Annex III asks for the product identification, the name and address of the manufacturer or authorised representative, the legislation applied, the harmonised standards or other specifications used, the notified body where relevant, and a dated signature.
For an importer or a responsible person under Article 4 of Regulation (EU) 2019/1020, the practical duty is to verify that the declaration has been drawn up, keep it at the disposal of market surveillance authorities for the period required, and be able to produce it on request. Under the Toy Safety Regulation, which applies from 1 August 2030, the digital product passport replaces the separate declaration where it contains all the information the declaration requires.