Statutory Instruments

2016 No. 1153

Weights And Measures

The Measuring Instruments Regulations 2016

Made

29th November 2016

Laid before Parliament

6th December 2016

Coming into force

28th December 2016

The Secretary of State is a Minister designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to, and for purposes ancillary to, the regulation of specifications, construction, placing on the market and use of articles, instruments, containers or other equipment intended for weighing, measuring or testing.

These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to the Secretary of State that it is expedient for certain references to provisions of EU instruments to be construed as references to those provisions as amended from time to time.

The Secretary of State makes the following Regulations in exercise of the powers conferred by section 2(2) of, and paragraph 1A of Schedule 2 to that Act and, in relation to Part 6 of the Regulations (and any other provisions of these Regulations to the extent that they apply to, or give effect to, Part 6), in exercise of powers conferred by sections 15(1) and 86(1) of the Weights and Measures Act 1985 .

PART 1INTRODUCTORY

Citation, commencement and extent

1.—(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.

Interpretation

2.—(1) In these Regulations—

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

...

“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—

(a)

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

(b)

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—

(a)

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

(b)

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

(c)

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;

...

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

...

“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 regulatedmeasuring 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

...

“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 regulatedmeasuring 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—

(a)

an inspector; or

(b)

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 regulatedmeasuring 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 ;

...

“exhaust gas analyser” means a regulatedmeasuring 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—

(a)

carbon monoxide;

(b)

carbon dioxide;

(c)

oxygen; and

(d)

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;

...

“importer” means a person who—

(a)

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

(b)

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—

(a)

transmitted by electronic means;

(b)

received in legible form; and

(c)

capable of being used for subsequent reference;

“M marking” means a marking applied to a regulatedmeasuring 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;

...

“make available on the market” means any supply of a regulatedmeasuring 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—

(a)

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

(b)

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

“material measure” means—

(a)

a material measure of length; or

(b)

a capacity serving measure;

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

...

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

(a)

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

(b)

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;

...

“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 regulatedmeasuring 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 accreditation and market surveillance relating to the marketing of products and repealing Regulation

“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 regulatedmeasuring 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 regulatedmeasuring instrument, an economic operator with obligations in respect of that regulatedmeasuring instrument under Part 2;

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

...

“taximeter” means a device that works together with a signal generator to make a regulatedmeasuring 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 regulatedmeasuring instrument;

...

“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;

...

“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 regulatedmeasuring instrument, means taking any measure aimed at preventing a regulatedmeasuring 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 .

Interpretation

2.—(1) In these Regulations—

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

“accreditation” bears the same meaning as in point 10 of Article 2 of RAMS;

“accreditation certificate” means a certificate, issued by the United Kingdom Accreditation Service or a national accreditation body in another relevant state, attesting that a conformity assessment body meets the notified body requirements;

“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;

“authorised representative” means any person established within the relevant market 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—

(a)

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

(b)

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 discontinuous totaliser” means an automatic weighing instrument that—

(a)

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

(b)

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

(c)

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;

“CE marking” means a marking which takes the form set out in Annex II of RAMS;

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

“Commission” means the Commission of the European Union;

“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 measuring instrument have been met;

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

“dimensional measuring instrument” means—

(a)

a length measuring instrument that serves for the determination of the length of rope type materials (for example textiles, bands, cables) during feed motion of the product to be measured;

(b)

an area measuring instrument which serves for the determination of the area of irregular shaped objects, for example for leather; or

(c)

a multi-dimensional measuring instrument which serves for the determination of the edge length (length, height, width) of the smallest enclosing rectangular parallelepiped of a product;

“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 and references to the Directive (or a specific provision of it) are references to the Directive (or that provision) as from time to time amended;

“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 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—

(a)

an inspector; or

(b)

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 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 1;

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

“EU-design examination certificate” means an EU-design certificate issued by a notified body in accordance with Module H1 of Annex II to the Directive;

“EU-type examination certificate” means an EU-type examination certificate issued by a notified body in accordance with Module B of Annex II to the Directive;

“exhaust gas analyser” means a 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—

(a)

carbon monoxide;

(b)

carbon dioxide;

(c)

oxygen; and

(d)

hydrocarbons;

“harmonised standard” has the meaning set out in point 1(c) of Article 2 of Regulation (EU) 1025/2012 of the European Parliament and of the Council on European standardisation (as amended from time to time);

“importer” means any person who—

(a)

is established within the relevant market ; and

(b)

places a measuring instrument from a market outside of the relevant market on the relevant market;

“in writing” includes text that is—

(a)

transmitted by electronic means;

(b)

received in legible form; and

(c)

capable of being used for subsequent reference;

“M marking” means a marking applied to a 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 CE marking applied to that instrument;

“measuring instrument” has the meaning in regulation 3(1);

“make available on the market” means any supply of a measuring instrument for distribution, or use on the relevant market 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—

(a)

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

(b)

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) and where the context requires includes a market surveillance authority in another relevant state;

“material measure” means—

(a)

a material measure of length; or

(b)

a capacity serving measure;

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

“national accreditation body” means the national accreditation body as defined in point 11 of Article 2 of RAMS;

“NI Protocol obligation” means any obligation created or arising by or under the Protocol on Ireland/ Northern Ireland in the EU withdrawal agreement, whether or not an obligation to which section 7A(2) of the European Union (Withdrawal) Act 2018 applies;

“non-prescribed measuring instrument” means a measuring instrument of a kind referred to in regulation 3(3);

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

(a)

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

(b)

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

“notified body” means a conformity assessment body that has been notified to the Commission in accordance with Part 5 and includes, where the context so requires, a notified body designated as such in another relevant state in accordance with the Directive;

“notified body requirements” means the requirements set out in Schedule 5 (notified body requirements);

“notifying authority” means the notifying authority within the meaning of regulation 54 (the notifying authority)

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

“putting into use” means the first use of a 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 accreditation and market surveillance relating to the marketing of products and repealing Regulation

“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 measuring instrument, a conformity assessment procedure specified in Schedule 1 as being applicable to that instrument;

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

“relevant market” means—

(a)

the market in Northern Ireland; and

(b)

the market of the EEA states;

“relevant state” means—

(a)

Northern Ireland; or

(b)

any EEA state;

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

“sub-assembly” means a hardware device mentioned as such in the instrument-specific annexes to the Directive that functions independently and makes up a measuring instrument together with other sub-assemblies with which it is compatible, or with a measuring instrument with which it is compatible;

“taximeter” means a device that works together with a signal generator to make a 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 measuring instrument;

“thermal energy meter” means an instrument designed to measure the thermal energy which, in a thermal energy exchange circuit, is given up by a liquid called the thermal energy-conveying liquid which is intended for residential, commercial or light industrial use and includes the following sub-assemblies, flow sensors, temperature sensor pairs and calculators where these are manufactured separately;

“UK(NI) indication” means the marking in the form set out in Schedule 1 to the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020;

“Union harmonisation legislation” means any European Union legislation harmonising the conditions for the marketing of products;

“United Kingdom Accreditation Service” means the company limited by guarantee incorporated in England and Wales under number 3076190;

“volume conversion device” means a device fitted to a gas meter that automatically converts the quantity measured at metering conditions into a quantity at the specified conditions to which the measured quantity of fluid is converted;

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

(2) A regulated measuring instrument that meets the requirements of the Directive by virtue of the laws of another relevant state is to be treated as meeting the requirements of these Regulations (except any requirement of these Regulations for anything to be written in English) and references to a regulated measuring instrument being in conformity with these Regulations are to be construed accordingly.

(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 .

Designated standard

2A.—(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 bodyor 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 suchtechnical specifications adopted by the other recognised standardisation bodiesor 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.

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

3.—(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;

(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

3.—(1) In these Regulations the expression “measuring instruments” comprises the following—

(a)water meters;

(b)gas meters and sub-assemblies for inclusion in, or attachment to, gas meters in the form of volume conversion devices;

(c)active electrical energy meters;

(d)thermal energy meters and any of the following sub-assemblies—

(i)flow sensors;

(ii)temperature sensor pairs; and

(iii)calculators;

(e)non-water liquid measuring systems;

(f)automatic weighing instruments of the following kinds—

(i)automatic catchweighers;

(ii)automatic gravimetric filling instruments;

(iii)discontinuous totalisers;

(iv)beltweighers; and

(v)automatic rail weighbridges;

(g)taximeters;

(h)material measures;

(i)dimensional measuring instruments; and

(j)exhaust gas analysers.

(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;

(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—

(aa)liquefied petroleum gas; or

(bb)liquefied natural gas;

(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;

(3) In these Regulations “non-prescribed measuring instruments” are measuring instruments that are neither regulated measuring instruments nor measuring instruments referred to in paragraph (4) and Schedule 2.

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

Revocations and transitional and consequential provisions

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

Exception for trade fairs, exhibitions and demonstration

5. 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.

PART 2REGULATED MEASURING INSTRUMENTS – OBLIGATIONS OF ECONOMIC OPERATORS

CHAPTER 1OBLIGATIONS OF MANUFACTURERS AND PERSONS TO BE TREATED AS MANUFACTURERS

Introductory

6.—(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

7.—(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 adeclaration 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' responsibilities – design, conformity assessment and marking of regulated measuring instruments

7. 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 an EU declaration of conformity; and

(e)affixed to the instrument—

(i)the CE marking; and

(ii)the M marking.

Manufacturers – obligations in respect of records

8. A manufacturer must keep the technical documentation and the EUdeclaration 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

9.—(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 instrumentrecalls; and

(d)keep distributors informed of any monitoring undertaken by them.

Manufacturers' obligations to ensure continuing conformity with 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 harmonised 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 instrumentrecalls; 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.

10.—(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

11.—(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.

(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.

Manufacturers to mark contact details on regulated measuring instruments where possible

(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 in a language easily understood by end-users and market surveillance authorities and, in the case of regulated measuring instruments made available in Northern Ireland , they must be in English.

Documentation to accompany regulated measuring instruments

12.—(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 .

Documentation to accompany regulated measuring instruments

12.—(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 EU 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) Information supplied in accordance with this regulation must be in a language that can easily be understood by end-users and where the end users are in Northern Ireland , the information must be in English.

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

Action to be taken where regulated measuring instruments placed on the market are not in conformity with the essential requirements

13.—(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.

Action to be taken where regulated measuring instruments placed on the market are not in conformity with the essential requirements

(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 national authorities of the relevant states in which the instrument has been made available on the market to that effect giving details, in particular, of the non-compliance and of any corrective measures taken.

Provision of information to the competent authority

14.—(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

15.—(1) A manufacturer may, by a written mandate, appoint a person established in the United Kingdom as theirauthorised 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.

Use of authorised representatives by manufacturers

15.—(1) A manufacturer may, by a written mandate, appoint an 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 EU 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;

(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 2OBLIGATIONS OF IMPORTERS

Introductory

16. 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.

Introductory

16. This Chapter applies to the placing on the market or the putting into use of a regulated measuring instrument from a country outside the relevant market that is imported into Northern Ireland .

Ensuring compliance of regulated measuring instruments

17.—(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).

Ensuring compliance of regulated measuring instruments

17.—(1) An importer must only place compliant regulated measuring instruments on the market.

(2) An importer must ensure that—

(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 CE marking and the M marking;

(d)the regulated measuring instrument is accompanied by a copy of the EU declaration of conformity and the documents referred to in regulation 12 (documentation to accompany regulated measuring instruments); and

Importers duty to notify manufacturer and market surveillance authorities of non-compliant regulated measuring instruments that present a risk

18. 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

19.—(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.

Requirements to mark importers' details on regulated measuring instruments

(2) Where a regulated measuring instrument is too small or of too sensitive a composition to allow it to bear the information required by paragraph (1), such information must be marked on any packaging in which the instrument is supplied and on any accompanying documents.

(3) Any contact details required by this regulation must be in a language easily understood by end-users and market surveillance authorities and, in the case of regulated measuring instruments made available in Northern Ireland , they must be in English.

Importers' duty to ensure that regulated measuring instruments are accompanied by relevant documentation

20.—(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.

Importers' duty to ensure that regulated measuring instruments are accompanied by relevant documentation

20.—(1) An importer must ensure that regulated measuring instruments imported by that importer are, where relevant, accompanied by the following instructions and information in a language easily understood by end-users—

(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) Where the end users are in Northern Ireland , the instructions and information referred to in paragraph (1) must be in English.

Duty of importers to ensure proper conditions of storage and transport

21. 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.

22.—(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 instrumentrecalls; 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

23.—(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

24. 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 EUdeclaration 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

25.—(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 3OBLIGATIONS OF DISTRIBUTORS

Introductory

26. 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

27. 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

28.—(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 – verification obligations

28.—(1) The distributor must verify that the regulated measuring instrument bears the CE marking and the M marking.

(2) The distributor must verify that the regulated measuring instrument is accompanied by—

(a)a copy of the EU 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 in a language that can be easily understood by end-users and where those end users are in Northern Ireland must be in English.

Distributors not to make non-conforming regulated measuring instruments available on the market etc.

29.—(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

30. 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

31.—(1) This regulation applies where a distributor considers, or has reason to believe, that a regulated measuring instrumentmade 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

32.—(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 4IDENTIFICATION OF ECONOMIC OPERATORS

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).

Obligations which are met by complying with obligations in the Directive

33A.—(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

33B.—(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

33C.—(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—

(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

33D.—(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.

PART 3NON-PRESCRIBED MEASURING INSTRUMENTS

Introductory

34.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.

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

35.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.

PART 4CONFORMITY OF MEASURING INSTRUMENTS

CHAPTER 1ESTABLISHING COMPLIANCE WITH THE ESSENTIAL REQUIREMENTS

Introductory

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

Introductory

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.

Methods of establishing conformity with the essential requirements

37. Conformity with the essential requirements may be established in relation to a regulatedmeasuring 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.

Methods of establishing conformity with the essential requirements

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;

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

Presumptions of conformity of regulated measuring instruments

38.—(1)Regulatedmeasuring 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)Regulatedmeasuring 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.

Presumptions of conformity of measuring instruments

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.

Conformity assessment procedures

39.—(1)Conformity assessment of a regulatedmeasuring 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 regulatedmeasuring 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.

Conformity assessment procedures

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.

Power to amend Schedules 1C to 1J

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.

Capacity serving measures - accredited in house bodies

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 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 regulatedmeasuring 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 regulatedmeasuring 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.

Capacity serving measures - accredited in house bodies

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

(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;

(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.

Subsidiaries and contractors

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.

Subsidiaries and contractors

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.

Fees

42.—(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.

Fees

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.

CHAPTER 2REQUIREMENTS AS TO THE TECHNICAL DOCUMENTATION REQUIRED FOR THE PURPOSES OF CONFORMITY ASSESSMENT

Application of this Chapter

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

General requirements to be met by technical documentation

44.—(1) The technical documentation must—

(a)render the design, manufacture and operation of the regulatedmeasuring 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 regulatedmeasuring instruments when properly adjusted using appropriate intended means; and

(c)the integrity of the regulatedmeasuring instrument.

General requirements to be met by technical documentation

44.—(1) The technical documentation must—

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

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

(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 measuring instruments when properly adjusted using appropriate intended means; and

(c)the integrity of the measuring instrument.

Specific information to be included in technical documentation

45.—(1) The technical documentation must, insofar as relevant for assessment and identification of either the regulatedmeasuring instrument or its type (or both), include the following information—

(a)a general description of the regulatedmeasuring instrument;

(b)the conceptual design and manufacturing drawings and plans of components, sub-assemblies, circuits etc.;

(c)manufacturing procedures to ensure consistent production;

(d)if applicable, a description of the electronic devices with drawings, diagrams, flow diagrams of the logic and general software information explaining their characteristics and operation;

(e)descriptions and explanations necessary for the understanding of the information referred to in sub-paragraphs (b) to (d);

(f)a list of any designated standards and normative documents which have been applied in full or in part...;

(g)descriptions of the solutions adopted to meet the essential requirements where designated standards or normative documents have not been applied, including a list of other relevant technical specifications applied;

(h)results of design calculations, examinations etc.;

(i)the appropriate test results, where necessary to demonstrate that the type or regulatedmeasuring instruments or both comply with the following—

(i)the requirements of these Regulations under declared rated operating conditions and under specified environmental disturbances; and

(ii)the durability specifications for gas and watermeters as well as for liquids other than water; and

(j)the type examination certificates or ... design examinations certificates in respect of regulatedmeasuring instruments containing parts identical to those in the design.

(2) The manufacturer must specify where seals and markings have been applied.

(3) The manufacturer must indicate the conditions for compatibility with interfaces and sub-assemblies where relevant.

Specific information to be included in technical documentation

45.—(1) The technical documentation must, insofar as relevant for assessment and identification of either the measuring instrument or its type (or both), include the following information—

(a)a general description of the measuring instrument;

(b)the conceptual design and manufacturing drawings and plans of components, sub-assemblies, circuits etc.;

(c)manufacturing procedures to ensure consistent production;

(d)if applicable, a description of the electronic devices with drawings, diagrams, flow diagrams of the logic and general software information explaining their characteristics and operation;

(e)descriptions and explanations necessary for the understanding of the information referred to in sub-paragraphs (b) to (d);

(f)a list of any harmonised standards and normative documents which have been applied in full or in part, the references of which have been published in the Official Journal of the European Union;

(g)descriptions of the solutions adopted to meet the essential requirements where harmonised standards or normative documents have not been applied, including a list of other relevant technical specifications applied;

(h)results of design calculations, examinations etc.;

(i)the appropriate test results, where necessary to demonstrate that the type or measuring instruments or both comply with the following—

(i)the requirements of the Directive under declared rated operating conditions and under specified environmental disturbances; and

(ii)the durability specifications for gas, water and thermal-energy meters as well as for liquids other than water; and

(j)the EU-type examination certificates or EU design examinations certificates in respect of measuring instruments containing parts identical to those in the design.

(2) The manufacturer must specify where seals and markings have been applied.

(3) The manufacturer must indicate the conditions for compatibility with interfaces and sub-assemblies where relevant.

CHAPTER 3REQUIREMENTS RELATING TO EU DECLARATIONS OF CONFORMITY

Application of Chapter

46. This Chapter applies in relation to ... declarations of conformity made in relation to a regulatedmeasuring instrument for the purposes of these Regulations.

Application of Chapter

46. This Chapter applies in relation to EU declarations of conformity made in relation to a measuring instrument for the purposes of these Regulations.

Form and contents of ... declaration of conformity etc.

47.—(1) The ... declaration of conformity must—

(a)state that the fulfilment of the essential requirements has been demonstrated in relation to the measuring instrument;

(b)contain the elements specified in the relevant conformity assessment modules set out in Schedule 1B and be updated when appropriate;

(c)have the model structure set out in Schedule 1K .

(2) Where a regulated measuring instrument is placed or made available on the market in the United Kingdom, the ... declaration of conformity in relation to the instrument must be in English.

Form and contents of EU declaration of conformity etc.

47.—(1) The EU declaration of conformity must—

(a)state that the fulfilment of the essential requirements has been demonstrated in relation to the measuring instrument;

(b)contain the elements specified in the relevant conformity assessment modules set out in Annex II to the Directive and be updated when appropriate;

(c)have the model structure set out in Annex XIII to the Directive.

(2) Where a regulated measuring instrument is placed or made available on the market in Northern Ireland , the EU declaration of conformity in relation to the instrument must be in English.

Regulated measuring instruments that require more than one declaration of conformity

48.Where a regulated measuring instrument is subject to more than one enactment requiring the drawing up of a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment by its title.

Measuring instruments that require more than one declaration of conformity

48.—(1) This regulation applies where a measuring instrument is subject to an NI Protocol obligation for an EU declaration of conformity otherwise than by virtue of these Regulations.

(2) Where this regulation applies, a single EU declaration of conformity must be drawn up covering all applicable requirements which identifies the relevant Union acts concerned including their publication references.

Responsibility of manufacturer that draws up declaration of conformity

49. A manufacturer, who draws up adeclaration of conformity in relation to a regulatedmeasuring instrument, is responsible for compliance of the measuring instrument with the requirements of these Regulations.

Responsibility of manufacturer that draws up declaration of conformity

49. A manufacturer, who draws up an EU declaration of conformity in relation to a measuring instrument, is responsible for compliance of the measuring instrument with the requirements of these Regulations.

CHAPTER 4CONFORMITY MARKING

Conformity with ... requirements to be indicated by the UK marking

50. The conformity of a measuring instrument with the requirements of these Regulations must be indicated by the presence on it of the UK marking and the M marking.

Conformity with Directive requirements to be indicated by the CE marking

50. The conformity of a measuring instrument with the requirements of these Regulations must be indicated by the presence on it of the CE marking and the M marking.

Prohibition on improper use of the UK marking and the M marking

51.—(1) An economic operator must not affix the UK marking or the M marking to a regulated measuring instrument unless—

(a)that economic operator is the manufacturer of the regulated measuring instrument; and

(b)the conformity of the regulated measuring instrument with the essential requirements has been demonstrated by a relevant conformity assessment procedure.

(2)An economic operator must not affix a marking to a regulated measuring instrument which is not the UK marking or the M marking but which purports to attest that the regulated measuring instrument satisfies the essential requirements.

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

(4)An economic operator must not affix to a regulated measuring instrument any other marking if the visibility, legibility and meaning of the UK marking or the M marking would be impaired as a result.

General principles relating to the M marking

51. The general principles set out in article 30 of RAMS apply to the M marking with such modifications as are necessary in the circumstances.

Rules and conditions for affixing the UK marking and the M marking

52.—(1) The UKmarking and the M marking (“the markings”) must be affixed to a regulatedmeasuring instrument in accordance with the provisions of this regulation.

(2) The markings must be affixed visibly, legibly and indelibly to the regulatedmeasuring instrument, its data plate, or where regulation 7(2) applies, to a label affixed to the regulatedmeasuring instrument or to a document accompanying the regulatedmeasuring instrument .

(3) Paragraph (2) does not apply where it is not possible or not warranted on account of the nature of the regulatedmeasuring instrument, in which case the markings must be affixed to the documents which accompany the regulatedmeasuring instrument and any packaging.

(4) When a regulatedmeasuring instrument consists of a series of devices..., operating together, the markings must be affixed on the instrument's main device.

(5) The markings must be affixed before the regulatedmeasuring instrument is placed on the market.

(6) The markings may be affixed to the regulatedmeasuring instrument during the fabrication process, if justified.

(7) The M marking must immediately follow the UKmarking.

(8) The markings must immediately be followed by the identification number of the approved body where that body is involved in the production control phase as set out in Schedule 1B .

(9) The identification number of the approved body referred to in paragraph (8) must—

(a)be affixed by the body itself, or under its instructions by the manufacturer or his authorised representative; and

(b)be indelible or self-destructive upon removal.

(10) The markings and (where applicable) the identification number of the approved body may be followed by any other mark indicating a special risk or use.

Rules and conditions for affixing the CE marking and the M marking

52.—(1) The CE marking and the M marking (“the markings”) must be affixed to a measuring instrument in accordance with the provisions of this regulation.

(2) The markings must be affixed visibly, legibly and indelibly to the measuring instrument or its data plate.

(3) Paragraph (2) does not apply where it is not possible or not warranted on account of the nature of the measuring instrument, in which case the markings must be affixed to the documents which accompany the measuring instrument and any packaging.

(4) When a measuring instrument consists of a series of devices, not being sub-assemblies, operating together, the markings must be affixed on the instrument's main device.

(5) The markings must be affixed before the measuring instrument is placed on the market.

(6) The markings may be affixed to the measuring instrument during the fabrication process, if justified.

(7) The M marking must immediately follow the CE marking.

(8) The markings must immediately be followed by the identification number of the notified body where that body is involved in the production control phase as set out in Annex II to the Directive.

(9) The identification number of the notified body referred to in paragraph (8) must—

(a)be affixed by the body itself, or under its instructions by the manufacturer or his authorised representative; and

(b)be indelible or self-destructive upon removal.

(10) The markings and (where applicable) the identification number of the notified body may be followed by any other mark indicating a special risk or use.

UK(NI) indication

52A.—(1)Where the CE marking is affixed on the basis of an assessment or a certificate issued by a notified body established in the United Kingdom, a UK(NI) indication must be affixed in relation to the regulated measuring instrument, in accordance with this regulation.

(2)The UK(NI) indication must be affixed—

(a)visibly, legibly and indelibly; and

(b)before the regulated measuring instrument is placed on the market in Northern Ireland.

(3)The UK(NI) indication must accompany the CE marking, wherever that is affixed in accordance with regulation 52.

(4)The UK(NI) indication must be affixed by—

(a)the manufacturer; or

(b)the manufacturer's authorised representative.

(5)When placing a regulated measuring instrument on the market in Northern Ireland, an importer must ensure that the manufacturer has complied with their obligations under this regulation.

Register of notified bodies established in the United Kingdom

52B.—(1)The Secretary of State must ensure that—

(a)each notified body established in the United Kingdom is assigned an identification number; and

(b)there is a register of—

(i)notified bodies established in the United Kingdom;

(ii)their notified body identification number;

(iii)the activities for which they have been notified;

(iv)any restrictions on those activities.

(2)The Secretary of State must ensure that the register referred to in paragraph (1) is maintained and made publicly available.

(3)The Secretary of State may authorise the United Kingdom Accreditation Service to compile and maintain the register in accordance with paragraph (1)(b).

PART 5APPROVAL OF CONFORMITY ASSESSMENT BODIESNOTIFICATION OF CONFORMITY ASSESSMENT BODIES

Approved bodies

53.—(1)An approved body is a conformity assessment body which—

(a)has been approved by the Secretary of State pursuant to the procedure set out in regulation 54 (approval of conformity assessment bodies); or

(b)immediately before IP completion day was a notified body in respect of which the Secretary of State had taken no action under regulation 60(1) or (2) as they had effect immediately before IP completion day to suspend or withdraw the body's status as a notified body.

(2)Paragraph (1) has effect subject to regulation 57 (restriction, suspension or withdrawal of approval).

(3)In this Part—

“notified body” means a body—

(a)

which the Secretary of State had before IP completion day notified to the European Commission and the member States of the European Union, in accordance with Article 23 of the Directive; and

(b)

in respect of which no objections had been raised, as referred to in regulation 53(2)(b), as it had effect immediately before IP completion day;

“approved body requirements” means the requirements set out in Schedule 5.

Introductory

53.—(1) This Part applies to the notification to the Commission and other relevant states of the bodies authorised to carry out conformity assessment procedures in the United Kingdom in relation to measuring instruments.

(2) For the purposes of this Part, a notified body is a conformity assessment body—

(a)which has been notified to the Commission and to other relevant states under regulation 55 (notification); and

(b)in respect of which no objections , other than an immaterial objection, are raised by the Commission or other relevant states—

(i)within 2 weeks of a notification, where an accreditation certificate is used; or

(ii)within 2 months of a notification, where accreditation is not used;

(c)in sub-paragraph (b), an “immaterial objection” is an objection on the grounds that—

(i)the conformity assessment body is established in the United Kingdom; or

(ii)the accreditation certificate was issued by the United Kingdom Accreditation Service.

(3) Paragraph (2) has effect subject to regulation 60 (changes to notifications).

Approval of conformity assessment bodies

54.—(1)The Secretary of State may approve only those conformity assessment bodies that qualify for approval.

(2)A conformity assessment body qualifies for approval if the first and second conditions below are met.

(3)The first condition is that the conformity assessment body has applied to the Secretary of State to become an approved body and that application is accompanied by—

(a)a description of—

(i)the conformity assessment activities that the conformity assessment body intends to carry out;

(ii)the conformity assessment procedure in respect of which the conformity assessment body claims to be competent; and

(iii)the regulated measuring instrument for which the conformity assessment body claims to be competent; and

(b)either—

(i)an accreditation certificate; or

(ii)the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body's compliance with the approved body requirements.

(4)The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements.

(5)For the purposes of paragraph (4), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (3)(b)(i), as sufficient evidence that the conformity assessment body meets the approved body requirements.

(6)When deciding whether to approve a conformity assessment body that qualifies for approval, the Secretary of State may–

(a)have regard to any other matter which appears to the Secretary of State to be relevant; and

(b)set conditions that the conformity assessment body must meet.

(7)For the purposes of this regulation “accreditation certificate” means a certificate, issued by the UK national accreditation body, attesting that a conformity assessment body meets the approved body requirements.

The notifying authority

54.—(1) The notifying authority for the purposes of these Regulations is the Secretary of State.

(2) The functions of the notifying authority are—

(a)to assess whether applicants for recognition as conformity assessment bodies meet the requirements for recognition as such;

(b)where an assessment that a body is qualified to act as a conformity assessment body is made, to notify the Commission of that fact; and

(c)to carry out such monitoring of bodies notified to the Commission to ensure continuing compliance with the requirements of these Regulations.

(3) The notifying authority may delegate the performance of its functions to a body that meets the requirements of Articles 24(3) and 25 of the Directive but in the event of such a delegation the notifying authority remains fully responsible for the performance of those functions.

(4) The notifying authority must supply such information as the Commission may request in relation to a body notified by it.

Presumption of conformity of approved bodies

55.—(1)Where a conformity assessment body demonstrates its conformity with the criteria laid down in a designated standard (or part of such standard), the Secretary of State is to presume that the conformity assessment body meets the approved body requirements covered by that standard (or that part of that standard).

(2)The presumption in paragraph (1) is rebuttable.

Notification

55.—(1) The Secretary of State may notify to the Commission and the other relevant states only those conformity assessment bodies that qualify for notification.

(2) A conformity assessment body qualifies for notification if the first and the second conditions below are met.

(3) The first condition is that the conformity assessment body makes an application to the Secretary of State for notification and that application is accompanied by—

(a)a description of—

(i)the conformity assessment activities that the conformity assessment body intends to carry out;

(ii)the conformity assessment module for which the conformity assessment body claims to be competent; and

(iii)the measuring instrument for which the conformity assessment body claims to be competent; and either

(b)an accreditation certificate; or

(c)the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body's compliance with the notified body requirements.

(4) The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the requirements of Schedule 5 (“the notified body requirements”).

(5) For the purposes of paragraph (4), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (3)(b), as sufficient evidence that the conformity assessment body meets the notified body requirements.

(6) When deciding whether to notify a conformity assessment body that qualifies for notification to the Commission and the other relevant states, the Secretary of State may—

(a)have regard to any other matter which appears to the Secretary of State to be relevant; and

(b)set conditions that the conformity assessment body must meet.

(7) The Secretary of State must inform the Commission of the United Kingdom's procedures for the assessment and notification of conformity assessment bodies, and any changes to those procedures.

Monitoring

56.The Secretary of State must monitor each approved body with a view to verifying that the body—

(a)continues to meet the approved body requirements;

(b)meets any conditions set—

(i)in accordance with regulation 54(6)(b); or

(ii)in the case of an approved body which was a notified body immediately before IP completion day, in accordance with regulation 54(6)(b) as it applied immediately before IP completion day; and

(c)carries out its functions in accordance with these Regulations.

Presumption of conformity of notified bodies

56.—(1) Where a conformity assessment body demonstrates its conformity with the criteria laid down in a harmonised standard (or part of such a standard), the reference of which has been published in the Official Journal of the European Union, the Secretary of State is to presume that the conformity assessment body meets the notified body requirements covered by that standard (or part of that standard).

(2) The presumption in paragraph (1) is rebuttable.

Restriction, suspension or withdrawal of approval

57.—(1)Where the Secretary of State determines that an approved body—

(a)no longer meets an approved body requirement, or

(b)is failing to fulfil its obligations under these Regulations, other than a condition referred to in regulation 54(6)(b),

the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under regulation 54 (approval of conformity assessment bodies).

(2)With the consent of an approved body, or where the Secretary of State determines that an approved body no longer meets a condition referred to in regulation 56(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under regulation 54 (approval of conformity assessment bodies).

(3)In deciding what action is required under paragraph (1) or (2), the Secretary of State must have regard to the seriousness of the non-compliance.

(4)Before taking action under paragraph (1) or (2), the Secretary of State must—

(a)give notice in writing to the approved body of the proposed action and the reasons for it;

(b)give the approved body an opportunity to make representations to the Secretary of State regarding the proposed action within a reasonable period from the date of the notice; and

(c)consider any such representations made by the approved body.

(5)Where the Secretary of State has taken action in respect of an approved body under paragraph (1) or (2), or where an approved body has ceased its activity, the approved body must—

(a)on the request of the Secretary of State, transfer its files relating to the activities it has undertaken as an approved body to another approved body or to the Secretary of State; or

(b)in the absence of a request under sub-paragraph (a), ensure that its files relating to the activities it has undertaken as an approved body are kept available for the Secretary of State and competent authorities for a period of 10 years from the date they were created.

(6)The activities undertaken as an approved body referred to in paragraph (5) include any activities that the body has undertaken as a notified body.

(7)The Secretary of State may impose a monetary penalty on an approved body that fails to comply with any requirement imposed by or under paragraph (5).

(8)Schedule 7 has effect in relation to a monetary penalty imposed under paragraph (7).

Contents of notification

57. A notification under regulation 55 (notification) must include—

(a)details of—

(i)the conformity assessment activities in respect of which the conformity assessment body has made its application for notification;

(ii)the conformity assessment module in respect of which the conformity assessment body has made its application for notification;

(iii)the measuring instrument in respect of which the conformity assessment body has made its application for notification; and either

(b)an accreditation certificate; or

(c)documentary evidence which attests to—

(i)the conformity assessment body's competence; and

(ii)the arrangements in place to ensure that the conformity assessment body will be monitored regularly and will continue to meet the notified body requirements.

Register of approved bodies

58.—(1)The Secretary of State must—

(a)assign an approved body identification number to each approved body; and

(b)compile and maintain a register of—

(i)approved bodies;

(ii)their approved body identification numbers;

(iii)the activities for which they have been approved; and

(iv)any restrictions on those activities.

(2)The register referred to in paragraph (1) must be made publicly available.

Monitoring

58.—(1) The Secretary of State must monitor each notified body with a view to verifying that the notified body—

(a)continues to meet the notified body requirements;

(b)meets any conditions set in accordance with regulation 55(6)(b); and

(c)carries out its functions in accordance with these Regulations.

(2) The Secretary of State must inform the Commission of the United Kingdom's procedures for the monitoring of notified bodies, and any changes to those procedures.

UK national accreditation body

59.—(1)The Secretary of State may authorise the UK national accreditation body to carry out the following activities on behalf of the Secretary of State—

(a)assessing whether a conformity assessment body meets the approved body requirements; and

(b)monitoring approved bodies in accordance with regulation 56;

(2)Where the Secretary of State authorises the UK national accreditation body pursuant to paragraph (1), the Secretary of State remains fully responsible for anything done pursuant to that authorisation.

Delegation to the United Kingdom Accreditation Service

59. The Secretary of State may authorise the United Kingdom Accreditation Service to carry out the following activities on behalf of the Secretary of State—

(a)assessing whether a conformity assessment body meets the notified body requirements; and

(b)monitoring notified bodies.

(2) Where the Secretary of State authorises the United Kingdom Accreditation Service pursuant to paragraph (1), the Secretary of State remains fully responsible for anything done pursuant to that authorisation.

Changes to notifications

60. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Changes to notifications

60.—(1) Where the Secretary of State determines that a notified body no longer meets a notified body requirement, or that it is failing to fulfil any of its obligations under these Regulations other than conditions set in accordance with regulation 55(6)(b), the Secretary of State must restrict, suspend or withdraw the body's status as a notified body under regulation 55 (notification).

(2) With the consent of a notified body, or where the Secretary of State determines that a notified body no longer meets a condition set in accordance with regulation 55(6)(b), the Secretary of State may restrict, suspend or withdraw the body's status as a notified body under regulation 55.

(3) In deciding what action is required under paragraph (1) or (2), the Secretary of State must have regard to the seriousness of the failure.

(4) Before taking action under paragraph (1) or (2), the Secretary of State must—

(a)give notice in writing that the Secretary of State intends to take such action and the reasons for taking such action; and

(b)give the notified body an opportunity to make representations within a reasonable period from the date of that notice and consider any such representations.

(5) Where the Secretary of State takes action under paragraph (1) or (2), the Secretary of State must immediately inform the Commission and the other relevant states.

(6) Where the Secretary of State has taken action in respect of a notified body under paragraph (1) or (2), or where a notified body has ceased its activity, the body must—

(a)on the request of the Secretary of State, transfer its files to another notified body or to the Secretary of State; or

(b)in the absence of a request under sub-paragraph (a), ensure that its files are kept available for the Secretary of State and each enforcing authority for such period as the Secretary of State may specify.

(7) The Secretary of State may impose a monetary penalty on a United Kingdom notified body that fails to comply with any requirement imposed by or under paragraph (6).

(8) Schedule 7 has effect in relation to a monetary penalty imposed under paragraph (7)

PART 6USE FOR TRADE OF CERTAIN REGULATED MEASURING INSTRUMENTS

61. The use for trade of the following equipment must comply with the requirements of Schedule 6—

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

(b)measuring systems which are 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—

(i)liquefied petroleum gas; or

(ii)liquefied natural gas;

(c)measuring systems (other than one used in connection with the refuelling of aircraft, ships or hovercraft) which are 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—

(i)liquefied gases;

(ii)lubricating oils;

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

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

(d)automatic catchweighers;

(e)automatic gravimetric filling instruments;;

(f)automatic discontinuous totalisers;

(g)automatic rail weighbridges;

(h)beltweighers;

(i)material measures of length; and

(j)capacity serving measures.

PART 7MARKET SURVEILLANCE AND ENFORCEMENT

CHAPTER 1MARKET SURVEILLANCE

The market surveillance authority

62. The Secretary of State is the market surveillance authority for the purposes of these Regulations and RAMS.

Regulated measuring instruments presenting a risk

63.—(1) This regulation applies where the market surveillance authority has sufficient reason to believe that a regulated measuring instrument presents a risk on grounds of public interest, public health, public safety, public order, protection of the environment, protection of consumers, the levying of taxes and duties or fair trading.

(2) Where this regulation applies the market surveillance authority must carry out an evaluation of the regulated measuring instrument covering all relevant requirements of these Regulations which apply to that instrument.

(3) The relevant economic operators in relation to the regulated measuring instrument must co-operate as necessary with the market surveillance authority for that purpose.

(4) Where in the course of the evaluation referred to in paragraph (2), the market surveillance authority finds that the regulated measuring instrument does not comply with the essential requirements applicable to it, it must without delay issue a direction which requires the relevant economic operator to—

(a)take all appropriate corrective actions;

(b)withdraw the instrument from the market; or

(c)recall it within a reasonable period commensurate with the nature of the risk.

(5) Where the market surveillance authority acts under paragraph (4), it must without delay inform the approved body that carried out the conformity assessment procedure in respect of the regulated measuring instrument of—

(a)the respect in which the instrument is not in conformity with the requirements of these Regulations; and

(b)the actions that the authority is requiring the relevant economic operator to take.

(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7) The economic operator must ensure that all appropriate corrective action is taken in respect of all the regulated measuring instruments concerned that it has made available in the United Kingdom .

(8) Where the relevant economic operator does not take adequate corrective action within a reasonable period, the market surveillance authority must take all provisional measures to prohibit or restrict the regulated measuring instrument being made available on the market, to withdraw the instrument from the market or to recall it.

(9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(10) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Regulated measuring instruments presenting a risk

(3) The relevant economic operators in relation to the regulated measuring instrument must co-operate as necessary with the market surveillance authority for that purpose.

(a)take all appropriate corrective actions;

(b)withdraw the instrument from the market; or

(c)recall it within a reasonable period commensurate with the nature of the risk.

(5) Where the market surveillance authority acts under paragraph (4), it must without delay inform the notified body that carried out the conformity assessment procedure in respect of the regulated measuring instrument of—

(a)the respect in which the instrument is not in conformity with the requirements of these Regulations; and

(b)the actions that the authority is requiring the relevant economic operator to take.

(6)Subject to paragraph (6A), where the market surveillance authority considers that non-compliance is not restricted to Northern Ireland , it must inform the Commission and the other relevant states of the results of the evaluation and of the actions which they have required the economic operator to take.

(6A)Paragraph (6) does not require the Secretary of State to inform the Commission or the other relevant states where the non-compliance extends only to any of England or Wales or Scotland.

(8) Where the relevant economic operator does not take adequate corrective action within a reasonable period, the market surveillance authority must take all provisional measures to prohibit or restrict the regulated measuring instrument being made available on the market in Northern Ireland , to withdraw the instrument from the market in Northern Ireland or to recall it.

(9) Where the market surveillance authority takes measures under paragraph (8), the market surveillance authority must notify the Commission and the other relevant states of those measures without delay.

(10) A notification under paragraph (9) must include all available details, in particular—

(a)the data necessary for the identification of the non-compliant regulated measuring instrument;

(b)the origin of the instrument;

(c)the nature of the non-compliance alleged and the risk involved;

(d)the nature and duration of the measures taken;

(e)the arguments put forward by the relevant economic operator; and

(f)whether the non-compliance is due to either of the following—

(i)failure of the regulated measuring instrument to meet the requirements relating to a risk;

(ii)shortcomings in the harmonised standards referred to in regulation 37(a).

EU safeguard procedure

64.—(1)Where another relevant state has initiated the procedure under Article 42 of the Directive, the Market surveillance authority must without delay, inform the Commission and the other relevant states of—

(a)any measures taken by a competent authority in respect of the regulated measuring instrument;

(b)any additional information which the market surveillance authority has at its disposal relating to the lack of conformity of the regulated measuring instrument.

(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2)Where a measure taken by another relevant state in respect of a regulated measuring instrument is considered justified under Article 42 of the Directive, the market surveillance authority must ensure that appropriate measures to withdraw the instrument are taken in respect of the regulated measuring instrument without delay.

(3)If, pursuant to Article 43 of the Directive, the Commission considers a direction given pursuant to regulation 63(4) is unjustified, the market surveillance authority must forthwith withdraw it and notify other enforcement authorities and economic operators affected accordingly.

Compliant regulated measuring instruments which present a risk

65.—(1) This regulation applies where, having carried out an evaluation under regulation 63, the market surveillance authority finds that although a regulated measuring instrument is in compliance with the requirements of these Regulations, it presents a risk on grounds of public interest, public health, public safety, public order, protection of the environment, protection of consumers, the levying of taxes and duties or fair trading.

(2) Where this regulation applies, the market surveillance authority must issue a direction requiring the economic operator to—

(a)take all appropriate measures to ensure that the regulated measuring instrument concerned, when placed on the market, no longer presents that risk;

(b)withdraw the regulated measuring instrument from the market; or

(c)recall it within a reasonable period, commensurate with the nature of the risk as it may prescribe.

(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Compliant regulated measuring instruments which present a risk

(2) Where this regulation applies, the market surveillance authority must issue a direction requiring the economic operator to—

(a)take all appropriate measures to ensure that the regulated measuring instrument concerned, when placed on the market, no longer presents that risk;

(b)withdraw the regulated measuring instrument from the market in Northern Ireland ; or

(c)recall it within a reasonable period, commensurate with the nature of the risk as it may prescribe.

(3) Where this regulation applies, the market surveillance authority must immediately inform the Commission and the other relevant states of all available details including—

(a)the data necessary for the identification of the regulated measuring instrument concerned;

(b)the origin and supply chain of the regulated measuring instrument;

(c)the nature of the risk involved; and

(d)the nature and duration of the national measures taken.

Provisions as to directions under regulations 63 and 65

66.—(1) This regulation applies in relation to directions given under regulations 63 and 65.

(2) A direction must—

(a)be in writing;

(b)describe the regulated measuring instrument to which it relates in a manner sufficient to identify that instrument;

(c)specify the risk identified by the market surveillance authority;

(d)specify the steps that the economic operator must take (including the time period within which they must be taken).

(3) The Secretary of State may impose a monetary penalty on an economic operator who fails to comply with a direction given under regulation 63 or 65.

(4) Schedule 7 has effect in relation to a monetary penalty imposed under paragraph (3).

CHAPTER 2ENFORCEMENT AUTHORITIES AND PROCEDURES

Enforcement of the Regulations

67.—(1) The Secretary of State—

(a)must enforce these regulations where required to do so in the capacity of the market surveillance authority; and

(b)may otherwise than in the capacity of market surveillance authority, enforce these Regulations in Great Britain,

and for the purposes of this paragraph may appoint a person to act on his behalf.

(2) In Great Britain it is the duty of every local weights and measures authority to enforce these Regulations within its area in relation to regulated measuring instruments other than—

(a)gas meters;

(b)active electrical energy meters;

(c)taximeters; and

(d)exhaust gas analysers.

(3) In Northern Ireland—

(a)the Department for Infrastructure must enforce these Regulations in relation to regulated measuring instruments of the following kinds—

(i)taximeters; and

(ii)exhaust gas analysers.

(b)the Utility Regulator (or the Secretary of State pursuant to arrangements made under paragraph (7)) must enforce the Regulations) in relation to regulated measuring instruments of the following kinds—

(i)gas meters; and

(ii)active electrical energy meters.

(c)the Department for the Economy must enforce these Regulations (other than Part 6) insofar as they relate to regulated measuring instruments of the following kinds—

(i)cold water meters;

(ii)automatic weighing instruments;

(iii)material measures; and

(iv)non-water liquid measuring systems.

(4) No proceedings for an offence under these Regulations may be instituted in England and Wales except by or on behalf of a competent authority.

(5) Nothing in these Regulations shall authorise a competent authority to bring proceedings in Scotland for an offence.

(6) No proceedings shall be instituted in Northern Ireland for an offence under these Regulations in respect of a regulated measuring instrument except—

(a)by or on behalf of a competent authority which has responsibility for enforcing these Regulations in respect of that regulated measuring instrument; or

(b)the Director of Public Prosecutions for Northern Ireland.

(7) The Secretary of State and the Utility Regulator may, in relation to the enforcement of these Regulations in Northern Ireland, enter into arrangements for the Secretary of State to act on behalf of the Utility Regulator for, or in connection with, the carrying out of some or all of the functions conferred on the Utility Regulator by these Regulations.

Compliance notice procedure

68.—(1) This regulation applies where a competent authority has reasonable grounds for considering that one or more of the following breaches applies in relation to a regulated measuring instrument that has been placed on the market or put into use—

(a)the UK marking or the M marking has been affixed in violation of regulation 51 or regulation 52 ;

(b)the UK marking or the M marking has not been affixed;

(c)the identification number of the approved body, where the approved body is involved in the production control phase has—

(i)been affixed otherwise than in accordance with the requirements of these Regulations; or

(ii)not been affixed;

(d)the ... declaration of conformity has not been drawn up correctly;

(e)the technical documentation is either not available or is not complete;

(f)the information referred to in regulation 11 or regulation 20 is false or incomplete; or

(g)any other failure—

(i)by a manufacturer to comply with the requirements of Chapter 1 of Part 2; or

(ii)by an importer to comply with the requirements of Chapter 2 of Part 2.

(2) The competent authority may serve a notice in writing (“a compliance notice”) on the economic operator it considers is the responsible for the breach which must—

(a)describe the regulated measuring instrument to which it relates in a manner sufficient to identify that instrument;

(b)specify which of the circumstances in paragraph (1) applies in relation to the regulated measuring instrument;

(c)require the economic operator on whom the notice is served to take steps to remedy the matters referred to in paragraph (b);

(d)specify the date, being not less than 21 days from the date of the notice, by which the steps specified in it must be taken; and

(e)warn the economic operator that, where the non-conformity continues beyond the date specified in sub-paragraph (d), the competent authority may take further action under regulation 69 (enforcement notices) in respect of that regulated measuring instrument.

(3) Where a compliance notice is served by a competent authority other than the Secretary of State, it must at the same time as it serves that notice, send a copy to the Secretary of State.

Compliance notice procedure

(a)the CE marking or the M marking has been affixed in violation of Article 30 of the RAMS regulation or the requirements of these Regulations;

(b)the CE marking or the M marking has not been affixed;

(c)the identification number of the notified body, where the notified body is involved in the production control phase has—

(i)been affixed otherwise than in accordance with the requirements of these Regulations; or

(ii)not been affixed;

(ca)the UK(NI) indication—

(i)has not been affixed, in contravention of regulation 52A; or

(ii)has been affixed other than in accordance with regulation 52A;

(d)the EU declaration of conformity has not been drawn up correctly;