Textual Amendments
F1Schs. 1-7 inserted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 15 para. 43 (with Sch. 15 para. 3) (as amended by S.I. 2020/676, regs. 1(1), 2 and S.I. 2020/1460, reg. 1(4), Sch. 3 para. 9(5)); 2020 c. 1, Sch. 5 para. 1(1)
2. The manufacturer must establish the technical documentation. The documentation must make it possible to assess the product's conformity to the relevant requirements, and must include an adequate analysis and assessment of the risk(s). The technical documentation must specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation must, wherever applicable, contain at least the following elements:
— a general description of the product,
— 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 product,
— a list of the designated standards and/or other relevant technical specifications applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the enactments where those designated standards have not been applied. In the event of partly applied designated standards, the technical documentation must specify the parts which have been applied,
— results of design calculations made, examinations carried out, etc., and
— test reports.]