[F16.2.1. The manufacturer shall establish the technical documentation and make it available to the approved body referred to in point 6.4. The documentation shall make it possible to assess the instrument's conformity with the relevant requirements, 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, wherever applicable, contain at least the following elements—E+W+S
(a)a general description of the instrument;
(b)conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
(c)descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the instrument;
(d)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;
(e)results of design calculations made, examinations carried out, etc.;
(f)test reports.]
Textual Amendments
F1Schs. 6-9 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. 26 para. 45 (with Sch. 26 para. 5) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)