The Measuring Instruments Regulations 2016

CHAPTER 1 U.K. ESTABLISHING COMPLIANCE WITH THE ESSENTIAL REQUIREMENTS

Introductory E+W+S

[F1 36.   This chapter applies for the purposes of establishing whether a regulated measuring instrument complies with the essential requirements.]

Extent Information

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

Textual Amendments

F1 Reg. 36 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. 27 para. 20 (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Introductory N.I.

36.  This chapter applies for the purposes of establishing whether a measuring instrument (whether it is a regulated measuring instrument or a non-prescribed measuring instrument) complies with the essential requirements.

Extent Information

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

Methods of establishing conformity with the essential requirements E+W+S

37.  Conformity with the essential requirements may be established in relation to a [F2 regulated] measuring instrument—

(a) through conformity with [F3 designated] standards (or parts of those standards) covering the essential requirements F4 ...;

(b) through conformity with parts of normative documents which cover the essential requirements where the parts of the normative documents have been included in a list published [F5 by the Secretary of State]; or

(c) through the use by the manufacturer of any other technical solution that complies with the essential requirements.

Extent Information

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

Textual Amendments

F2 Word in reg. 37 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. 27 para. 21(a) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F3 Word in reg. 37(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. 27 para. 21(b)(i) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in reg. 37(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. 27 para. 21(b)(ii) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in reg. 37(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. 27 para. 21(c) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Methods of establishing conformity with the essential requirements N.I.

37.  Conformity with the essential requirements may be established in relation to a measuring instrument—

(a) through conformity with harmonised standards (or parts of those standards) covering the essential requirements where the harmonised standards have been published in the Official Journal of the European Union;

(b) through conformity with parts of normative documents which cover the essential requirements where the parts of the normative documents have been included in a list published in the Official Journal of the European Union; or

(c) through the use by the manufacturer of any other technical solution that complies with the essential requirements.

Extent Information

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

Presumptions of conformity of [F6 regulated] measuring instruments E+W+S

38.—(1)  [F7 Regulated] measuring instruments which are in conformity with [F8 designated] standards (or parts of those standards) of a kind mentioned in regulation 37(a), are to be presumed to be in conformity with the essential requirements covered by those standards (or parts of those standards).

(2) [F9 Regulated] measuring instruments which are in conformity with parts of normative documents of a kind mentioned in regulation 37(b), are to be presumed to be in conformity with the essential requirements covered by those parts of normative documents.

(3) To benefit from a presumption of conformity under paragraphs (1) or (2), the manufacturer must correctly apply solutions mentioned in the relevant [F10 designated] standards or in the normative documents.

(4) Compliance with the appropriate tests mentioned in regulation 45(1)(i) is to be presumed if the corresponding test programme has been performed in accordance with the documents mentioned in paragraphs (1) and (2) and if the test results ensure compliance with the essential requirements.

Extent Information

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

Textual Amendments

F6 Word in reg. 38 heading 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. 27 para. 22(a) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F7 Word 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. 27 para. 22(a) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F8 Word in reg. 38(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. 27 para. 22(b) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F9 Word in reg. 38(2) 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. 27 para. 22(a) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F10 Word in reg. 38(3) 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. 27 para. 22(b) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Presumptions of conformity of measuring instruments N.I.

38.—(1) Measuring instruments which are in conformity with harmonised standards (or parts of those standards) of a kind mentioned in regulation 37(a), are to be presumed to be in conformity with the essential requirements covered by those standards (or parts of those standards).

(2) Measuring instruments which are in conformity with parts of normative documents of a kind mentioned in regulation 37(b), are to be presumed to be in conformity with the essential requirements covered by those parts of normative documents.

(3) To benefit from a presumption of conformity under paragraphs (1) or (2), the manufacturer must correctly apply solutions mentioned in the relevant harmonised standards or in the normative documents.

(4) Compliance with the appropriate tests mentioned in regulation 45(1)(i) is to be presumed if the corresponding test programme has been performed in accordance with the documents mentioned in paragraphs (1) and (2) and if the test results ensure compliance with the essential requirements.

Extent Information

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

Conformity assessment procedures E+W+S

39.—(1) Conformity assessment of a [F11 regulated] measuring instrument with the essential requirements must be established by the application at the choice of the manufacturer, of one of the conformity assessment procedures listed as applicable in relation to the [F11 regulated] measuring instrument in Schedule [F12 1C to 1J].

(2) [F13 An approved] body must carry out the conformity assessment procedure selected by the manufacturer in accordance with the requirements of Schedule 4.

(3) The documents and correspondence relating to the conformity assessment procedures referred to in this regulation which are carried out in the United Kingdom must be drawn up in English.

Extent Information

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

Textual Amendments

F11 Word in reg. 39(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. 27 para. 23(a)(i) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F12 Words in reg. 39(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. 27 para. 23(a)(ii) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F13 Words in reg. 39(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. 27 para. 23(b) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Conformity assessment procedures N.I.

39.—(1) Conformity assessment of a measuring instrument with the essential requirements must be established by the application at the choice of the manufacturer, of one of the conformity assessment procedures listed as applicable in relation to the measuring instrument in Schedule 1.

(2) A notified body must carry out the conformity assessment procedure selected by the manufacturer in accordance with the requirements of Schedule 4.

(3) The documents and correspondence relating to the conformity assessment procedures referred to in this regulation which are carried out in the United Kingdom must be drawn up in English.

Extent Information

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

[F14 Power to amend Schedules 1C to 1J E+W+S

39A.— (1) Where the one or more of the conditions in paragraph (2) are met, the Secretary of State may by regulations make provision to amend Schedules 1C to 1J in relation to any of the following matters—

(a) maximum permissible errors (MPEs) and accuracy classes;

(b) rated operating conditions;

(c) critical change values; and

(d) disturbances.

(2) The conditions referred to in paragraph (1) are that the Secretary of State considers that the purpose of the provision is to—

(a) take into account scientific or technical progress; or

(b) provide adequate protection of consumers or other end users.

(3) The power to make regulations under this regulation includes the power—

(a) to make different provision for different cases; and

(b) to make such supplemental, consequential and transitional provision as the Secretary of State considers appropriate

(4) Regulations made under paragraph (1) are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.]

Textual Amendments

F14 Reg. 39A 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. 27 para. 24 (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Capacity serving measures - accredited in house bodies E+W+S

40.—(1) This regulation applies to the conformity assessment of capacity serving measures.

(2) An accredited in-house body may be used to carry out conformity assessment activities for the undertaking of which it forms part for the purposes of implementing the procedures set out in Module A2 [F15 in Schedule 1B].

(3) The body must constitute a separate and distinct part of the undertaking and must not participate in the design, production, supply, installation, use or maintenance of the [F16 regulated] measuring instrument it assesses.

(4) An accredited in-house body must meet the following requirements—

(a) it must be accredited in accordance with RAMS;

(b) the body and its personnel must be organisationally identifiable and have reporting methods within the undertaking of which they form a part which ensure their impartiality and demonstrate it to the relevant national accreditation body;

(c) neither the body, nor its personnel shall be responsible for the design, manufacture, supply, installation, operation or maintenance of the [F17 regulated] measuring instruments they assess nor shall they engage in any activity that might conflict with their independence of judgment or integrity in relation to their assessment activities; and

(d) it must supply its services exclusively to the undertaking of which it forms a part.

[F18 (5) An accredited in-house body need not be approved by the Secretary of State, but information concerning its accreditation must be given by the undertaking of which it forms part to the Secretary of State at the request of the Secretary of State.]

Extent Information

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

Textual Amendments

F15 Words in reg. 40(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. 27 para. 25(a) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F16 Word in reg. 40(3) 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. 27 para. 25(b) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F17 Word in reg. 40(4)(c) 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. 27 para. 25(b) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F18 Reg. 40(5) 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. 27 para. 25(c) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Capacity serving measures - accredited in house bodies N.I.

40.—(1) This regulation applies to the conformity assessment of capacity serving measures.

(2) An accredited in-house body may be used to carry out conformity assessment activities for the undertaking of which it forms part for the purposes of implementing the procedures set out in Module A2 of Annex II to the Directive.

(3) The body must constitute a separate and distinct part of the undertaking and must not participate in the design, production, supply, installation, use or maintenance of the measuring instrument it assesses.

(4) An accredited in-house body must meet the following requirements—

(a) it must be accredited in accordance with RAMS;

(b) the body and its personnel must be organisationally identifiable and have reporting methods within the undertaking of which they form a part which ensure their impartiality and demonstrate it to the relevant national accreditation body;

(c) neither the body, nor its personnel shall be responsible for the design, manufacture, supply, installation, operation or maintenance of the measuring instruments they assess nor shall they engage in any activity that might conflict with their independence of judgment or integrity in relation to their assessment activities; and

(d) it must supply its services exclusively to the undertaking of which it forms a part.

(5) An accredited in-house body need not be notified to the notifying authority or the Commission, but information concerning its accreditation must be given by the undertaking of which it forms part to the notifying authority at the request of that authority.

Extent Information

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

Subsidiaries and contractors E+W+S

[F19 41.— (1) An approved body may subcontract specific conformity assessment activities, or use a subsidiary to carry out such activities provided—

(a) the body is satisfied that the subcontractor or subsidiary meets the approved body requirements;

(b) the body has informed the Secretary of State that it is satisfied that the subcontractor or subsidiary meets those requirements; and

(c) the economic operator for whom the activities are to be carried out has consented to the activities being carried out by that person.

(2) The approved body which subcontracts specific conformity assessment activities or uses a subsidiary to carry out such activities remains responsible for the proper performance of those activities (irrespective of where the subcontractor or subsidiary is established).

(3) Where an approved body subcontracts, or uses a subsidiary to carry out, a specific conformity assessment activity, the approved body must, for a period of 10 years beginning on the day on which the activity is first carried out, keep available for inspection by the Secretary of State all relevant documentation concerning—

(a) the assessment of the qualifications of the subcontractor or the subsidiary; and

(b) the conformity assessment activity carried out by the subcontractor or subsidiary.

(4) In this regulation “subsidiary” has the meaning given to it in section 1159 of the Companies Act 2006.]

Extent Information

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

Textual Amendments

F19 Reg. 41 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. 27 para. 26 (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Subsidiaries and contractors N.I.

41.—(1) Where a notified body subcontracts specific conformity assessment activities, or has such activities carried out by a subsidiary, the activities are only to be treated as having been carried out by a notified body for the purposes of regulation 39 (conformity assessment procedures) where the conditions in paragraphs (2) and (3) are met.

(2) The notified body must—

(a) ensure that the subcontractor or subsidiary meets the notified body requirements; and

(b) inform the Secretary of State accordingly.

(3) The notified body must have obtained the agreement of the client to the use of a subcontractor or subsidiary.

(4) Where a notified body subcontracts specific conformity assessment activities, or has such activities carried out by a subsidiary, the notified body must for a period of at least 10 years beginning on the day on which the activities are carried out, keep at the disposal of the Secretary of State the documentation concerning—

(a) the assessment of the qualifications of the subcontractor or the subsidiary; and

(b) the conformity assessment activities carried out by the subcontractor or subsidiary.

(5) When monitoring a notified body in accordance with regulation 58 (monitoring), the Secretary of State must treat the notified body as responsible for the tasks performed by a subcontractor or subsidiary, wherever the subcontractor or subsidiary is established.

Extent Information

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

Fees E+W+S

42.—(1)  [F20 An approved] body may charge fees in connection with, or incidental to, the carrying out of conformity assessment procedures or specific tasks as it may determine.

(2) The fees referred to in paragraph (1) must not exceed the following—

(a) the costs incurred or to be incurred by the [F21 approved] body in performing the relevant function; and

(b) an amount on account of profit which is reasonable in the circumstances having regard to—

(i) the character and extent of the work done or to be done by that notified body on behalf of the applicant; and

(ii) the commercial rate normally charged on account of profit for that work or similar work.

(3) The power in paragraph (1) includes the power to require payment of fees or a reasonable estimate of such fees in advance of carrying out the work requested by the applicant.

(4) Where any fees payable to [F20 an approved] body pursuant to this regulation remain unpaid 28 days after either the work has been requested or payment of the fees has been requested in writing, whichever is the later, the notified body may by 14 days' notice in writing provide that, unless the fees are paid before the expiry of the notice, the certificate or notification appropriate to the relevant conformity assessment procedure may be suspended until payment of the fees has been received.

(5) This regulation does not apply to the Secretary of State.

Extent Information

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

Textual Amendments

F20 Words in reg. 42 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. 27 para. 27(a) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F21 Word in reg. 42(2)(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. 27 para. 27(b) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Fees N.I.

42.—(1) A United Kingdom notified body may charge fees in connection with, or incidental to, the carrying out of conformity assessment procedures or specific tasks as it may determine.

(2) The fees referred to in paragraph (1) must not exceed the following—

(a) the costs incurred or to be incurred by the United Kingdom notified body in performing the relevant function; and

(b) an amount on account of profit which is reasonable in the circumstances having regard to—

(i) the character and extent of the work done or to be done by that notified body on behalf of the applicant; and

(ii) the commercial rate normally charged on account of profit for that work or similar work.

(3) The power in paragraph (1) includes the power to require payment of fees or a reasonable estimate of such fees in advance of carrying out the work requested by the applicant.

(4) Where any fees payable to a United Kingdom notified body pursuant to this regulation remain unpaid 28 days after either the work has been requested or payment of the fees has been requested in writing, whichever is the later, the notified body may by 14 days' notice in writing provide that, unless the fees are paid before the expiry of the notice, the certificate or notification appropriate to the relevant conformity assessment procedure may be suspended until payment of the fees has been received.

(5) This regulation does not apply to the Secretary of State.

Extent Information

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