3.

The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice. The application shall include: 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 conformity of the pressure equipment with the applicable requirements of this Directive 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 pressure equipment. The technical documentation shall contain, wherever applicable, at least the following elements: a general description of the pressure equipment, conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc., descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment, a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards have not been 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, information concerning the tests provided for in manufacture, information concerning the qualifications or approvals required under points 3.1.2 and 3.1.3 of Annex I, the specimens representative of the production envisaged. The specimen may cover several versions of the pressure equipment provided that the differences between the versions do not affect the level of safety. The notified body may request further specimens if 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 by the appropriate laboratory of the manufacturer applying other relevant technical specifications, or by another testing laboratory on his behalf and under his responsibility.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-02 · Text as adopted (Official Journal); later amendments are not incorporated in this text.