Sch 7 para 1
The manufacturer shall lodge an application for type examination with a single approved body of his choice. The application shall include— (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (b) a written declaration that the same application has not been lodged with any other approved body; (c) the technical documentation. The technical documentation shall make it possible to assess the instrument's conformity with the applicable requirements of these Regulations 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 instrument. The technical documentation shall contain, wherever applicable, at least the following elements— (i) a general description of the instrument; (ii) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.; (iii) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the instrument; (iv) a list of the designated standards applied in full or in part, and, where those designated standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of these Regulations, including a list of other relevant technical specifications applied. In the event of partly applied designated standards, the technical documentation shall specify the parts which have been applied; (v) results of design calculations made, examinations carried out, etc.; (vi) test reports; (d) the specimens representative of the production envisaged. The approved body may request further specimens if needed for carrying out the test programme; (e) 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 designated 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.