CHAPTER 1 — OBLIGATIONS OF MANUFACTURERS AND PERSONS TO BE TREATED AS MANUFACTURERS
Introductory
(1) This Chapter applies in relation to the placing on the market or the putting into use of a regulated measuring instrument by a manufacturer.
(2) The obligations in this Chapter also apply to an importer or distributor who—
(a) places a regulated measuring instrument on the market under the name or trade mark of that importer or distributor; or
(b) modifies a regulated measuring instrument already placed on the market in such a way that compliance with these Regulations may be affected,
and the expression “ manufacturer ” is to be construed accordingly.
Manufacturers' responsibilities – design, conformity assessment and marking of regulated measuring instruments
(1) A manufacturer must not place on the market or put into use a regulated measuring instrument unless the manufacturer has—
(a) designed and manufactured the instrument in accordance with the essential requirements;
(b) drawn up technical documentation in relation to the instrument;
(c) carried out (or procured the carrying out of) the relevant conformity assessment procedure which has demonstrated compliance of the instrument with the applicable requirements;
(d) drawn up a declaration of conformity; and
(e) affixed to the instrument or where paragraph (2) applies in respect of the UK marking, to a label affixed to a product or to a document accompanying the product —
(i) the UK marking; and
(ii) the M marking.
(2) For a period of seven years beginning with IP completion day, the UK marking may be affixed to—
(a) a label affixed to the instrument; or
(b) to a document accompanying the instrument.
Manufacturers – obligations in respect of records
A manufacturer must keep the technical documentation and the EU declaration of conformity for a period of 10 years beginning with the day after the day on which the regulated measuring instrument to which it relates has been placed on the market.
Manufacturers' obligations to ensure continuing conformity with essential requirements
(1) Manufacturers must have procedures in place for series production of regulated measuring instruments by them to ensure that instruments so manufactured continue to meet the essential requirements.
(2) The procedures mentioned in paragraph (1) must adequately take into account changes in—
(a) measuring instrument design or characteristics; and
(b) changes in the designated standards, normative documents or in other technical specifications by reference to which the conformity of the regulated measuring instrument is declared.
(3) When deemed appropriate with regard to the performance of a regulated measuring instrument, manufacturers must—
(a) carry out sample testing of regulated measuring instruments manufactured by them made available on the market;
(b) investigate complaints about regulated measuring instruments manufactured by them;
(c) if necessary, keep a register of—
(i) such complaints;
(ii) non-conforming measuring instruments; and
(iii) measuring instrument recalls; and
(d) keep distributors informed of any monitoring undertaken by them.
Manufacturers' obligations in relation to the marking of regulated measuring instruments with serial numbers etc.
(1) A manufacturer must ensure that a regulated measuring instrument, which that manufacturer has placed on the market, bears a type, batch or serial number or other element allowing identification of that instrument.
(2) Paragraph (1) does not apply where the dimensions of the regulated measuring instrument are too small or it is of too sensitive a composition to allow it to bear the information required by that paragraph and in such a case the information must be marked on the instrument's packaging (if any) and the accompanying documents required by these Regulations.
Manufacturers to mark contact details on regulated measuring instruments where possible
(1) A manufacturer must indicate on every regulated measuring instrument manufactured by that manufacturer, the manufacturer's name, registered trade name or registered trade mark and the postal address at which the manufacturer can be contacted.
(2) Paragraph (1) does not apply where the dimensions of the regulated measuring instrument are too small or it is of too sensitive a composition to allow it to bear the information required by that paragraph and in such a case the information must be marked on the instrument's packaging (if any) and the accompanying documents required by these Regulations.
(3) The address required by this regulation must indicate a single point at which the manufacturer can be contacted.
(4) The contact details required by this regulation must be clear, legible and in easily understandable English.
Documentation to accompany regulated measuring instruments
(1) A manufacturer must ensure that regulated measuring instruments that the manufacturer has placed on the market are accompanied by—
(a) a copy of the ... declaration of conformity relating to the instruments;
(b) information on the operation of the instruments including, where relevant, the following—
(i) rated operating conditions;
(ii) mechanical and electromagnetic environment classes;
(iii) the upper and lower temperature limit, whether condensation is possible or not, open or closed location;
(iv) instructions for installation, maintenance, repairs, permissible adjustments;
(v) instructions for correct operation and any special conditions of use; and
(vi) conditions for compatibility with interfaces, sub-assemblies or measuring instruments.
(2) Paragraph (1) (b) does not apply where the simplicity of the regulated measuring instrument makes the supply of the information referred to in that paragraph unnecessary.
(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(4) Such instructions and information (and any labelling) relating to a regulated measuring instrument must be clear, legible and in easily understandable English .
Action to be taken where regulated measuring instruments placed on the market are not in conformity with the essential requirements
(1) This regulation applies where a manufacturer considers or has reason to believe that a regulated measuring instrument placed on the market by that manufacturer is not in conformity with the requirements of these Regulations.
(2) The manufacturer must immediately take the corrective measures necessary to bring the regulated measuring instrument into conformity or withdraw or recall it, if appropriate.
(3) Where the regulated measuring instrument presents a risk, the manufacturer must immediately inform the competent authority to that effect giving details, in particular, of the non-compliance and of any corrective measures taken.
Provision of information to the competent authority
(1) A manufacturer must, further to a reasoned request from a competent authority, provide the competent authority with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of a regulated measuring instrument manufactured by it with the requirements of these Regulations.
(2) Information and documentation supplied to a competent authority pursuant to this regulation must be supplied in English.
(3) A manufacturer must co-operate with a competent authority, at the request of that authority, on any action to eliminate the risks posed by regulated measuring instruments that the manufacturer has placed on the market.
Use of authorised representatives by manufacturers
(1) A manufacturer may, by a written mandate, appoint a person established in the United Kingdom as their authorised representative to discharge the responsibilities under these Regulations in relation to the placing on the market of a regulated measuring instrument.
(2) A representative appointed under paragraph (1) may not discharge the manufacturer's obligations under regulation 7(a) and 7(b).
(3) An authorised representative shall be treated as being authorised to—
(a) keep the ... declaration of conformity and the technical documentation at the disposal of the market surveillance authority for 10 years beginning with the day after the day the regulated measuring instrument has been placed on the market;
(b) provide a competent authority, further to a reasoned request from that authority, with all the information and documentation necessary to demonstrate the conformity of a regulated measuring instrument; and
(c) cooperate with a competent authority, at its request on any action taken to eliminate the risks posed by regulated measuring instruments covered by its mandate.
CHAPTER 2 — OBLIGATIONS OF IMPORTERS
Introductory
This Chapter applies to the placing on the market or the putting into use of a regulated measuring instrument from a country outside the ... United Kingdom.
Ensuring compliance of regulated measuring instruments
(1) An importer must only place compliant regulated measuring instruments on the market.
(2) An importer must ensure that—
(a) the appropriate conformity assessment procedure has been carried out by the manufacturer of the regulated measuring instrument (or by the importer where the importer is to be regarded as the manufacturer by virtue of regulation 6(2));
(b) the manufacturer has drawn up the technical documentation (or that the importer has done so where the importer is treated as the manufacturer by virtue of regulation 6(2));
(c) the regulated measuring instrument bears the UK marking and the M marking;
(d) the regulated measuring instrument is accompanied by a copy of the ... declaration of conformity and the documents referred to in regulation 12 (documentation to accompany regulated measuring instruments); and
(e) the manufacturer (or the importer where he is treated as the manufacturer) has complied with the requirements of regulations 10 (manufacturers' obligations in relation to the marking of regulated measuring instruments with serial numbers etc.) and 11 (manufacturers to mark contact details on regulated measuring instruments where possible).
Importers duty to notify manufacturer and market surveillance authorities of non-compliant regulated measuring instruments that present a risk
Where an importer considers or has reason to believe that the regulated measuring instrument is not in conformity with the essential requirements and presents a risk, the importer must inform the manufacturer and the market surveillance authority.
Requirements to mark importers' details on regulated measuring instruments
(1) An importer must indicate on regulated measuring instruments imported by that importer, the importer's name, registered trade name or trademark and the postal address at which the importer can be contacted.
(2) Paragraph (1) does not apply where—
(a) either—
(i) the regulated measuring instrument it too small or too sensitive a composition to allow it to bear the information required by paragraph (1); or
(ii) the importer has imported the regulated measuring instrument from an EEA state or Switzerland and places it on the market within the period of seven years beginning with IP completion day, and
(b) before placing the regulated measuring instrument on the market, the importer sets out the information referred to in paragraph (1)—
(i) where sub-paragraph (a)(i) applies, on any packaging in which the instrument is supplied and in any accompanying documents;
(ii) where sub-paragraph (a)(ii) applies, in a document accompanying the instrument.
(3) Any contact details required by this regulation must be clear, legible and in easily understandable English.
Importers' duty to ensure that regulated measuring instruments are accompanied by relevant documentation
(1) An importer must ensure that regulated measuring instruments imported by that importer are, where relevant, accompanied by the following instructions and information ...—
(a) rated operating conditions;
(b) mechanical and electromagnetic environment classes;
(c) the upper and lower temperature limit, whether condensation is possible or not, open or closed location;
(d) instructions for installation maintenance, repairs, permissible adjustments;
(e) instructions for correct operation and any special conditions of use; and
(f) conditions for compatibility with interfaces, sub-assemblies or measuring instruments.
(2) The instructions and information referred to in paragraph (1) must be clear, legible and in easily understandable English.
Duty of importers to ensure proper conditions of storage and transport
An importer must, in respect of regulated measuring instruments under the importer's responsibility ensure that the conditions of their storage or transport are not such as to jeopardise their continuing compliance with the essential requirements.
Duties of importers with regard to monitoring etc.
(1) When deemed appropriate with regard to the performance of a regulated measuring instrument imported by an importer, the importer must—
(a) carry out a sample testing of regulated measuring instruments made available on the market by the importer;
(b) investigate complaints about regulated measuring instruments imported by the importer ; and
(c) if necessary, keep a register of—
(i) such complaints;
(ii) non-conforming regulated measuring instruments; and
(iii) regulated measuring instrument recalls; and
(d) where the importer is not also the distributor of the regulated measuring instrument, keep distributors to whom the importer has supplied regulated measuring instruments informed of any monitoring undertaken by that importer.
Action to be taken by importers where regulated measuring instruments placed on the market by them are not in conformity with essential requirements
(1) This regulation applies where an importer considers, or has reason to believe, that a regulated measuring instrument placed on the market by the importer is not in conformity with the requirements of these Regulations.
(2) The importer must immediately take the corrective measures necessary to bring the regulated measuring instrument into conformity or withdraw or recall it, if appropriate.
(3) Where the regulated measuring instrument presents a risk, the importer must immediately inform the competent authority to that effect, giving details, in particular, of the non-compliance of the instrument and of the corrective measures taken by that importer.
Requirement for importer to keep copy of EU declaration of conformity
An importer must, for a period of 10 years beginning with the day after the day on which the regulated measuring instrument is placed on the market, keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities upon request.
Provision of information to the competent authority
(1) The importer must, further to a reasoned request from a competent authority, provide the competent authority with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the regulated measuring instrument with the requirements of these Regulations.
(2) Information and documentation supplied to a competent authority pursuant to this regulation must be supplied in English.
(3) An importer must co-operate with a competent authority, at its request, as regards any action to eliminate the risks posed by any regulated measuring instrument that the importer has placed on the market.
CHAPTER 3 — OBLIGATIONS OF DISTRIBUTORS
Introductory
This Chapter applies in relation to the making available on the market or the putting into use of a regulated measuring instrument by a distributor.
Distributors – duty to act with due care
Before making the regulated measuring instrument available on the market or putting it into use, the distributor must act with due care in relation to the requirements of these Regulations.
Distributors – verification obligations
(1) The distributor must verify that the regulated measuring instrument bears the UK marking and the M marking.
(2) The distributor must verify that the regulated measuring instrument is accompanied by—
(a) a copy of the ... declaration of conformity relating to it; and
(b) information on the operation of the instrument including where relevant the following—
(i) rated operating conditions;
(ii) mechanical and electromagnetic environment classes;
(iii) the upper and lower temperature limit, whether condensation is possible or not, open and closed location
(iv) instructions for installation, maintenance, repairs, permissible adjustments;
(v) instructions for correct operation and any special conditions of use; and
(vi) conditions for compatibility with interfaces, sub-assemblies or measuring instruments.
(3) Paragraph (2) (b) does not apply where the simplicity of the regulated measuring instrument makes the supply of the information referred to in that paragraph unnecessary.
(4) Instructions and information supplied in accordance with this regulation must be clear, legible and in easily understandable English.
(5) The distributor must verify that the manufacturer and the importer have complied with the requirements set out in regulation 10 (manufacturers' obligations in relation to the marking of regulated measuring instruments with serial numbers etc.), regulation 11 (manufacturers to mark contact details on regulated measuring instruments where possible) and regulation 19 (requirements to mark importers' details on regulated measuring instruments).
Distributors not to make non-conforming regulated measuring instruments available on the market etc.
(1) This regulation applies where a distributor considers, or has reason to believe, that a regulated measuring instrument is not in conformity with the essential requirements.
(2) Where this regulation applies, the distributor must not make the regulated measuring instrument available on the market or put it into use until it has been brought into conformity.
(3) Where the regulated measuring instrument presents a risk, the distributor must immediately inform—
(a) the manufacturer;
(b) the importer (where the distributor is not also the manufacturer or importer); and
(c) the market surveillance authorities,
to that effect, giving details, in particular, of the non-compliance of the instrument and of the corrective measures taken by that distributor.
Duty of distributors to ensure proper conditions of storage and transport
A distributor must, in respect of regulated measuring instruments under that distributor's responsibility, ensure that the conditions of their storage or transport are not such as to jeopardise their continuing compliance with the essential requirements.
Action to be taken by distributors where regulated measuring instruments placed on the market by them are not in conformity with essential requirements
(1) This regulation applies where a distributor considers, or has reason to believe, that a regulated measuring instrument made available on the market or put into use by that distributor is not in conformity with the requirements of these Regulations.
(2) The distributor must immediately take the corrective measures necessary to bring the regulated measuring instrument into conformity, or withdraw or recall it, if appropriate.
(3) Where the regulated measuring instrument presents a risk, the distributor must immediately inform the competent authority to that effect, giving details, in particular, of the non-compliance of the instrument and of the corrective measures taken by that distributor.
Provision of information to the competent authority
(1) The distributor must, further to a reasoned request from a competent authority, provide that authority with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the regulated measuring instrument with the requirements of these Regulations.
(2) Information and documentation supplied to a competent authority pursuant to this regulation must be supplied in English.
(3) A distributor must co-operate with a competent authority, at its request, as regards any action to eliminate the risks posed by any regulated measuring instrument that the distributor has placed on the market.
CHAPTER 4 — IDENTIFICATION OF ECONOMIC OPERATORS
(1) Economic operators must, on request, identify to the market surveillance authorities—
(a) any economic operator who has supplied them with a regulated measuring instrument; and
(b) any economic operator to whom they have supplied a regulated measuring instrument.
(2) Economic operators must be able to present the information referred to in paragraph (1) for 10 years beginning with the day after the day on which they have been supplied with the regulated measuring instrument and for 10 years day beginning with the day after the day they have supplied the instrument.
(3) The Secretary of State may impose a monetary penalty on an economic operator who fails to comply with an obligation imposed on it under this regulation.
(4) Schedule 7 has effect in relation to a monetary penalty imposed under paragraph (3).
Obligations which are met by complying with obligations in the Directive
(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 4(22);
(c) “ Module B ” means the conformity assessment procedure set out under the heading “MODULE B: EU-TYPE EXAMINATION” in Annex II;
(d) “ Module H1 ” means the conformity assessment procedure set out under the heading “MODULE H1: CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION” in Annex II;
(e) “ EU-design examination certificate ” means an EU design certificate issued in accordance with Module H1;
(f) “ EU-type examination certificate ” means an EU-type examination certificate issued in accordance with Module B;
(g) “ harmonised standard ” has the meaning given to it in Article 4(14);
(h) “ instrument-specific Annexes ” means Annexes III to XII.
(2) Paragraph (3) applies where, before placing a regulated measuring instrument on the market, the manufacturer—
(a) ensures that the regulated measuring instrument has been designed and manufactured in accordance with the essential requirements set out in Annex I and in the relevant instrument-specific Annex which applies to the regulated measuring instrument;
(b) ensures that the one of the relevant conformity assessment procedures listed in the relevant instrument-specific Annex that apply to that regulated measuring instrument in accordance with Article 17 have been carried out;
(c) draws up the technical documentation referred to in Article 18;
(d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in or translated into English;
(e) affixes a CE marking and the supplementary metrology marking, in accordance with Articles 21 and 22(1) to (6);
(f) draws up an EU declaration of conformity, in accordance with Article 19; 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 7(a) to (e), 48 and 52(2) are to be treated as being satisfied;
(b) regulations 8, 9(2), 51, 68(1)(a) to (e), 72, 73 and 75 apply subject to the modifications in paragraph (8); and
(c) regulations 36 to 39 do not apply.
(4) Paragraph (5) applies where, before placing a regulated measuring instrument on the market, the importer ensures that—
(a) the relevant conformity assessment procedures that apply to that measuring instrument in accordance with Article 17 have been carried out;
(b) the manufacturer has drawn up the technical documentation referred to in Article 18; and
(c) the measuring instrument bears the CE marking, and the supplementary metrology marking referred to in Article 21(2).
(5) Where this paragraph applies—
(a) the requirements of regulation 17(2)(a) to (c) are to be treated as being satisfied; and
(b) regulations 18, 21, 23, 51, 68(1)(a) to (e), 72, 73 and 75 apply subject to the modifications in paragraph (8).
(6) Paragraph (7) applies where, before making a regulated measuring instrument available on the market, a distributor ensures that the regulated measuring instrument bears the CE marking, and the supplementary metrology marking referred to in Article 21(2).
(7) Where this paragraph applies—
(a) regulation 28(1) is to be treated as being satisfied; and
(b) regulations 29(1),30, 68(1)(a), 68(1)(b), 72 and 73 apply subject to the modifications in paragraph (8).
(8) The modifications referred to in paragraphs (3)(b), (5)(b) and (7)(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) except in relation to regulations 72 and 73, any reference to “essential requirements” is to be read as a reference to the essential requirements referred to in Annex I and in the relevant instrument-specific Annex which applies to the regulated measuring instrument;
(d) any reference to “designated standard” is to be read as a reference to a harmonised standard;
(e) any reference to “ ... conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedures that apply to the regulated measuring instrument in accordance with Article 17;
(f) any reference to “ technical documentation ” is a reference to the technical documentation referred to in Article 18;
(g) any reference to “type examination certificate” is to be read as a reference to an EU-type examination certificate; and
(h) any reference to “design examination certificate” is to be read as a reference to an EU-design examination certificate;
(i) any reference to “M marking” is to be read as a reference to the supplementary metrology marking; and
(j) any reference to “approved body” is to be read as a reference to the body that undertook any conformity assessment procedure in accordance with Article 13;
(k) any reference to “ authorised mark ” includes the CE marking and the supplementary metrology marking.
Conformity assessment procedure obligation which is met by complying with the Directive
(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) “ Module B ” means the conformity assessment procedure set out under the heading “MODULE B: EU-TYPE EXAMINATION” in Annex II;
(c) “ EU-type examination certificate ” means an EU-type examination certificate issued in accordance with Module B;
(d) “ harmonised standard ” has the meaning given to it in Article 4(14);
(e) “ instrument-specific Annexes ” means Annexes III to XII.
(2) Paragraph (3) applies where—
(a) in accordance with Article 17, one of the conformity assessment procedures listed in the instrument-specific Annex that applies to the regulated measuring instrument is Module B; and
(b) before placing a regulated measuring instrument on the market, the manufacturer ensures that—
(i) the regulated measuring instrument has been designed in accordance with the essential requirements set out in Annex I and in the relevant instrument-specific Annex which applies to the regulated measuring instrument; and
(ii) Module B has been complied with in respect of that regulated measuring instrument.
(3) Where this paragraph applies—
(a) any reference in regulation 7(c) to “ relevant conformity assessment procedure ” includes Module B;
(b) any reference to “type examination certificate” in regulations 45(1)(j), 72(3)(b) and 73(3)(b) is to be read as a reference to “EU-type examination certificate”; and
(c) any reference to “designated standard” in regulation 45(1)(f) is to be read as a reference to “harmonised standard.
Further use of UK marking
(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 4(14);
(c) “ instrument-specific Annexes ” means Annexes III to XII.
(2) Paragraph (3) applies where, before placing a regulated measuring instrument on the market, the manufacturer—
(a) ensures that the regulated measuring instrument has been designed and manufactured in accordance with the essential requirements set out in Annex I and in the relevant instrument-specific Annex which applies to the regulated measuring instrument;
(b) ensures that one of the relevant conformity assessment procedures listed in the relevant instrument-specific Annex that apply to that regulated instrument in accordance with Article 17 has been carried out;
(c) draws up the technical documentation referred to in Article 18; and
(d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in or translated into English.
(3) Where this paragraph applies—
(a) the requirements of regulations 7(1)(a) to (c), 44 and 45 are to be treated as being satisfied;
(b) except for regulations 47 to 52(1) to (7), Part 4 does not apply;
(c) regulations 8, 9, 15, 17(2)(a) and (b), 18, 21, 24, 29, 30, 51, 63, 68 and 76 apply subject to the modifications in paragraph (4);
(d) regulation 47 and Schedule 1K apply subject to the modifications in paragraphs (4) and (5);
(e) regulations 48, 52, 72 and 73 apply subject to the modifications in paragraph (5).
(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 referred to in Annex I and in the relevant instrument-specific Annex which applies to the regulated measuring instrument;
(b) any reference to “designated standard” is to be read as a reference to a harmonised standard;
(c) any reference to “conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedure that applies to the regulated measuring instrument in accordance with Article 17;
(d) any reference to “technical documentation” is to be read as a reference to the technical documentation referred to in Article 18.
(5) The modifications referred to in paragraph (3)(d) and (e) are that—
(a) in regulations 47(1)(b) and 52 any reference to “Schedule 1B” is to be read as a reference to Annex II;
(b) in regulation 48 any reference to “enactment” is to be read as including the Directive;
(c) regulation 52(10) is to be read as if the words beginning with “and” and ending with “body” were omitted;
(d) in regulations 72(3)(b) and 73(3)(b)—
(i) any reference to “type examination certificate” is to be read as a reference to an EU-type examination certificate issued under the conformity assessment procedure set out under the heading “MODULE B: EU TYPE EXAMINATION” in Annex II;
(ii) any reference to “design examination certificate” is to be read as a reference to an EU-design examination certificate issued in accordance with the conformity assessment procedure set out under the heading “MODULE H1: CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION” in Annex II.
(e) in Schedule 1K—
(i) in paragraph 5 the reference to “relevant 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 any conformity assessment body that undertook a conformity assessment procedure in respect of the regulated measuring instrument in accordance with Article 17.
Qualifying Northern Ireland Goods
(1) Where paragraph (2) applies—
(a) a regulated measuring instrument is to be treated as being in conformity with the essential requirements; and
(b) each relevant economic operator is to be treated as having complied or as complying with the obligations imposed on them under Part 2.
(2) This paragraph applies where—
(a) a regulated measuring instrument is—
(i) in conformity with the essential requirements, within the meaning of that term in regulation 2, as it applies in Northern Ireland; and
(ii) qualifying Northern Ireland goods; and
(b) each relevant economic operator has complied or is complying with the obligations imposed on them under Part 2, as that Part applies in Northern Ireland; and
(c) an importer has complied with the obligations set out in paragraph (3).
(3) The obligations referred to in paragraph (2)(c) are that, before placing the non-automatic weighing instrument on the market, the importer—
(a) complies with regulation 19;
(b) ensures that—
(i) the relevant conformity assessment procedure has been carried out.
(ii) the manufacturer has drawn up the technical documentation; and
(iii) the regulated measuring instrument bears the CE marking.
(3A) After a regulated measuring instrument has been placed on the market pursuant to this regulation, regulations 72 and 73 are to be read in relation to that instrument subject to the following modifications—
(a) the reference in regulation 72(2)(a) to “UK marking” is to be read as a reference to the CE marking, within the meaning of regulation 2(1) as it applies in Northern Ireland;
(b) the reference in regulation 72(2)(b) to “M marking”, is to be read as a reference to the M Marking as defined in regulation 2(1) as it applies in Northern Ireland;
(c) the reference in regulation 72(2)(c) to “approved body” is to be read as a reference to a “notified body” as defined in regulation 2(1) as it applies in Northern Ireland;
(d) the references in regulations 72(3)(a) and 73(3)(a) to “essential requirements” are to be read as the essential requirements within the meaning of that term in regulation 2(1) as it applies in Northern Ireland; and
(e) the references in regulations 72(3)(b) and 73(3)(b) to “type examination certificate” is to be read as a reference to an EU-type examination certificate as defined in regulation 2(1) as it applies in Northern Ireland.
(4) In this regulation—
“ CE marking ” has the meaning given it in 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 ” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland.
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