Paragraph 4 E1

England, Wales and Scotland

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—

(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 F1designated standards applied in full or in part F2... 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.

Annotations

Textual amendments

F1: Word 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)
F2: Words 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)

Extent

E1: This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Notes on Part 1

Textual amendments

F1: Word 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)