8. Before placing apparatus on the market, a manufacturer must ensure that it has been designed and manufactured in accordance with the essential requirements.
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: [F1EU-]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
F1Word 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)
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 [F4a] declaration of conformity in accordance with regulation 41 F5...; and
(b)affix the [F6UK] marking in accordance with regulation 42 ([F6UK] 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
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 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)
F3Word 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)
F4Word 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)
F5Words 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)
F6Word 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)
F7Word 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)
F8Reg. 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)
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 [F16NI 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 [F17relevant] EU instruments; and
(b)includes references to the publication of [F18the relevant EU] instruments in the Official Journal.
Textual Amendments
F16Words 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)
F17Word 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)
F18Words 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)
11. A manufacturer must keep the technical documentation and the [F10EU] 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
F9Word 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)
F10Word 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)
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 [F11designated] standard or in another technical specification by reference to which the F12... declaration of conformity was drawn up.
Extent Information
E2This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F11Word 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)
F12Word 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)
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.
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 [F13clear, legible and in easily understandable English].
Extent Information
E3This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F13Words 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)
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 [F19relevant state] in which it is to be made available to such end-users.
Textual Amendments
F19Words 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)
[F1414. 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
E4This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F14Reg. 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)
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 [F20relevant 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 [F21Northern Ireland], the language referred to in paragraph (1)(a) is English.
Textual Amendments
F20Words 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)
F21Words 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)
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
E5This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F15Words 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)
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 [F22relevant 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
F22Words 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)
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.