The Electromagnetic Compatibility Regulations 2016

PART 2 U.K. Obligations of economic operators

Essential requirements U.K.

7.  A person must not make equipment available on the market or put equipment into service unless it complies with the essential requirements.

Manufacturers U.K.

Duty to ensure apparatus complies with the essential requirements U.K.

8.  Before placing apparatus on the market, a manufacturer must ensure that it has been designed and manufactured in accordance with the essential requirements.

Technical documentation and conformity assessment U.K.

9.  Before placing apparatus on the market, a manufacturer must—

(a) carry out a relevant conformity assessment procedure in respect of the apparatus or have such a procedure carried out; and

(b) draw up—

(i) the technical documentation referred to in Schedule 2 (module A: internal production control) or Schedule 3 (module B: [F1 EU-]type examination and module C: conformity to type based on internal production control); and

(ii) any other technical documentation required as part of the relevant conformity assessment procedure to demonstrate the means used by the manufacturer to ensure that the apparatus complies with the essential requirements.

Textual Amendments

F1 Word in reg. 9(b)(i) omitted (E.W.S.) (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. 20 para. 6 (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 Declaration] of conformity and [F3 UK] marking E+W+S

10.—(1) Where the conformity of apparatus with the essential requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the apparatus on the market—

(a) draw up [F4 a] declaration of conformity in accordance with regulation 41 F5 ...; and

(b) affix the [F6 UK] marking in accordance with regulation 42 ([F6 UK] marking).

(2) The manufacturer must keep the F7 ... declaration of conformity up-to-date.

[F8 (3) Where apparatus is subject to more than one enactment requiring the drawing up of a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment concerned by its title.]

Extent Information

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

Textual Amendments

F2 Word in reg. 10 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. 7(a)(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)

F3 Word in reg. 10 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. 7(a)(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)

F4 Word in reg. 10(1)(a) 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. 7(b)(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)

F5 Words in reg. 10(1)(a) omitted (E.W.S.) (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. 20 para. 7(b)(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)

F6 Word in reg. 10(1)(b) 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. 7(c) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F7 Word in reg. 10(2) omitted (E.W.S.) (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. 20 para. 7(d) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F8 Reg. 10(3) substituted (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. 7(e) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

EU declaration of conformity and CE marking N.I.

10.—(1) Where the conformity of apparatus with the essential requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the apparatus on the market—

(a) draw up an EU declaration of conformity in accordance with regulation 41 (EU declaration of conformity); and

(b) affix the CE marking in accordance with regulation 42 (CE marking).

(2) The manufacturer must keep the EU declaration of conformity up-to-date.

(3) Where apparatus is subject to more than one [F41 NI Protocol obligation] requiring a declaration of conformity to be drawn up, the manufacturer must draw up a single declaration of conformity, which—

(a) identifies the [F42 relevant] EU instruments; and

(b) includes references to the publication of [F43 the relevant EU] instruments in the Official Journal.

Textual Amendments

F41 Words in reg. 10(3) substituted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 8 para. 3(1)(a)

F42 Word in reg. 10(3)(a) inserted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 8 para. 3(1)(b)

F43 Words in reg. 10(3)(b) substituted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 8 para. 3(1)(c)

Retention of technical documentation and [F9 EU] declaration of conformity U.K.

11.  A manufacturer must keep the technical documentation and the [F10 EU] declaration of conformity (as referred to in regulation 41) drawn up in respect of the apparatus for a period of 10 years beginning on the day on which the apparatus is placed on the market.

Textual Amendments

F9 Word in reg. 11 heading omitted (E.W.S.) (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. 20 para. 8 (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F10 Word in reg. 11 omitted (E.W.S.) (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. 20 para. 8 (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Compliance procedures for series production E+W+S

12.—(1) A manufacturer of apparatus which is manufactured by series production must ensure that, before placing apparatus on the market, procedures are in place to ensure that any apparatus will be in conformity with Part 2.

(2) In doing so, the manufacturer must take adequate account of—

(a) any change in the design or characteristics; and

(b) any change in a [F11 designated] standard or in another technical specification by reference to which the F12 ... declaration of conformity was drawn up.

Extent Information

E2 This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F11 Word in reg. 12(2)(b) 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. 9(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)

F12 Word in reg. 12(2)(b) omitted (E.W.S.) (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. 20 para. 9(b) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Compliance procedures for series production N.I.

12.—(1) A manufacturer of apparatus which is manufactured by series production must ensure that, before placing apparatus on the market, procedures are in place to ensure that any apparatus will be in conformity with Part 2.

(2) In doing so, the manufacturer must take adequate account of—

(a) any change in the design or characteristics; and

(b) any change in a harmonised standard or in another technical specification by reference to which the EU declaration of conformity was drawn up.

Information identifying manufacturer E+W+S

13.—(1) Before placing apparatus onto the market, a manufacturer (“M”) must ensure that the following appear on the apparatus—

(a) a type, batch or serial number or an element which identifies M as the manufacturer of the apparatus;

(b) the name, registered trade name or registered trade mark of the manufacturer; and

(c) a postal address at which the manufacturer can be contacted.

(2) The manufacturer must include the relevant information specified in paragraph (1) on the packaging of the apparatus or in a document accompanying the apparatus where—

(a) due to the size or nature of the apparatus, it is not possible for the information in paragraph (1)(a) to appear on the apparatus; or

(b) it is not possible for the information in paragraphs (1)(b) or (1)(c) to appear on the apparatus.

(3) The postal address in paragraph (1)(c) must indicate a single point at which the manufacturer can be contacted.

(4) The information specified in paragraphs (1)(b) and (1)(c) must be [F13 clear, legible and in easily understandable English].

Extent Information

E3 This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F13 Words in reg. 13(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. 10 (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Information identifying manufacturer N.I.

13.—(1) Before placing apparatus onto the market, a manufacturer (“M”) must ensure that the following appear on the apparatus—

(a) a type, batch or serial number or an element which identifies M as the manufacturer of the apparatus;

(b) the name, registered trade name or registered trade mark of the manufacturer; and

(c) a postal address at which the manufacturer can be contacted.

(2) The manufacturer must include the relevant information specified in paragraph (1) on the packaging of the apparatus or in a document accompanying the apparatus where—

(a) due to the size or nature of the apparatus, it is not possible for the information in paragraph (1)(a) to appear on the apparatus; or

(b) it is not possible for the information in paragraphs (1)(b) or (1)(c) to appear on the apparatus.

(3) The postal address in paragraph (1)(c) must indicate a single point at which the manufacturer can be contacted.

(4) The information specified in paragraphs (1)(b) and (1)(c) must be in a language which can be easily understood by end-users and the competent national authority in the [F44 relevant state] in which it is to be made available to such end-users.

Textual Amendments

F44 Words in reg. 13(4) substituted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 8 para. 3(2)

Instructions and information E+W+S

[F14 14.   When placing apparatus on the market, a manufacturer must ensure that the apparatus is accompanied by instructions and the information referred to in regulation 36 (information concerning the use of apparatus) which are clear, legible and in clearly understandable English.]

Extent Information

E4 This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F14 Reg. 14 substituted (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. 11 (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Instructions and information N.I.

14.—(1) When placing apparatus on the market, a manufacturer must ensure that the apparatus is accompanied by instructions and the information referred to in regulation 36 (information concerning the use of apparatus) which—

(a) is in a language that can be easily understood by consumers and other end-users in the [F45 relevant state] in which the apparatus is to be made available; and

(b) is clear and understandable.

(2) When the apparatus is being made available to consumers and other end-users in [F46 Northern Ireland], the language referred to in paragraph (1)(a) is English.

Textual Amendments

F45 Words in reg. 14(1)(a) substituted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 8 para. 3(2)

F46 Words in reg. 14(2) substituted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 8 para. 3(3)

Manufacturer's duty to take action in respect of apparatus placed on the market which is considered not to be in conformity E+W+S

15.—(1) A manufacturer who considers, or has reason to believe, that apparatus which the manufacturer has placed on the market is not in conformity with Part 2 must immediately take the corrective measures necessary to—

(a) bring the apparatus into conformity;

(b) withdraw the apparatus; or

(c) recall the apparatus.

(2) Where the apparatus presents a risk, the manufacturer must immediately inform the market surveillance authority, F15 ... giving details of, in particular—

(a) the respect in which the apparatus is considered not to be in conformity with Part 2; and

(b) any corrective measures taken.

Extent Information

E5 This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F15 Words in reg. 15(2) omitted (E.W.S.) (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. 20 para. 12 (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Manufacturer's duty to take action in respect of apparatus placed on the market which is considered not to be in conformity N.I.

15.—(1) A manufacturer who considers, or has reason to believe, that apparatus which the manufacturer has placed on the market is not in conformity with Part 2 must immediately take the corrective measures necessary to—

(a) bring the apparatus into conformity;

(b) withdraw the apparatus; or

(c) recall the apparatus.

(2) Where the apparatus presents a risk, the manufacturer must immediately inform the market surveillance authority, and the competent national authorities of any other [F47 relevant state] in which the manufacturer has made the apparatus available on the market, giving details of, in particular—

(a) the respect in which the apparatus is considered not to be in conformity with Part 2; and

(b) any corrective measures taken.

Textual Amendments

F47 Words in reg. 15(2) substituted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 8 para. 3(2)

Provision of information and co-operation U.K.

16.—(1) A manufacturer must, when requested by an enforcing authority and within such period as the authority may specify, provide the authority with all of the information and documentation necessary to demonstrate the conformity of the apparatus with Part 2.

(2) A request made under paragraph (1) must be accompanied by the reasons for making the request.

(3) The information and documentation referred to in paragraph (1)—

(a) may be provided in paper or electronic form; and

(b) must be in a language that can be easily understood by the enforcing authority.

(4) The manufacturer must, at the request of the enforcing authority, co-operate with the authority on any action taken to—

(a) evaluate the apparatus in accordance with regulation 56 (evaluation of apparatus presenting a risk);

(b) eliminate the risks posed by apparatus that the manufacturer has placed on the market.

Importers U.K.

Prohibition on placing apparatus on the market which is not in conformity U.K.

17.  An importer must not place apparatus on the market unless it is in conformity with the essential requirements.

Requirements that must be satisfied before an importer places apparatus on the market E+W+S

18.—(1) Before placing apparatus on the market an importer must ensure that—

(a) a relevant conformity assessment has been carried out by the manufacturer;

(b) the manufacturer has drawn up the technical documentation;

(c) the apparatus—

(i) bears the [F16 UK] marking; and

(ii) is accompanied by the required documents; and

(d) the manufacturer has complied with the requirements of regulation 13 (information identifying manufacturer).

(2) In paragraph (1)(c)(ii) “required documents” means any documents that are required to be provided pursuant to regulation 13(2).

Extent Information

E6 This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F16 Word in reg. 18(1)(c)(i) 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. 13 (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Requirements that must be satisfied before an importer places apparatus on the market N.I.

18.—(1) Before placing apparatus on the market an importer must ensure that—

(a) a relevant conformity assessment has been carried out by the manufacturer;

(b) the manufacturer has drawn up the technical documentation;

(c) the apparatus—

(i) bears the CE marking; and

(ii) is accompanied by the required documents; and

(d) the manufacturer has complied with the requirements of regulation 13 (information identifying manufacturer).

(2) In paragraph (1)(c)(ii) “required documents” means any documents that are required to be provided pursuant to regulation 13(2).

Duty not to place non-conforming apparatus on the market U.K.

19.—(1) Where an importer considers or has reason to believe that apparatus is not in conformity with the essential requirements, the importer must not place the apparatus on the market.

(2) Where apparatus presents a risk, the importer must inform the manufacturer and the market surveillance authority of that risk.

Information identifying importer E+W+S

20.—(1) An importer must, before placing apparatus on the market, ensure that the following appear on the apparatus F17 ...—

(a) the name, registered trade name or registered trade mark of the importer; and

(b) a postal address at which the importer can be contacted.

[F18 (1A) Paragraph (1) does not apply where—

(a) either—

(i) it is not possible to set out the information referred to in paragraph (1) on the packaging of the apparatus or on the apparatus, or

(ii) the importer has imported the apparatus from an EEA state or Switzerland and places it on the market within the period of [F19 seven years] beginning with IP completion day, and

(b) before placing the apparatus on the market, the importer sets out the information referred to in paragraph (1) in a document accompanying the apparatus.]

(2) The information specified in paragraph (1) must be in a language which can be easily understood by end-users and the [F20 enforcing authority].

Extent Information

E7 This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F17 Words in reg. 20(1) omitted (E.W.S.) (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. 20 para. 14(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)

F18 Reg. 20(1A) 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. 20 para. 14(b) (with Sch. 20 para. 33) (as amended by: S.I. 2019/1246, regs. 1(3), 5, 6; S.I. 2020/676, regs. 1(1), 2; S.I. 2020/852, regs. 2(2), 4(2), Sch. 1 para. 1(i)(iii); and S.I. 2020/1460, reg. 1(4), Sch. 3 para. 2(1)(e)); 2020 c. 1, Sch. 5 para. 1(1)

F19 Words in reg. 20(1A)(a)(ii) substituted (E.W.S.) (31.12.2022) by The Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022 (S.I. 2022/1393), regs. 1(1), 4, Sch. 3 para. (g)

F20 Words in reg. 20(2) 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. 14(c) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Modifications etc. (not altering text)

C1 Reg. 20 modified (temp.) by S.I. 2019/392, reg. 6 (as inserted (10.9.2019) by The Product Safety, Metrology and Mutual Recognition Agreement (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1246), regs. 1(2)(4), 2(3) (with reg. 18))

Information identifying importer N.I.

20.—(1) An importer must, before placing apparatus on the market, ensure that the following appear on the apparatus or, where that is not possible, on the packaging of the apparatus or in a document accompanying the apparatus—

(a) the name, registered trade name or registered trade mark of the importer; and

(b) a postal address at which the importer can be contacted.

(2) The information specified in paragraph (1) must be in a language which can be easily understood by end-users and the competent national authority in the [F48 relevant state] in which it is to be made available.

Textual Amendments

F48 Words in reg. 20(2) substituted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 8 para. 3(2)

Instructions and information E+W+S

21.—(1) When placing apparatus on the market, an importer must ensure that the apparatus is accompanied by instructions and the information referred to in regulation 36 (information concerning the use of apparatus) which [F21 are clear, legible and in easily understandable English].

F22 (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E8 This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F21 Words in reg. 21(1) 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. 15(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)

F22 Reg. 21(2) omitted (E.W.S.) (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. 20 para. 15(b) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Instructions and information N.I.

21.—(1) When placing apparatus on the market, an importer must ensure that the apparatus is accompanied by instructions and the information referred to in regulation 36 (information concerning the use of apparatus) which is in a language which can be easily understood by consumers and other end-users in the [F49 relevant state] in which the apparatus is to be made available.

(2) When the apparatus is being made available to consumers and other end-users in [F50 Northern Ireland], the language referred to in paragraph (1) is English.

Textual Amendments

F49 Words in reg. 21(1) substituted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 8 para. 3(2)

F50 Words in reg. 21(2) substituted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 8 para. 3(3)

Storage and transport U.K.

22.  Where an importer has responsibility for apparatus, the importer must ensure that the conditions under which the apparatus is stored or transported do not jeopardise its conformity with the essential requirements.

Importer's duty to take action in respect of apparatus placed on the market which is considered not to be in conformity E+W+S

23.—(1) An importer who considers or has reason to believe that apparatus that the importer has placed on the market is not in conformity with Part 2 must immediately take the corrective measures necessary to—

(a) bring the apparatus into conformity;

(b) withdraw the apparatus; or

(c) recall the apparatus.

(2) Where the apparatus presents a risk, the importer must immediately inform the market surveillance authority F23 ... of the risk, giving details of—

(a) the respect in which the apparatus is considered not to be in conformity with Part 2; and

(b) any corrective measures taken.

Extent Information

E9 This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F23 Words in reg. 23(2) omitted (E.W.S.) (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. 20 para. 16 (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Importer's duty to take action in respect of apparatus placed on the market which is considered not to be in conformity N.I.

23.—(1) An importer who considers or has reason to believe that apparatus that the importer has placed on the market is not in conformity with Part 2 must immediately take the corrective measures necessary to—

(a) bring the apparatus into conformity;

(b) withdraw the apparatus; or

(c) recall the apparatus.

(2) Where the apparatus presents a risk, the importer must immediately inform the market surveillance authority and the competent authorities of any [F51 relevant state] in which the importer has made the apparatus available on the market of the risk, giving details of—

(a) the respect in which the apparatus is considered not to be in conformity with Part 2; and

(b) any corrective measures taken.

Textual Amendments

F51 Words in reg. 23(2) substituted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 8 para. 3(2)

Retention of technical documentation and [F24 EU] declaration of conformity U.K.

24.  An importer must keep the technical documentation and the [F25 EU] declaration of conformity (as referred to in regulation 41) drawn up in respect of the apparatus for a period of 10 years beginning on the day on which the apparatus is placed on the market.

Textual Amendments

F24 Word in reg. 24 heading omitted (E.W.S.) (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. 20 para. 17 (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F25 Word in reg. 24 omitted (E.W.S.) (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. 20 para. 17 (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Provision of information and co-operation U.K.

25.—(1) An importer must, when requested by an enforcing authority and within such period as the authority may specify, provide the authority with all of the information and documentation necessary to demonstrate the conformity of the apparatus with Part 2.

(2) A request made under paragraph (1) must be accompanied by the reasons for making the request.

(3) The information and documentation referred to in paragraph (1) —

(a) may be provided in paper or electronic form; and

(b) must be in a language that can be easily understood by the enforcing authority.

(4) An importer must, at the request of the enforcing authority, co-operate with the authority on any action taken to—

(a) evaluate the apparatus in accordance with regulation 56 (evaluation of apparatus presenting a risk); and

(b) eliminate the risks posed by apparatus that importer has placed on the market.

Distributors U.K.

Duty to act with due care U.K.

26.  When making apparatus available on the market, a distributor must act with due care to ensure that it is in conformity with Part 2.

Making available on the market E+W+S

27.—(1) Before making apparatus available on the market, a distributor must verify that—

(a) the apparatus—

(i) bears the [F26 UK] marking;

(ii) is accompanied by the required documents;

(iii) is accompanied by instructions and the information referred to in regulation 36 (information concerning the use of apparatus) which [F27 are clear, legible and in easily understandable English];

(b) the manufacturer has complied with the requirements of regulation 13 (information identifying manufacturer); and

(c) the importer has complied with the requirements of regulation 20 (information identifying importer).

(2) In paragraph (1)(a)(ii) “required documents” means any documents that are required to be provided pursuant to regulation 13(2).

Extent Information

E10 This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F26 Word in reg. 27(1)(a)(i) 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. 18(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)

F27 Words in reg. 27(1)(a)(iii) 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. 18(b) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Making available on the market N.I.

27.—(1) Before making apparatus available on the market, a distributor must verify that—

(a) the apparatus—

(i) bears the CE marking;

(ii) is accompanied by the required documents;

(iii) is accompanied by instructions and the information referred to in regulation 36 (information concerning the use of apparatus) which is in a language which can be easily understood by consumers and other end-users in the [F52 relevant state] in which the apparatus is to be made available on the market;

(b) the manufacturer has complied with the requirements of regulation 13 (information identifying manufacturer); and

(c) the importer has complied with the requirements of regulation 20 (information identifying importer).

(2) In paragraph (1)(a)(ii) “required documents” means any documents that are required to be provided pursuant to regulation 13(2).

Textual Amendments

F52 Words in reg. 27(1)(a)(iii) substituted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 8 para. 3(2)

Duty not to make non-conforming apparatus available on the market U.K.

28.—(1) Where a distributor considers or has reason to believe that apparatus is not in conformity with the essential requirements, the distributor must not make the apparatus available on the market.

(2) Where apparatus presents a risk, the distributor must inform the manufacturer and the market surveillance authority of that risk.

Storage and transport U.K.

29.  Where a distributor has responsibility for apparatus, the distributor must ensure that the conditions under which the apparatus is stored or transported do not jeopardise its conformity with the essential requirements.

Duty to take action in respect of apparatus placed on the market or made available on the market which is considered not to be in conformity E+W+S

30.—(1) A distributor who considers or has reason to believe that apparatus that the distributor has made available on the market is not in conformity with Part 2 must immediately take the corrective measures necessary to—

(a) bring the apparatus into conformity;

(b) to withdraw the apparatus; or

(c) recall the apparatus.

(2) Where the apparatus presents a risk, the distributor must immediately inform the market surveillance authority F28 ... of the risk, giving details of—

(a) the respect in which the apparatus is not considered to be in conformity with Part 2; and

(b) any corrective measures taken.

Extent Information

E11 This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F28 Words in reg. 30(2) omitted (E.W.S.) (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. 20 para. 19 (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Duty to take action in respect of apparatus placed on the market or made available on the market which is considered not to be in conformity N.I.

30.—(1) A distributor who considers or has reason to believe that apparatus that the distributor has made available on the market is not in conformity with Part 2 must immediately take the corrective measures necessary to—

(a) bring the apparatus into conformity;

(b) to withdraw the apparatus; or

(c) recall the apparatus.

(2) Where the apparatus presents a risk, the distributor must immediately inform the market surveillance authority and the competent authorities of any other [F53 relevant state] in which the distributor has made the apparatus available on the market of the risk, giving details of—

(a) the respect in which the apparatus is not considered to be in conformity with Part 2; and

(b) any corrective measures taken.

Textual Amendments

F53 Words in reg. 30(2) substituted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 8 para. 3(2)

Provision of information and co-operation E+W+S

31.—(1) A distributor must, when requested by an enforcing authority and within such period as the authority may specify, provide the authority with all of the information and documentation necessary to demonstrate the conformity of the apparatus with Part 2.

(2) A request referred to in paragraph (1) must be accompanied by the reasons for making the request.

(3) The information and documentation referred to in paragraph (1) —

(a) may be provided in paper or electronic form; and

(b) must be [F29 clear, legible and in easily understandable English].

(4) A distributor must, at the request of the enforcing authority, co-operate with the authority on any action taken to—

(a) evaluate the apparatus in accordance with regulation 56 (evaluation of apparatus presenting a risk); and

(b) eliminate the risks posed by apparatus that they have made available on the market.

Extent Information

E12 This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F29 Words in reg. 31(3)(b) 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. 20 (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Provision of information and co-operation N.I.

31.—(1) A distributor must, when requested by an enforcing authority and within such period as the authority may specify, provide the authority with all of the information and documentation necessary to demonstrate the conformity of the apparatus with Part 2.

(2) A request referred to in paragraph (1) must be accompanied by the reasons for making the request.

(3) The information and documentation referred to in paragraph (1) —

(a) may be provided in paper or electronic form; and

(b) must be in a language that can be easily understood by the enforcing authority.

(4) A distributor must, at the request of the enforcing authority, co-operate with the authority on any action taken to—

(a) evaluate the apparatus in accordance with regulation 56 (evaluation of apparatus presenting a risk); and

(b) eliminate the risks posed by apparatus that they have made available on the market.

All economic operators U.K.

Cases in which the obligations of manufacturers apply to importers and distributors U.K.

32.  An economic operator (“A”) who would, but for this regulation, be considered an importer or distributor, is to be considered a manufacturer for the purposes of these Regulations and is subject to the obligations of a manufacturer under Part 2, where A—

(a) places apparatus on the market under A's own name or trademark; or

(b) modifies apparatus already placed on the market in such a way that it may affect whether the apparatus is in conformity with Part 2.

Identification of economic operators U.K.

33.—(1) An economic operator (“E”), who receives a request in relation to apparatus from the market surveillance authority before the end of the relevant period, must, within such period as the authority may specify, identify to the authority—

(a) any other economic operator who has supplied E with apparatus; and

(b) any other economic operator to whom E has supplied apparatus.

(2) The relevant period is—

(a) in the case of paragraph (1)(a), the period of 10 years beginning on the day on which E was supplied with the apparatus;

(b) in the case of paragraph (1)(b), the period of 10 years beginning on the day on which E supplied the apparatus.

Translation of EU declaration of conformity U.K.

34.— [F30 (1) Before placing apparatus on the market or making apparatus available on the market, an economic operator must ensure that the EU declaration of conformity is prepared in, or translated into, the language required by the [F31 relevant state] in which it is to be placed on the market or made available on the market.

(2) Where the apparatus is to be placed on the market or made available on the market in [F32 Northern Ireland], the language referred to in paragraph (1) is English.]

Textual Amendments

F30 Reg. 34 omitted (E.W.S.) (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. 20 para. 21 (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F31 Words in reg. 34(1) substituted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 8 para. 3(2)

F32 Words in reg. 34(2) substituted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 8 para. 3(3)

Prohibition on improper use of [F33 UK] marking E+W+S

35.—(1) An economic operator must not affix the [F34 UK] marking to apparatus unless—

(a) that economic operator is the manufacturer of the apparatus; and

(b) the conformity of apparatus with the essential requirements has been demonstrated by a relevant conformity procedure.

(2) An economic operator must not affix a marking (other than [F34 UK] marking) to equipment which purports to attest to the conformity of the equipment with the essential requirements.

(3) An economic operator must not affix to equipment a marking, sign or inscription which is likely to mislead any other person as to the meaning or form of the [F34 UK] marking.

(4) An economic operator must not affix to equipment any other marking if the visibility, legibility and meaning of the [F34 UK] marking would be impaired as a result.

Extent Information

E13 This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F33 Word in reg. 35 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. 22 (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F34 Word in reg. 35 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. 22 (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Prohibition on improper use of CE marking N.I.

35.—(1) An economic operator must not affix the CE marking to apparatus unless—

(a) that economic operator is the manufacturer of the apparatus; and

(b) the conformity of apparatus with the essential requirements has been demonstrated by a relevant conformity procedure.

(2) An economic operator must not affix a marking (other than CE marking) to equipment which purports to attest to the conformity of the equipment with the essential requirements.

(3) An economic operator must not affix to equipment a marking, sign or inscription which is likely to mislead any other person as to the meaning or form of the CE marking.

(4) An economic operator must not affix to equipment any other marking if the visibility, legibility and meaning of the CE marking would be impaired as a result.

Information concerning the use of apparatus U.K.

36.—(1) A person who places apparatus on the market must provide with the apparatus—

(a) information on any specific precautions which must be taken during assembly, installation, maintenance or use to ensure that the apparatus will be in conformity with the requirements of paragraph 1 of Schedule 1 when it is put into service;

(b) information on the restrictions on the use of the apparatus in residential areas where the conformity of the apparatus with paragraph 1 of Schedule 1 cannot be ensured; and

(c) information required to enable the apparatus to be used in accordance with its intended purpose.

(2) Where appropriate, the information referred to in paragraph (1)(b) must also be included on the packaging of the apparatus.

Fixed installations U.K.

37.—(1) Subject to paragraph (2), apparatus that has been made available on the market and which can be incorporated into a fixed installation is subject to all of the relevant provisions for apparatus in these Regulations.

(2) Where apparatus is intended for incorporation into a particular fixed installation and is not otherwise made available on the market, the requirements of Part 2 and Part 3 do not apply.

(3) A person who places apparatus of the type referred to in paragraph (2) on the market must provide information with the apparatus which—

(a) identifies the fixed installation in which it is to be incorporated and the electromagnetic compatibility characteristics of that fixed installation;

(b) sets out the precautions to be taken when the apparatus is incorporated into the fixed installation to ensure the conformity of the installation with Part 2;

(c) includes the information referred to in—

(i) regulation 13 (information identifying manufacturer); and

(ii) if relevant, regulation 20 (information identifying importer).

(4) The good engineering practices referred to in paragraph 2 of Schedule 1 must be documented and the documentation held by the person who installed the fixed installation during the period of operation of the fixed installation.

(5) The person referred to in paragraph (4) must ensure that the documentation can be made available to the relevant national authorities upon request during the period of operation of that fixed installation.

(6) Where the enforcing authority has received complaints about disturbances being generated by the fixed installation or has reason to believe that a fixed installation may not be in conformity with these Regulations, the enforcing authority may request evidence of conformity of the fixed installation and may initiate an evaluation of the fixed installation.

(7) Where the enforcing authority considers that the evaluation referred to in paragraph (6) has established that the fixed installation is not in conformity with these Regulations, the enforcing authority must ensure that appropriate measures are taken to ensure that the fixed installation is brought into conformity with the essential requirements in Schedule 1.

(8) The person referred to in paragraph (4) is responsible for ensuring that the installation is in conformity with the relevant essential requirements.

Authorised representatives U.K.

Appointment of an authorised representative E+W+S

38.—(1) A manufacturer may, by written mandate, appoint a person [F35 established in the United Kingdom] as their authorised representative to perform specified tasks on the manufacturer's behalf.

(2) The mandate must allow the authorised representative to do at least the following in relation to apparatus covered by the mandate—

(a) perform the manufacturer's obligations under regulation 11 (retention of technical documentation and F36 ... declaration of conformity);

(b) perform the manufacturer's obligations under regulation 16 (provision of information and co-operation).

(3) The mandate must not include the obligations contained in—

(a) regulation 8 (duty to ensure apparatus complies with the essential requirements); or

(b) regulation 9 (technical documentation and conformity assessment).

(4) A manufacturer who has appointed an authorised representative to perform, on the manufacturer's behalf, a task under these Regulations remains responsible for the proper performance of that task.

(5) An authorised representative must comply with all the duties imposed on the manufacturer in relation to each obligation under these Regulations that the representative is appointed by the mandate to perform and accordingly—

(a) as far as those duties are concerned, a reference in these Regulations to the manufacturer (except in this regulation) is to be taken as including a reference to the authorised representative; and

(b) if the authorised representative contravenes or fails to comply with any of those duties, the authorised representative may be proceeded against as though the authorised representative were the manufacturer.

Extent Information

E14 This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F35 Words in reg. 38(1) 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. 20 para. 23(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)

F36 Word in reg. 38(2)(a) omitted (E.W.S.) (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. 20 para. 23(b) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Appointment of an authorised representative N.I.

38.—(1) A manufacturer may, by written mandate, appoint a person as their authorised representative to perform specified tasks on the manufacturer's behalf.

(2) The mandate must allow the authorised representative to do at least the following in relation to apparatus covered by the mandate—

(a) perform the manufacturer's obligations under regulation 11 (retention of technical documentation and EU declaration of conformity);

(b) perform the manufacturer's obligations under regulation 16 (provision of information and co-operation).

(3) The mandate must not include the obligations contained in—

(a) regulation 8 (duty to ensure apparatus complies with the essential requirements); or

(b) regulation 9 (technical documentation and conformity assessment).

(4) A manufacturer who has appointed an authorised representative to perform, on the manufacturer's behalf, a task under these Regulations remains responsible for the proper performance of that task.

(5) An authorised representative must comply with all the duties imposed on the manufacturer in relation to each obligation under these Regulations that the representative is appointed by the mandate to perform and accordingly—

(a) as far as those duties are concerned, a reference in these Regulations to the manufacturer (except in this regulation) is to be taken as including a reference to the authorised representative; and

(b) if the authorised representative contravenes or fails to comply with any of those duties, the authorised representative may be proceeded against as though the authorised representative were the manufacturer.

[F37 Obligations which are met by complying with obligations in the Directive E+W+S

38A.— (1) In this regulation—

(a) any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive;

(b) “CE marking” has the meaning given to it in Article 3(25);

(c) “harmonised standard” has the meaning given to it in Article 3(17).

(2) Paragraph (3) applies where, before placing apparatus on the market, the manufacturer—

(a) ensures that the apparatus has been designed and manufactured in accordance with the essential requirements set out in Annex I;

(b) draws up the technical documentation relating to such apparatus referred to in Annex III;

(c) ensures that the relevant conformity assessment procedure relating to such apparatus referred to in Article 14 has been carried out;

(d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedure are prepared in or translated into English;

(e) affixes a CE marking, in accordance with Articles 16 and 17(1) to (2);

(f) draws up an EU declaration of conformity, in accordance with Article 15; and

(g) ensures that the EU declaration of conformity is prepared in or translated into English.

(3) Where this paragraph applies—

(a) the requirements of regulations 8, 9, 10(1)(a) and (b) and (3) and 42(1) are to be treated as being satisfied;

(b) regulations 2(2)(a), 10(2), 11, 12, 38(2) and 35 apply subject to the modifications in paragraph (8);

(c) [F38 Part 3] does not apply; and

(d) regulation 59 does not apply.

(4) Paragraph (5) applies where, before placing a category apparatus on the market, the importer ensures that—

(a) the relevant conformity assessment procedure referred to in Article 14 has been carried out;

(b) the manufacturer has drawn up the technical documentation referred to in Annex III; and

(c) the apparatus bears the CE marking.

(5) Where this paragraph applies—

(a) the requirements of regulation 18(a) to (c) are to be treated as being satisfied; and

(b) regulations 2(2)(a), 17, 19(1), 22 and 24 apply subject to the modifications in paragraph (8).

(6) Paragraph (7) applies where, before making apparatus available on the market, a distributor ensures that the apparatus bears the CE marking.

(7) Where this paragraph applies—

(a) regulation 27(1)(a) is to be treated as being satisfied; and

(b) regulations 2(2)(a), 28(1) and 29 apply subject to the modifications in paragraph (10).

(8) The modifications referred to in sub-paragraphs (3)(b), (5)(b) and (9)(b) are that—

(a) any reference to “declaration of conformity” is to be read as a reference to the EU declaration of conformity;

(b) any reference to “UK marking” is to be read as a reference to the CE marking;

(c) any reference to “essential requirements” is to be read as a reference to the essential F39 ... requirements referred to in Annex I;

(d) any reference to “designated standard” is to be read as a reference to a harmonised standard;

(e) any reference to “relevant conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedures referred to in Article 14;

(f) any reference to “technical documentation” is a reference to the technical documentation referred to in Annex III.

Textual Amendments

F37 Regs. 38A-38C 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. 20 para. 24 (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2 and S.I. 2020/1460, reg. 1(4), Sch. 3 para. 12(3)); 2020 c. 1, Sch. 5 para. 1(1)

F38 Words in reg. 38A(3)(c) substituted (1.10.2024) by The Product Safety and Metrology etc. (Amendment) Regulations 2024 (S.I. 2024/696), regs. 1(2), 11(3)(a) (with reg. 23)

F39 Word in reg. 38A(8)(c) omitted (1.10.2024) by virtue of The Product Safety and Metrology etc. (Amendment) Regulations 2024 (S.I. 2024/696), regs. 1(2), 11(3)(b) (with reg. 23)

[F40 Further use of the UK marking E+W+S

38B.— (1) In this regulation—

(a) any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive;

(b) “harmonised standard” has the meaning given to it in Article 3(17).

(2) Paragraph (3) applies where, before placing apparatus on the market, the manufacturer—

(a) ensures that the apparatus has been designed and manufactured in accordance with the essential requirements set out in Annex I;

(b) draws up the technical documentation relating to such apparatus referred to in Annex III;

(c) ensures that the relevant conformity assessment procedure relating to such apparatus referred to in Article 14 has been carried out; and

(d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedure are prepared in or translated into English.

(3) Where this paragraph applies—

(a) the requirements of regulations 8 and 9 are to be treated as being satisfied;

(b) except for regulations 41 and 42, Part 3 does not apply;

(c) regulations 2(2)(a), 7, 11, 12, 17 to 19, 22, 24, 28, 29, 35(1), 41 and 59 apply subject to the modifications in paragraph (4);

(d) regulation 10 and Schedule 4 apply subject to the modifications in paragraphs (4) and (5);

(e) regulations 36 and 37 apply subject to the modifications in paragraph (6).

(4) The modifications referred to in paragraph (3)(c) and (d) are that—

(a) any reference to “essential requirements” is to be read as a reference to the essential requirements set out in Annex 1;

(b) any reference to “designated standard” is to be read as a reference to “harmonised standard”;

(c) any reference to “relevant conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedure referred to in Article 14;

(d) any reference to “technical documentation” is to be read as a reference to the technical documentation referred to in Annex III.

(5) The modifications referred to in paragraph (3)(d) are that—

(a) in regulation 10, the reference to “enactment” is to be read as including the Directive;

(b) in Schedule 4—

(i) in paragraph 5, the reference to “statutory requirements” is to be read as including the Directive;

(ii) in paragraph 7, the reference to “approved body” is to be read as a reference to the conformity assessment body that undertook any conformity assessment procedure in accordance with Article 14.

(6) The modifications referred to in paragraph (3)(e) are that—

(a) in regulation 36 any reference to “paragraph 1 of Schedule 1” is to be read as a reference to paragraph 1 of Annex I;

(b) in regulation 37 any reference to “paragraph 2 of Schedule 1” is to be read as a reference to paragraph 2 of Annex I.]

Textual Amendments

F37 Regs. 38A-38C 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. 20 para. 24 (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2 and S.I. 2020/1460, reg. 1(4), Sch. 3 para. 12(3)); 2020 c. 1, Sch. 5 para. 1(1)

F40 Reg. 38B substituted (1.10.2024) by The Product Safety and Metrology etc. (Amendment) Regulations 2024 (S.I. 2024/696), regs. 1(2), 11(4) (with reg. 23)

Qualifying Northern Ireland Goods E+W+S

38C.— (1) Where paragraph (2) applies, apparatus is to be treated as being in conformity with Part 2.

(2) This paragraph applies where—

(a) apparatus—

(i) is in conformity with Part 2, as that Part applies in Northern Ireland; and

(ii) is qualifying Northern Ireland goods; and

(b) an importer has complied with the obligations set out in paragraph (3).

(3) The obligations referred to in paragraph (2)(b) are that, before placing the apparatus on the market, the importer—

(a) complies with regulation 20;

(b) ensures that—

(i) the relevant conformity assessment procedure has been carried out in relation to the apparatus;

(ii) the manufacturer has drawn up the technical documentation; and

(iii) the apparatus bears the CE marking.

(4) In this regulation—

“CE marking” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland;

“qualifying Northern Ireland goods” has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018;

“relevant conformity assessment procedure” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland;

“technical documentation” means the documentation a manufacturer must draw up, in accordance with regulation 9(b), as it applies in Northern Ireland.]

Textual Amendments

F37 Regs. 38A-38C 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. 20 para. 24 (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2 and S.I. 2020/1460, reg. 1(4), Sch. 3 para. 12(3)); 2020 c. 1, Sch. 5 para. 1(1)