Textual Amendments
F1Word in Sch. 3 Pt. 1 heading substituted (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. 20 para. 36(a) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
4. The technical documentation referred to in paragraph 3(c) of this Schedule must make it possible to assess the conformity of the apparatus with the applicable requirements of these Regulations and must include an adequate analysis and assessment of the risks posed by the apparatus. The technical documentation must specify the applicable requirements and cover, as far as is relevant for the assessment, the design, manufacture and operation of the apparatus. The technical documentation must contain, where applicable, at least the following elements—E+W+S
(a)a general description of the apparatus;
(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 apparatus;
(d)a list of the [F2designated] standards applied in full or in part F3... and, where the harmonised 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 a partly applied harmonised standard, the technical documentation must specify the parts of the standard that have been applied;
(e)results of design calculations made, examinations carried out, etc.;
(f)test reports.
Extent Information
E1This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F2Word in Sch. 3 para. 4 substituted (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. 20 para. 36(e)(i) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in Sch. 3 para. 4 omitted (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. 20 para. 36(e)(ii) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
4. The technical documentation referred to in paragraph 3(c) of this Schedule must make it possible to assess the conformity of the apparatus with the applicable requirements of these Regulations and must include an adequate analysis and assessment of the risks posed by the apparatus. The technical documentation must specify the applicable requirements and cover, as far as is relevant for the assessment, the design, manufacture and operation of the apparatus. The technical documentation must contain, where applicable, at least the following elements—N.I.
(a)a general description of the apparatus;
(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 apparatus;
(d)a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal and, where the harmonised 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 a partly applied harmonised standard, the technical documentation must specify the parts of the standard that have been applied;
(e)results of design calculations made, examinations carried out, etc.;
(f)test reports.
Extent Information
E2This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only