anx_III__cpt_1__cpt_1__cpt_3__cpt_1

1.3.1. The application shall include the following: the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; a written declaration that the same application has not been lodged with any other notified body; the technical documentation. The technical documentation shall make it possible to assess the appliance's or fitting's conformity with the applicable requirements of this Regulation and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the appliance or the fitting. The technical documentation shall contain, wherever applicable, at least the following elements: a general description of the appliance or the fitting; conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.; descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the appliance or the fitting; a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Regulation, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied; results of design calculations made, examinations carried out, etc.; test reports; instructions for installation and use of the appliance; the EU declaration of conformity of the fitting containing the instructions on how the fitting should be incorporated into an appliance or assembled to constitute an appliance; the specimens representative of the production envisaged. The notified body may request further specimens where needed for carrying out the test programme; the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.

← anx_III__cpt_1__cpt_1__cpt_3__text_2 · All articles · anx_III__cpt_1__cpt_1__cpt_3__cpt_1__text_1 →

Source: EUR-Lex (Cellar) · retrieved 2026-11-01 · Text as adopted (Official Journal); later amendments are not incorporated in this text.