PART 3E+W+SConformity assessment
Presumption of conformityE+W+S
38.—(1) A product which is in conformity with a [F1designated] standard (or part of such a standard) F2... is presumed to be in conformity with the essential health and safety requirements covered by that standard (or that part of that standard).
(2) The presumption in paragraph (1) is rebuttable.
Textual Amendments
F1Word in reg. 38(1) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 25 para. 23(a) (with Sch. 25 para. 34) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in reg. 38(1) omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 25 para. 23(b) (with Sch. 25 para. 34) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
Commencement Information
I1Reg. 38 in force at 8.12.2016, see reg. 1(1)
Conformity assessment proceduresE+W+S
39.—(1) For the assessment of conformity of equipment, and where necessary those devices referred to at regulation 3(2)(b), the manufacturer must follow one of the following procedures—
[F3(a)for equipment-groups I and II, equipment-categories M1 and 1, the manufacturer must follow either—
(i)the Type-examination set out in Part 1 of Schedule 3A, in conjunction with either the procedure set out in—
(aa)Part 2 of Schedule 3A, or
(bb)Part 3 of Schedule 3A; or
(ii)the conformity based on unit verification referred to in Part 7 of Schedule 3A;]
[F4(b)for equipment-groups I and II, equipment-categories M2 and 2, the manufacturer must follow—
(i)for internal combustion engines and electrical equipment in these groups and categories the Type examination set out in Part 1 of Schedule 3A, in conjunction with either the procedure set out in either Part 4 or Part 5 of Schedule 3A;
(ii)for other equipment in these groups and categories the procedures set out in Part 6 of Schedule 3A;]
[F5(c)for equipment group II, equipment-category 3, the procedure relating to internal production control referred to in Part 6 of Schedule 3A;]
[F6(d)for equipment-groups I and II, instead of the procedures referred to in paragraphs (1)(a), (b) and (c), the manufacturer may follow conformity based on unit verification referred to in Part 7 of Schedule 3A.]
(2) The procedure referred to in paragraph (1)(a) or (d) must be used for the conformity assessment of protective systems.
(3) For the assessment of conformity of components, the manufacturer must—
(a)follow the procedures referred to in paragraph (1), with the exception of—
(i)affixing the [F7UK] marking;
(ii)drawing up of the F8... declaration of conformity;
(b)issue a written attestation of conformity which must—
(i)confirm conformity of the component with Part 2 of these Regulations,
(ii)state the characteristics of the component, and
(iii)explain how the component must be incorporated into equipment or protective systems to comply with the essential health and safety requirements.
(4) In respect of the safety aspects referred to in paragraph 13 of Schedule 1, instead of the conformity assessment procedures referred to in paragraphs (1) and (2), the manufacturer may follow the procedure referred to in [F9Part 6 of Schedule 3A].
(5) Where the procedures referred to in paragraphs (1), (2) and (4) have not been applied, the market surveillance authority, may authorise the placing on the market and the putting into service, of a product other than a component, F10... where—
(a)the market surveillance authority is in receipt of a duly justified request, requesting the placing on the market and the putting into service of a product, other than a component, and
(b)the use of that product is in the interests of protection.
(6) The manufacturer must ensure that the documents and correspondence relating to the conformity assessment procedures referred to in paragraphs (1) to (4) are in [F11English].
Textual Amendments
F3Reg. 39(1)(a) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 25 para. 24(a) (with Sch. 25 para. 34) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F4Reg. 39(1)(b) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 25 para. 24(b) (with Sch. 25 para. 34) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F5Reg. 39(1)(c) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 25 para. 24(c) (with Sch. 25 para. 34) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F6Reg. 39(1)(d) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 25 para. 24(d) (with Sch. 25 para. 34) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F7Word in reg. 39(3)(a)(i) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 25 para. 24(e) (with Sch. 25 para. 34) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F8Word in reg. 39(3)(a)(ii) omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 25 para. 24(f) (with Sch. 25 para. 34) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F9Words in reg. 39(4) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 25 para. 24(g) (with Sch. 25 para. 34) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F10Words in reg. 39(5) omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 25 para. 24(h) (with Sch. 25 para. 34) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F11Word in reg. 39(6) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 25 para. 24(i) (with Sch. 25 para. 34) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
Commencement Information
I2Reg. 39 in force at 8.12.2016, see reg. 1(1)
F12... Declaration of conformityE+W+S
40. The F13... declaration of conformity for a product must—
(a)state that the fulfilment of the essential health and safety requirements have been demonstrated in respect of the product;
(b)have the model structure set out in Schedule 6;
(c)contain the elements specified in [F14Schedule 3A to these Regulations] for the relevant conformity assessment procedure followed in respect of the product.
Textual Amendments
F12Word in reg. 40 heading omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 25 para. 25(a) (with Sch. 25 para. 34) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F13Word in reg. 40 omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 25 para. 25(a) (with Sch. 25 para. 34) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F14Words in reg. 40(c) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 25 para. 25(b) (with Sch. 25 para. 34) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
Commencement Information
I3Reg. 40 in force at 8.12.2016, see reg. 1(1)
[F15UK] MarkingE+W+S
41.—[F16(1) The UK marking must be affixed visibly, legibly and indelibly—
(a)to the product;
(b)to its data plate; or
(c)where paragraph (1A) applies, to—
(i)a label affixed to the product; or
(ii)a document accompanying the product.]
[F17(1A) For a period of 24 months beginning with IP completion day, the UK marking may be affixed to—
(a)a label affixed to the product; or
(b)a document accompanying the product.]
(2) Where [F18paragraph (1A) does not apply and] it is not possible or warranted, on account of the nature of the product, to affix the [F19UK] marking in accordance with [F20paragraph (1)(a) or (b)], the [F19UK] marking must be affixed to—
(a)the packaging, and
(b)the accompanying documents.
(3) The [F19UK] marking must be followed by the identification number of the [F21approved body] which carried out the relevant conformity assessment procedure for the product, where that body is involved in the production control phase.
(4) The identification number of the [F21approved body] must be affixed—
(a)by the [F21approved body] itself, or
(b)under the instructions of the [F21approved body], by the manufacturer or the authorised representative.
(5) The [F19UK] marking and, where applicable, the identification number of the [F21approved body] must be followed by—
(a)the specific marking of explosion protection as referred to in paragraph 5(1)(f) of Schedule 1,
(b)the symbols of the equipment-group and category, and
(c)where applicable, the other markings and information referred to in paragraph 5 of Schedule 1.
(6) Products designed for a particular explosive atmosphere must be marked accordingly.
Textual Amendments
F15Word in reg. 41 heading substituted (31.12.2020) by S.I. 2019/696, Sch. 25 para. 26(ac) (as inserted by The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 (S.I. 2020/1460), reg. 1(4), Sch. 3 para. 17(4)(b))
F16Reg. 41(1) substituted (31.12.2020) by S.I. 2019/696, Sch. 25 para. 26(a) (as substituted by The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 (S.I. 2020/1460), reg. 1(4), Sch. 3 para. 17(4)(a))
F17Reg. 41(1A) inserted by S.I. 2019/696, Sch. 25 para. 26(aa) (as inserted by The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 (S.I. 2020/1460), reg. 1(4), Sch. 3 para. 17(4)(b))
F18Words in reg. 41(2) inserted (31.12.2020) by S.I. 2019/696, Sch. 25 para. 26(ab)(i) (as inserted by The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 (S.I. 2020/1460), reg. 1(4), Sch. 3 para. 17(4)(b))
F19Word in reg. 41(2)-(5) substituted (31.12.2020) by S.I. 2019/696, Sch. 25 para. 26(ac) (as inserted by The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 (S.I. 2020/1460), reg. 1(4), Sch. 3 para. 17(4)(b))
F20Words in reg. 41(2) substituted (31.12.2020) by S.I. 2019/696, Sch. 25 para. 26(ab)(ii) (as inserted by The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 (S.I. 2020/1460), reg. 1(4), Sch. 3 para. 17(4)(b))
F21Words in reg. 41 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 25 para. 26(b) (with Sch. 25 para. 34) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
Commencement Information
I4Reg. 41 in force at 8.12.2016, see reg. 1(1)