The Measuring Instruments Regulations 2016

• Citation: S.I. 2016/1153
• Sections: 616

Section 1 Citation, commencement and extent

(1) These Regulations may be cited as the Measuring Instruments Regulations 2016.

(2) These Regulations come into force on 28th December 2016.

(3) These Regulations extend to Northern Ireland except Part 6.

Section 2 Interpretation

(1) In these Regulations—

“ the 1985 Act ” means the Weights and Measures Act 1985;

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“ active electrical energy meter ” means a device which measures the active electrical energy consumed in a circuit which is intended for residential, commercial or light industrial use;

“ approved body ” has the meaning given to it in regulation 53 (approved bodies);

“ authorised representative ” means any person established in the United Kingdom who has received a written mandate from a manufacturer to act on the manufacturer's behalf in relation to specified tasks;

“ automatic weighing instrument ” means an instrument that—

determines the mass of a product without the intervention of an operator; and

follows a predetermined programme of automatic processes characteristic of the instrument intended to determine the mass of a body by using the action of gravity on that body;

“ automatic gravimetric filing instrument ” means an automatic weighing instrument that fills containers with a predetermined and virtually constant mass of product from bulk;

“ automatic catchweigher ” means an automatic weighing instrument that determines the mass of pre-assembled discrete loads (for example pre-packages) or single loads of loose material;

“ automatic checkweigher ” means an automatic catchweigher which sub-divides articles of different mass into two or more sub-groups according to the value of the difference between their mass and the nominal set point;

“ automatic discontinuous totaliser ” means an automatic weighing instrument that—

determines the mass of a bulk product by dividing the product into discrete loads;

determines in sequence and sums the mass of each discrete load; and

delivers each discrete load to bulk;

“ automatic rail-weighbridge ” means an automatic weighing instrument having a load receptor inclusive of rails for conveying railway vehicles;

“ automatic weight grading instrument ” means an instrument which sub-divides articles of different mass into several sub-groups, each characterised by a given mass range;

“ beltweigher ” means an automatic weighing instrument that continuously determines the mass of a bulk product on a conveyor belt without systematic subdivision of the product without interrupting the movement of the conveyor belt;

“ capacity serving measure ” means a capacity serving measure (such as a drinking glass, jug or thimble measure) designed to determine a specified volume of a liquid (other than a pharmaceutical product) which is sold for immediate consumption;

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“ commencement date ” means the date referred to in regulation 1(2);

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“ competent authority ” means any person who is pursuant to regulation 67 (enforcement of the Regulations), authorised to enforce these Regulations;

“ compliance notice ” means a notice served in accordance with regulation 68(2);

“ conformity assessment ” means the process demonstrating whether the essential requirements relating to a regulated measuring instrument have been met;

“ conformity assessment body ” means a body that performs conformity assessment activities including calibration, testing, certification and inspection;

“ declaration of conformity ” means a declaration of conformity required to be drawn up in accordance with chapter 3 of Part 4;

“ designated standard ” has the meaning given to it in regulation 2A;

“ design examination certificate ” means a design certificate issued by an approved body in accordance with Module H1 in Schedule 1B

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“ the Directive ” means Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments ...;

“disqualification mark” means a marking in the form set out in paragraph 1 of Schedule A1;

“ distributor ” means any person in the supply chain, other than a manufacturer or an importer, who makes a regulated measuring instrument available on the market;

“ economic operator ” means a manufacturer, authorised representative, importer or distributor;

“ enforcement notice ” means a notice served in accordance with regulation 69(2);

“ enforcement officer ” means—

an inspector; or

a person appointed by the Secretary of State to act on the Secretary of State's behalf to enforce these Regulations;

“ essential requirements ” means, in relation to a regulated measuring instrument (or a class of that measuring instrument), the requirements specified as being applicable in relation to that measuring instrument (or that class) in Schedule 1A and 1C to 1J ;

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“ exhaust gas analyser ” means a regulated measuring instrument that serves, in relation to a motor vehicle engine with spark ignition, to determine at the moisture level of the sample analysed the volume fractions of the following exhaust gas components—

carbon monoxide;

carbon dioxide;

oxygen; and

hydrocarbons;

“ gas meter ” means an instrument designed to measure, memorise and display the quantity of fuel gas (volume or mass) that has passed it which is intended for residential, commercial or light industrial use;

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“ importer ” means a person who—

is established in the United Kingdom and places a regulated measuring instrument from a country outside of the United Kingdom on the market; or

is established in Northern Ireland and places a regulated measuring instrument on the market that has been supplied to them for distribution, consumption or use in the course of a commercial activity, whether in return for payment or free of charge, from an EEA state;

“ in writing ” includes text that is—

transmitted by electronic means;

received in legible form; and

capable of being used for subsequent reference;

“ M marking ” means a marking applied to a regulated measuring instrument which consists of the capital letter ‘M’ and the last two digits of the year of its affixing surrounded by a rectangle, the height of which is equal to that of the UK marking applied to that instrument;

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“ make available on the market ” means any supply of a regulated measuring instrument for distribution, or use on market of Great Britain in the course of a commercial activity, whether in return for payment or free of charge, and related expressions are to be construed accordingly;

“ manufacturer ” means a person who—

manufactures a regulated measuring instrument, or has a regulated measuring instrument designed or manufactured, and markets that regulated measuring instrument under their name or trade mark; or

is to be treated as a manufacturer by virtue of regulation 6(2);

“ market surveillance authority ” means the Secretary of State acting in the capacity of the market surveillance authority pursuant to the designation made by regulation 62 (the market surveillance authority) ...;

“ material measure ” means—

a material measure of length; or

a capacity serving measure;

“ material measure of length ” means an instrument comprising scale marks whose distances are given in legal units of length;

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“ non-water liquid measuring system ” means a measuring system for the continuous and dynamic measurement of quantities of liquids other than water where—

the system comprises a meter and all devices required to ensure correct measurement or intended to facilitate the measuring operations; and

the expression “ meter ” means an instrument designed to measure continuously, memorise and display the quantity at metering conditions of liquid flowing through the measurement transducer in a closed, fully charged conduit;

“ normative document ” means a document containing technical specifications adopted by the International Organisation of Legal Metrology;

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“ place on the market ” means the first making available of a regulated instrument on the market of Great Britain and related expressions are to be construed accordingly;

“ putting into use ” means the first use of a regulated measuring instrument intended for the end-user for the purposes for which it was intended and related expressions are to be construed accordingly;

“ RAMS ” means Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (as from time to time amended);

“ recall ” means any measure aimed at achieving the return of a regulated measuring instrument that has already been made available to the end-user and related expressions are to be construed accordingly;

“ regulated measuring instrument ” means an instrument of the kind referred to in regulation 3(2);

“ relevant conformity assessment procedure ” means, in relation to a particular regulated measuring instrument, a conformity assessment procedure specified in Schedules 1C to 1J as being applicable to that instrument;

“ relevant economic operator ” means, in relation to a regulated measuring instrument, an economic operator with obligations in respect of that regulated measuring instrument under Part 2;

“re-qualification mark” means a marking in the form set out in paragraph 2 of Schedule A1;

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“ taximeter ” means a device that works together with a signal generator to make a regulated measuring instrument with the device measuring duration, calculating distance on the basis of a signal delivered by the distance signal generator and calculating and displaying the fare to be paid for a trip on the basis of the calculated distance or the measured duration of the trip, or both;

“ technical documentation ” means documentation prepared in accordance with Chapter 2 of Part 4;

“ technical specification ” means a document that prescribes technical requirements to be fulfilled by a regulated measuring instrument;

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“ type examination certificate ” means a type examination certificate issued by an approved body in accordance with Module B in Schedule 1B;

“ UK marking ” means the marking in the form set out in Annex 2 of RAMS;

“ UK national accreditation body ” means the body appointed by the Secretary of State in accordance with Article 4 of RAMS;

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“ water meter ” means an instrument designed to measure, memorise and display, the volume at metering conditions of water passing through the measurement transducer for the measurement of volumes of clean, cold or heated water intended for residential, commercial or light industrial use

“ weights and measures authority ” means a local weights and measures authority within the meaning set out in section 69 of the Weights and Measures Act 1985 ; and

“withdraw”, when used in relation to a regulated measuring instrument, means taking any measure aimed at preventing a regulated measuring instrument in the supply chain from being made available on the market and related expressions are to be construed accordingly.

(1A) Schedules 1A to 1J reproduce the provisions of Annexes I to V, VII to X and XII to the Directive (respectively) with amendments to correct deficiencies in assimilated law.

(1B) A reference to a provision of Schedules 1A to 1J is a reference to the equivalent provision of the relevant Annex to the Directive as set out in the relevant Schedule.

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

(3) Other expressions used in these Regulations have in relation to the application of these Regulations to—

(a) Great Britain, the same meanings as in the Weights and Measures Act 1985; and

(b) Northern Ireland, the same meanings as it the Weights and Measures (Northern Ireland) Order 1981 .

Section 2A Designated standard

(1) Subject to paragraphs (6) and (7), in these Regulations a “ designated standard ” means a technical specification which is—

(a) adopted by a recognised standardisation body or an international standardising body , for repeated or continuous application, with which compliance is not compulsory; and

(b) designated by the Secretary of State by publishing the reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate.

(2) For the purposes of paragraph (1), a “ technical specification ” means a document that prescribes technical requirements to be fulfilled by a regulated measuring instrument, process, service or system and which lays down one or more of the following—

(a) the characteristics required of a regulated measuring instrument, including—

(i) levels of quality, performance, interoperability, environmental protection, health, safety or dimensions, and

(ii) the requirements applicable to the regulated measuring instrument as regards the name under which the regulated measuring instrument is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; and

(b) production methods and processes relating to the regulated measuring instrument, where these have an effect on the characteristics of the regulated measuring instrument.

(3) For the purposes of this regulation a “ recognised standardisation body ” means any one of the following organisations—

(a) the European Committee for Standardisation (CEN);

(b) the European Committee for Electrotechnical Standardisation (Cenelec);

(c) the European Telecommunications Standards Institute (ETSI);

(d) the British Standards Institution (BSI).

(3A) In this regulation “ international standardising body ” has the same meaning as it has for the purposes of the Agreement on Technical Barriers to Trade, part of Annex 1A to the agreement establishing the World Trade Organisation signed at Marrakesh on 15 April 1994 (as modified from time to time).

(4) When considering whether the manner of publication of a reference is appropriate in accordance with paragraph (1)(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard.

(5) Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with such technical specifications adopted by the other recognised standardisation bodies or by international standardising bodies as the Secretary of State considers to be relevant .

(6) The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph (1)(b).

(7) Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.

(8) The Secretary of State may by regulations amend paragraph (3) to reflect any changes in the name or structure of the recognised standardisation bodies.

(9) Regulations made under paragraph (8) are to be made by statutory instrument.

(10) A statutory instrument containing regulations made under paragraph (9) is subject to annulment in pursuance of a resolution of either House of Parliament.

Section 3 Meaning of “ regulated measuring instrument” ... and application of these Regulations

(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) In these Regulations a reference to a regulated measuring instrument means a measuring instrument of any of the following descriptions —

(a) water meters used for trade for the supply of potable water in the temperature range from 0.1°C to and including 30°C;

(b) gas meters for use for trade except a gas meter which is used under an agreement providing for the supply of a quantity of gas at a rate of flow which, if measured at a temperature of 15°C and a pressure of 1013.25 millibars, would exceed 1600 cubic meters an hour (or the equivalent quantity in kilograms);

(c) active electrical energy meters for use for trade other than an instrument which is used under an agreement providing for the supply of active electrical energy where—

(i) the maximum quantity supplied exceeds 100 kilowatts per hour; and

(ii) the instrument provides measurement on a half-hourly basis;

(d) non-water liquid measuring systems for use for trade of the following descriptions—

(i) a measuring system which is used for the continuous and dynamic measurement in a quantity not exceeding 100 litres or 100 kilograms of a liquid fuel, lubricant or a mixture of fuel and lubricant other than—

(aa) liquefied petroleum gas; or

(bb) liquefied natural gas;

(ii) a measuring system (other than one used in connection with the refuelling of aircraft, ships or hovercraft) which is used for the continuous and dynamic measurement in a quantity exceeding 100 litres or 100 kilograms of liquid fuel delivered from a road tanker other than—

(aa) liquefied gases;

(bb) lubricating oils;

(cc) liquid fuels of a temperature below -153°C; or

(dd) liquid fuels of a dynamic viscosity exceeding 100 millipascal seconds at 15°C;

(e) automatic weighing instruments of the following kinds which are for use for trade—

(i) automatic gravimetric filling instruments;

(ii) automatic catchweighers (other than automatic checkweighers and automatic weight grading instruments);

(iii) automatic rail-weighbridges;

(iv) beltweighers; and

(v) discontinuous totalisers;

(f) taximeters intended for use for the protection of consumers;

(g) material measures which are for use for trade of the following kinds—

(i) material measures of length (excluding dipping and strapping tapes);

(ii) capacity serving measures for the measurement of draft beer or cider of the following capacities: 1 / 3 pint, ½ pint, 2 / 3 pint, 1 pint, 2 pints, 4 pints, 8 pints and 16 pints;

(iii) capacity serving measures for the measurement of liquids other than draft beer or cider of the following capacities in millilitres (ml) and litres (l): 5 ml, 10 ml, 20 ml, 25 ml, 35 ml, 50 ml, 70 ml, 100 ml, 125 ml, 150 ml, 175 ml, 200 ml, 250 ml, 500 ml, 1 l, 2 l, 2.5 l, 5 l, 10 l and 20 l;

(h) exhaust gas analysers intended for use for the protection of the environment and public health except where the exhaust gas analyser includes or is connected to a device which is not used for the protection of the environment and public health;

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(4) These Regulations do not apply to the putting into use of the instruments listed in Schedule 2.

Section 4 Revocations and transitional and consequential provisions

Schedule 3 (revocations, and transitional and consequential provisions) has effect.

Section 5 Exception for trade fairs, exhibitions and demonstration

Nothing in these Regulations prevents the showing and use of a regulated measuring instrument which is not in conformity with the requirements of these Regulations at a trade fair, exhibition or demonstration for the marketing of regulated measuring instruments, provided that a visible sign clearly indicates—

(a) the name and date of the trade fair or exhibition;

(b) that the instrument is not in conformity with these Regulations; and

(c) that the instrument is not available for sale until brought into conformity with these Regulations.

Section 6 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.

Section 7 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.

Section 8 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.

Section 9 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.

Section 10 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.

Section 11 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.

Section 12 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.

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(4) Such instructions and information (and any labelling) relating to a regulated measuring instrument must be clear, legible and in easily understandable English .

Section 13 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.

Section 14 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.

Section 15 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.

Section 16 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.

Section 17 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).

Section 18 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.

Section 19 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.

Section 20 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.

Section 21 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.

Section 22 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.

Section 23 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.

Section 24 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.

Section 25 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.

Section 26 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.

Section 27 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.

Section 28 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).

Section 29 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.

Section 30 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.

Section 31 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.

Section 32 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.

Section 33

(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).

Section 33A 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.

Section 33B 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.

Section 33C 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.

Section 33D 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.

Section 34 Introductory

This Part applies where a manufacturer wishes to place on the market or put into use a non-prescribed measuring instrument in another EEA state where that measuring instrument must comply with the essential requirements under the law relating to legal metrological control of that EEA state.

Section 35 Establishing compliance with the essential requirements – non-prescribed measuring instruments

A manufacturer may demonstrate compliance with the essential requirements in respect of a non-prescribed measuring instrument in the same manner as a regulated measuring instrument and the requirements of Part 4 accordingly apply.

Section 36 Introductory

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

Section 37 Methods of establishing conformity with the essential requirements

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

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

(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 by the Secretary of State ; or

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

Section 38 Presumptions of conformity of regulated measuring instruments

(1) Regulated measuring instruments which are in conformity with 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) 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 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.

Section 39 Conformity assessment procedures

(1) Conformity assessment of a 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 regulated measuring instrument in Schedule 1C to 1J .

(2) 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.

Section 39A Power to amend Schedules 1C to 1J

(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.

Section 40 Capacity serving measures - accredited in house bodies

(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 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 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 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.

(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.

Section 41 Subsidiaries and contractors

(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.

Section 42 Fees

(1) 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 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 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.

Section 43 Application of this Chapter

The technical documentation required for the purposes of conformity assessment under these Regulations must satisfy the requirements of this Chapter.

Section 44 General requirements to be met by technical documentation

(1) The technical documentation must—

(a) render the design, manufacture and operation of the regulated measuring instrument intelligible; and

(b) permit an assessment of its conformity with the applicable requirements of these Regulations .

(2) The technical documentation must be sufficiently detailed to ensure compliance with the following requirements—

(a) the definition of the metrological characteristics;

(b) the reproducibility of the metrological performances of produced regulated measuring instruments when properly adjusted using appropriate intended means; and

(c) the integrity of the regulated measuring instrument.