Statutory guidance

Measuring Instruments Regulations 2016: Great Britain

Updated 5 December 2024

Guidance on the regulations as they apply to measuring instruments being supplied in or into Great Britain.

This guidance has been amended to reflect the announcements on 1 August 2023 and 24 January 2024 that the Government is extending recognition of certain goods that meet EU requirements (including the CE marking), indefinitely, beyond 2024 for many products. The Product Safety and Metrology etc. (Amendment) Regulations 2024 give effect to this and came into force on 1 October 2024.

December 2024

1. Introduction

This Guide is for businesses placing measuring instruments on the market in Great Britain (“GB”). If you are placing measuring instruments on the market in Northern Ireland (“NI), you should read separate guidance.

Read guidance on the regulations in NI.

This Guide is designed to help you comply with the Measuring Instrument Regulations 2016, as they apply in GB (referred to in this document as “the 2016 Regulations”). The 2016 Regulations set out the requirements that must be met before measuring instruments can be placed on the GB market. The purpose of the legislation is to protect business and consumers from inaccurate measuring instruments by requiring manufacturers to show how their instruments meet the ‘essential requirements’.

2. Legislative Background

The 2016 Regulations implemented Directive 2014/32/EU on measuring instruments and replaced fifteen individual regulations (including non-prescribed instruments) with one single regulation.

The EU Withdrawal Act 2018 preserved the 2016 Regulations and enabled them to be amended so as to continue to function effectively now the UK has left the EU. Accordingly, the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 fixed any deficiencies that arose from the UK leaving the EU (such as references to EU institutions) and made specific provision for the GB market.

There is therefore one set of UK 2016 Regulations, but some of the provisions apply differently in NI under the terms of the Windsor Framework. References to the 2016 Regulations in this guidance are references to those Regulations as they apply in GB.

The following legislative amendments and Government announcements apply:

• The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 were amended by the Product Safety and Metrology etc. (Amendment to Extent and Meaning of Market) (EU Exit) Regulations 2020 to apply to GB only, and not to NI, in support of implementing The Protocol of Ireland and Northern Ireland (“The Northern Ireland Protocol”) and now the Windsor Framework.
• The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 were further amended by the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 to provide for a 24 month transition period for importer labelling (for goods from the EEA), UKCA marking, to amend the definition of “authorised representative” as well as introducing an end (in 12 months from the end of the Transition Period) to the recognition of goods meeting EU requirements, as well as introducing provisions for qualifying NI goods.
• On 24 August 2021 the Government announced the transition period for UKCA marking would be extended until 31 December 2022. The Product Safety and Metrology etc (Amendment) Regulations 2021 gave effect to this. On 14 November 2022 the Government announced it would be extending this until 31 December 2024. The Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022 (SI 2022/1393) gave effect to this.
• On 20 June 2022, the Government announced the provisions for UKCA labelling and importer labelling would be extended until 31 December 2025. On 14 November 2022 the Government announced it would be extending the provisions for UKCA labelling and importer labelling until 31 December 2027. The Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022 (SI 2022/1393) give effect to this.
• On 1 August 2023 and 24 January 2024, the UK Government announced it would extend recognition of goods that meet EU requirements (including the CE marking), indefinitely, beyond 2024 for many products. This means that certain goods that meet EU requirements can be placed on the GB market beyond 31 December 2024. The Product Safety and Metrology etc. (Amendment) Regulations 2024 give effect to this and came into force on 1 October 2024. The legislation also provides for a ‘Fast-Track’ UKCA scheme, whereby steps taken towards CE marking will count towards UKCA marking, while UK product safety regulations remain aligned with EU product safety law.

Read guidance on the regulations in NI.

3. Scope

The Regulations regulate ^{[footnote 1]} the following kinds of measuring instruments:

• water meters used for trade for the supply of potable water in the temperature range from 0.1°C to and including 30°C
• 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 metres an hour (or the equivalent quantity in kilograms)

• 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:

  • the maximum quantity supplied exceeds 100 kilowatts per hour
  • the instrument provides measurement on a half-hourly basis

• non-water liquid measuring systems for use for trade of the following descriptions:

  • 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:

    • liquefied petroleum gas, or
    • liquefied natural gas

  • 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:

    • liquefied gases
    • lubricating oils
    • liquid fuels of a temperature below -153°C, or
    • liquid fuels of a dynamic viscosity exceeding 100 millipascal seconds at 15°C

• automatic weighing instruments of the following kinds which are for use for trade:

  • automatic catchweighers
  • automatic gravimetric filling instruments
  • discontinuous totalisers
  • beltweighers, and
  • automatic rail weighbridges
• taximeters intended for use for the protection of consumers;

• material measures which are for use for trade of the following kinds:

  • material measures of length (excluding dipping and strapping tapes);
  • 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;
  • capacity serving measures for the measurement of liquids other than draught 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;
• 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

The 2016 Regulations do not apply to putting into use of the instruments listed in Schedule 2.

4. Obligations of manufacturers

A manufacturer is a person who manufactures measuring instruments, or has measuring instruments designed or manufactured or modified, and markets those measuring instruments under their name or trademark.

The obligations of manufacturers in relation to regulated measuring instruments include:

1) Before placing a regulated measuring instrument on the GB market or putting into use, the manufacturer must ensure that it has been designed and manufactured in accordance with the essential requirements. The 2016 Regulations set these out in Schedule 1. They must have carried out the appropriate conformity assessment procedures referred to in Schedule 1B and have drawn up technical documentation.

2) Once this has been completed and before placing on the market, the manufacturer must draw up a declaration of conformity. The format of these is contained in Schedule 1K.

3) The manufacturer must ensure the declaration accompanies the regulated measuring instrument and affix the relevant conformity assessment marking (see section 8 (or section 9 for Qualifying NI Goods)) and the M marking visibly, legibly and indelibly to the measuring instrument or its data plate. Where it is not possible or warranted, on account of the nature of the instrument, to affix the conformity assessment and M markings to the instrument, they must be affixed to the packaging and the accompanying documents.

4) The manufacturer must keep the declaration of conformity up to date and keep it and the technical documentation for 10 years beginning with the day after the day on which the measuring instrument has been placed on the GB market.

5) The manufacturer must ensure that procedures are in place for series production to remain in conformity with the essential requirements and the regulated measuring instruments are labelled with the type, serial or batch identification (where that is not possible, the information may be marked on the packaging and the accompanying documents).

6) The manufacturer shall indicate their name, registered trade name or registered trademark and postal address (also indicating a single point at which the manufacturer can be contacted) on every regulated measuring instrument. Where this is not possible it may be provided on the packaging or accompanying documentation. ^{[footnote 2]}

7) The manufacturer must ensure regulated measuring instruments they place on the market are accompanied by a copy of the EU declaration of conformity relating to the instrument and by (unless the instrument’s simplicity makes it unnecessary) instructions and information on their operation which is easily understood by end-users and is in clear, legible and easily understandable English (see regulation 12).

8) The manufacturer, when appropriate with regard to the performance of a regulated measuring instrument, carry out sample testing of instruments and investigate any complaints about regulated instruments manufactured by them made available on the GB market and keep records of these complaints, any non-conforming instruments and measuring instrument recalls, and keep distributors informed of any such monitoring.

9) The manufacturer must take action where they have reason to believe that the regulated measuring instruments they have placed on the GB market is not in conformity with the legal requirements of the 2016 Regulations by bringing the instruments into conformity, withdrawing the instruments or recalling the instruments. Where the instrument presents a risk, the manufacturer must immediately inform the market surveillance authority (MSA), giving details of how the instrument is not in conformity and any corrective measures taken. Read more information on how to notify the MSA.

10) Manufacturers must also cooperate with and provide information to competent authorities following any reasoned requests. Where the regulated measuring instrument presents a risk, the manufacturer must immediately inform the competent national authorities of in NI or in EEA 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.

In addition, an importer (see below) or distributor who: (a) places a regulated measuring instrument on the relevant 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 the 2016 Regulations may be affected; will be treated as the manufacturer and accordingly subject to the manufacturer’s obligations.

Manufacturers wishing to place goods on the NI market should follow the Regulation as it applies to NI. Qualifying NI goods can be placed on the GB market without any additional approvals, although additional information as to the UK based importer may be required, if the goods have an importer based in the EU/EEA. See further detail in Section 9 on Qualifying NI Goods.

5. Obligations of authorised representatives

Manufacturers are able to appoint authorised representatives to perform certain tasks on their behalf under a written mandate.

Mandated authorised representatives for the GB market can be based in GB or NI, but cannot be based outside the UK. A manufacturer can only mandate an authorised representative established in the UK, under the Regulations as they apply in GB.

No GB-based authorised representatives are recognised under EU law. This means GB-based authorised representatives cannot carry out tasks on the manufacturer’s behalf for products being placed on the NI or EEA markets. Therefore, a GB manufacturer selling products to the EEA or into NI, who wishes to appoint an authorised representative to carry out tasks for them in respect of those products, must appoint an authorised representative based in NI or the EEA.

An authorised representative must comply with all the duties, imposed on the manufacturer under the Regulations, that they are appointed for and mandated by the manufacturer to perform. The manufacturer remains responsible for the proper performance of any obligations the authorised representative performs on their behalf.

The mandate shall at least allow the authorised representative to perform the following tasks:

1) keeping the declaration of conformity and the technical documentation at the disposal of the MSAs for 10 years beginning with the day after the day the regulated measuring instrument was placed on the GB market

2) further to a reasoned request from a competent authority, providing that authority with all the information and documentation necessary to demonstrate the conformity of the regulated measuring instrument

3) cooperating with the competent authorities, at their request, on any action taken to eliminate the risks posed by the regulated measuring instrument covered by the mandate

6. Obligations of importers

An importer is a person or business based in the UK who places measuring instruments on the GB market from a country outside the UK. This means that a UK business which acted as a ‘distributor’ before 1 January 2021 legally become an ‘importer’ if they place products from an EEA country or Switzerland on the GB market and therefore must comply with the importer duties under GB legislation.

This includes measuring instruments that are supplied to NI businesses from the EEA and then placed on the GB market. In this instance the NI business will take on importer obligations for EEA-supplied goods that are placed on the GB market (see also Section 9 on Qualifying NI Goods).

Importers have additional legal obligations that go beyond those of distributors, such as checking that manufacturers have carried out the required conformity assessment procedures, and including their (the importer’s) name, registered trade name or mark and a postal address on the regulated measuring instrument or, where this is not possible due to the size or sensitivity of the measuring instrument, on its packaging and in an accompanying document.

To assist with the transition, the UK is applying a transitional period ending on 31 December 2027 ^{[footnote 3]} to allow GB distributors of goods from the EEA or Switzerland (who from 1 January 2021 are importers into the GB market) to provide their details on the accompanying documentation as an alternative to placing them on the product itself. This applies to goods that are not qualifying NI goods. For further detail on qualifying NI goods, please see Section 9 on Qualifying NI Goods.

Can you be contacted easily if there is a problem?

A key principle underpinning legal metrology, for the benefit of consumers and regulators, is traceability of an instrument product back to its source.

In recognition that under the new regulatory regime you may have the new status of an importer when placing regulated measuring instruments from an EEA state or Switzerland on the GB market, you are temporarily permitted when placing such instruments on the market (until 31 December 2027) to indicate your name, registered trade name or trademark and a postal address in a document accompanying the instrument, instead of on the instrument itself. As set out above, this is usually only permitted where it is not possible to provide the specified information on the instrument itself due to its size or sensitivity. This additional temporary easement is permitted until 31 December 2027.

We understand that it may be difficult to provide your details on documentation accompanying each and every individual product.

You may therefore use an alternative method where, for example, your contact information is on a document accompanying a batch of products. This document would then follow each batch of products through the distribution chain. Your contact details must follow each product through the distribution chain, but not necessarily by one document per product. Ultimately, the end user, each distributor (and a regulator) must be able to access the information.

Methods which enable traceability of the product after the initial batch has been broken up could include:

• The importer address is present in shipping documents.
• The importer address is present on the invoice to the GB customer.
• The importer address is present on the label that is on the outer packaging (“shipper”) in which a number of finished goods is packed (normally customers will receive shippers unless the order is very small so that the shipper has to be opened and split).
• The importer address is included on the EU Declaration of Conformity and/or UK Declaration of Conformity (whichever is relevant for the product in question).

You should work with your distributors to ensure physical documentation does accompany batches of product as far as possible, and in all cases that there are measures in place to ensure end users are able to identify the UK importer.

Alongside that, but not as an alternative, you can use your company website to provide more information, access to product details and contact points for retailers, consumers and enforcement bodies.

These options are for a time limited period only and may not be used after 31 December 2027. You are encouraged to put in place measures to ensure that individual items do carry the importer’s address where required ahead of this date.

The EU does not have any such transitional provision. In the absence of this, measuring instruments being sold from GB to NI or the EU must be labelled with the NI or EU-based importer’s address.

Read guidance on the regulations in NI.

The obligations of importers in relation to regulated measuring instruments include:

1) Before placing a regulated measuring instrument on the GB market or putting into use, the importer must ensure that the required conformity assessment procedures referred to in Schedule 1B have been carried out by the manufacturer. This means that the instrument must comply with the essential requirements applicable to that class of instrument set out in Schedule 1.

2) The importer must ensure that the manufacturer has drawn up the technical documentation and the instrument is accompanied by a copy of the declaration of conformity and the other documents referred to in regulation 12 and has complied with the obligations to mark the manufacturer’s contact details and serial numbers etc.

3) The importer must ensure that the instrument bears the relevant conformity assessment marking (see section 8 (or section 9 for Qualifying Northern Ilreand goods)) and the M marking and is accompanied by the declaration of conformity and where relevant the required documents and information on its operation in clear, legible and easily understandable English.

4) When deemed appropriate with regard to the performance of a regulated measuring instrument, the importer must carry out sample testing of instruments made available on the GB market by the importer, keep a register of complaints, non-conforming regulated measuring instruments and recalls of regulated measuring instruments, and keep distributors informed of any such monitoring.

5) The importer must indicate their name, registered trade name or trademark and a postal address on the instrument. Where this is not possible, due to the size or sensitivity of the instrument, it may be provided on any of the instrument’s packaging and in any accompanying documents, or where the importer has imported the instrument from an EEA state or Switzerland and places it on the GB market before 31 December 2027, on an accompanying document. This must be in clear, legible and easily understandable English.

6) The importer must keep a copy of the declaration of conformity for a period of 10 years beginning with the day after the day on which regulated measuring instrument has been placed on the GB market or put into use and ensure that the technical documentation can be made available to MSAs on request.

7) The importer must ensure that regulated measuring instruments under their responsibility are safely stored and transported in such a way that does not jeopardise conformity with the essential requirements.

8) The importer must take action where they consider or have reason to believe that regulated measuring instruments they have placed on the GB market or put into use are not in conformity with the 2016 Regulations.

9) Where the 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. The importer should also inform the manufacturer and MSA (if the latter is different to the competent authority). Read more information on how to notify the MSA.

10) The importer must cooperate with and provide information to a competent authority following any reasoned requests.

7. Obligations of distributors

UK businesses that were distributors of goods within the EEA should now consider whether they are importers from the EEA and therefore what additional responsibilities they may have – see section 6 above. The same applies to distributors of goods from the EEA and Switzerland.

A distributor is any person, other than the manufacturer or importer, who makes a regulated weighing instrument available on the GB market.

The obligations of distributors include:

1) Before making a regulated measuring instrument available on the GB market or putting into use, the distributor must take due care to ensure that it is in conformity with the 2016 Regulations.

2) Before making a regulated measuring instrument available on the GB market or putting into use, the distributor must ensure that:

a) the instrument it bears the relevant conformity assessment marking (see section 8 (or section 9 for Qualifying NI goods)) and the M marking

b) where relevant, the instrument is accompanied by a copy of the declaration of conformity and instructions and information on the operation of the instrument in a manner easily understood by end users (unless the simplicity of the instrument makes the supply of that information unnecessary)

c) the manufacturer and importer have complied with the marking requirements to allow for identification of themselves and the instrument

3) The distributor must ensure that the regulated measuring instruments under their responsibility are safely stored and transported in such a way that does not jeopardise their conformity with the essential requirements.

4) Where the distributor considers or has reason to believe that a regulated measuring instrument is not in conformity with the essential requirements it must not make that instrument available on the market or put it into use until it has been brought into conformity. The distributor should also immediately inform the manufacturer and importer (where the distributor is not also the manufacturer and/or importer) that the instrument presents a risk, giving details, in particular, of the non-compliance of the instrument and of any corrective measures taken by the distributor.

5) The distributor must take action where they have reason to believe that regulated measuring instruments they have placed on the GB market or put into use are not in conformity with the 2016 Regulations.

6) Where the 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. The distributor should also immediately inform the importer and manufacturer (to the extent the distributor is not also performing those roles) of the same. The instrument must not be made available on the market or put into use until it has been brought into conformity. Read more information on how to notify the MSA.

7) The distributor must cooperate with and provide information to a competent authority following any reasoned requests.

8. Conformity assessment and marking before placing measuring instruments on the GB market

As set out in section 5 above, before placing an instrument on the GB market or using it for their own purposes, the manufacturer must:

a) design and manufacture the instrument in accordance with the essential safety requirements

b) determine the conformity procedure that applies, carry out the relevant conformity assessment procedure, (or have it carried out by an independent third party, depending on the category the product falls into), and draw up the relevant technical documentation

The product should then be marked with the applicable conformity assessment marking, provided it meets the essential requirements, and the relevant conformity assessment procedure has been carried out and/or a certificate has been issued by the relevant body.

What conformity assessment marking should the product have and when?

In line with the Government’s announcements on 1 August 2023 and 24 January 2024 about extended recognition of CE marking for products intended for the GB market, the Product Safety and Metrology etc. (Amendment) Regulations 2024 were made on 23 May 2024, and came into force on 1 October 2024.

These regulations extend recognition of CE marking indefinitely in GB. This allows businesses to use either CE or UKCA markings when placing goods on the GB market beyond 31 December 2024.

However, if GB based businesses wish to place products on the EEA market, they will continue to require a CE marking before the product is placed on the EEA market, including NI.

Self-declaration

Manufacturers placing equipment and protective systems on the GB market on the basis of self-declaration of conformity (where the Regulations permit) can affix either the UKCA marking or the CE marking before placing equipment on the GB market.

It is possible to affix both the UKCA marking and the CE marking to the same equipment, where conformity procedures are based on self-declaration, as long as the EU and GB requirements remain the same. When selling to the EU or supplying to NI, the CE marking remains mandatory.

Where independent third-party conformity assessment is required

Placing on the market in GB	Conditions to be met	Timeframe
Can be CE marked	If the product was conformity assessed by an EU Notified Body (but not a UK Approved Body), and meets all the essential safety requirements	Since 31/12/20
Must be UKCA marked	If the product has been conformity assessed by a UK Approved Body, and meets all the essential safety requirements	Since 31/12/20
Can be UKCA marked, but not CE marked	If the product is intended for placing on the GB market after 1 October 2024, and conformity assessment steps have been begun by an EU Notified Body and completed by a UK Approved Body, and has met all the essential safety requirements	New, since 1 October 2024

Placing on the market in NI	Conditions to be met	Timeframe
Must be CE marked	If the product was conformity assessed by an EU Notified Body and meets all the essential safety requirements	Since 31/12/20
Must be CE + UKNI marked	If the product has been conformity assessed by a UK Approved Body, and meets all the essential safety requirements	Since 31/12/20

Placing on the market in EEA	Conditions to be met	Timeframe
Must be CE marked	If the product was conformity assessed by an EU Notified Body (but not a UK Approved Body), and meets all the essential safety requirements	Since 31/12/20

Can a product be dual marked CE and UKCA?

Yes, but only, and before placing on market:

a) where an EU Notified Body has completed conformity assessment procedures for CE marking, and

b) where a UK Approved Body has completed conformity assessment procedures for UKCA marking, and it meets all the essential safety requirements

OR from 1 October 2024:

c) where an EU Notified Body has completed conformity assessment procedures for CE marking and it meets all the essential safety requirements, the product can also be UKCA marked, or

d) where an EU Notified Body has begun conformity assessment procedures for CE marking, and these have then been completed by a UK Approved Body for UKCA marking and it meets all the essential safety requirements, the product can be UKCA marked

Can a CE marked product already on the market, subsequently be UKCA marked?

A product already on the market, marked with a CE marking, cannot subsequently be UKCA marked, unless it has undergone full conformity assessment by a UK Approved Body and meets all the essential requirements.

The M Marking is still required when either the UKCA marking or the CE marking is used.

Any queries about CE marking or UKCA marking policy should be directed to Goods.Regulation@businessandtrade.gov.uk.

Where do I affix the conformity assessment marking?

The conformity assessment marking should be affixed visibly, legibly and indelibly to the instrument. Where it is not possible or not warranted on account of the nature of the instrument to affix the conformity assessment marking directly on the instrument (or its data plate), then it can be affixed to the packaging and accompanying documents.

Until 31 December 2027, the UKCA marking may be affixed to a label affixed to the instrument or a document accompanying the instrument, rather than being affixed to the instrument itself (even where it is otherwise possible to affix it to the instrument itself). ^{[footnote 4]}

Placing on the market

A fully manufactured good is ‘placed on the market’ when there is a written or verbal agreement (or offer of an agreement) to transfer ownership or possession or other rights in the product. This does not require physical transfer of the good.

You can usually provide proof of placing on the market on the basis of any relevant document ordinarily used in business transactions, including:

• contracts of sale concerning goods which have already been manufactured and meet the legal requirements
• invoices
• documents concerning the shipping of goods for distribution

Products imported for further manufacture and components

When products are imported into GB for further manufacture or processing, they are not considered placed on the market. Only fully manufactured products can be considered placed on the market. Under these circumstances, the GB manufacturer of the finished product has the sole and ultimate responsibility for ensuring it iscompliant before they place it on the GB market.

A finished product must be compliant with all applicable legislation when placed on the GB market. Components may be placed on the market separately and can constitute a fully manufactured product in its own right. This may include a requirement for the components of the product to be individually conformity assessed and marked. However, for many products, a single marking covering the overall product is sufficient.

Spares

Products which are repaired, refurbished or exchanged without changing their original performance, purpose, or type, are not considered ‘new’ and therefore do not need to be recertified and remarked.

This includes if the product is temporarily exported for repair (as the product is not being placed on the GB market for the first time when re-imported).

Repair, replacement and maintenance operations are often carried out using other products which are spare parts. Spare parts are considered to have been placed on the market at the time at which the original product or system they are ultimately intended to repair, replace or maintain was placed on the market.

This means that spare parts can comply with the same conformity assessment requirements that were in place at the time the original product or system they are ultimately intended to repair, replace or maintain was placed on the market.

The definition of a spare part will vary depending on the commercial context, but it is broadly determined by a product’s ultimate intended usage. Whether a product is ultimately intended to be used as a spare part should be evidenced by any document demonstrating this intended use, which should be produced when requested by MSAs.

If the product has been subject to important changes, substantially changing its original performance, purpose, or type, it will be considered as a ‘new’ product. Therefore, the modified product must comply with the relevant legislative requirements at the time the product is first placed on the market or put into service.

9. Qualifying Northern Ireland Goods

The Government committed to providing unfettered access for qualifying NI goods to the rest of the UK market after 1 January 2021. Products that can be placed on the market in NI in accordance with the legislation, as it applies to NI, can be sold in the rest of the UK without any additional approvals.

This means that products that are qualifying NI goods can be sold in the rest of the UK if any of the following apply:

• the CE marking is lawfully applied to the good on the basis of self-declaration
• any mandatory third-party conformity assessment was carried out by an EU-recognised notified body (including a body in a country with which the EU has a relevant mutual recognition agreement) and a CE marking is affixed
• the certificate of conformity previously held by a UK approved body has been transferred to an EU-recognised notified body and a CE marking has been affixed, or
• any mandatory third-party conformity assessment was carried out by a UK-based body, and the good is therefore marked with the CE marking and with the new UKNI marking

This will be the case even if there are changes between the EU rules that apply in NI under the terms of the Windsor Framework and the GB rules.

Read guidance on UKNI marking.

NI businesses that are importing products from the EEA and placing them on the GB market must ensure that the relevant conformity assessment procedure has been carried out, that the technical documentation has been drawn up and that the equipment bears the CE marking. They will also have to comply with the importer labelling duties (see Section 6 on obligations of importers).

Read guidance on qualifying NI goods.

10. Approved Bodies

The UK established a new framework for UK based bodies to assess products against GB rules. Existing UK notified bodies were granted new UK ‘approved body’ status and are listed on a new UK database.

Approved bodies are conformity assessment bodies which have been approved by the Secretary of State to carry out the procedures for conformity assessment and certification as set out in the 2016 Regulations.

These approved bodies retain their 4-digit identification number. New approved bodies will be assigned a number by the Office for Product Safety and Standards (OPSS) on behalf of the Secretary of State.

UK approved bodies can assess products for the GB market against UK essential requirements (which are, as yet, substantially the same as EU essential requirements).

Approved bodies must be established in the UK and be independent of the manufacturer. Approved bodies must examine the technical documentation and supporting evidence in respect of a regulated non-automatic weighing instrument to assess the adequacy of the technical design.

Where an approved body finds that essential requirements have not been met by a manufacturer, they must not issue a certificate of conformity and they must require the manufacturer to take corrective measures.

Access the list of UK Approved Bodies.

The register also contains details of bodies in other countries such as Australia, New Zealand, Canada, Japan, and the United States of America, which the UK is designating as Approved Bodies through Mutual Recognition Agreements.

11. Market surveillance and enforcement

The GB MSA for regulated measuring instruments is the Secretary of State with enforcement action carried out by OPSS.

RAMS (Regulation (EC 765/2008, as amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, sets out requirements for market surveillance of products) in relation to regulated measuring instruments.

The 2016 Regulations give powers to the MSA to take action against economic operators for products that present a risk or are not in conformity with the Regulations. There are requirements on economic operators to co-operate with the MSA as appropriate on request (see sections 4,6,7).

The 2016 Regulations also gives powers to the UK MSA to enforce the Regulations. OPSS will take all appropriate measures to withdraw from the GB market or to prohibit and restrict the supply of regulated measuring instruments which present a metrological risk on grounds of public interest, protection of the environment, protection of consumers, the levying of taxes and duties or fair trading.

In GB:

• OPSS on behalf of the Secretary of State is responsible for enforcing the 2016 Regulations.
• The Secretary of State for Transport is responsible for enforcing the 2016 Regulations in relation to taximeters and exhaust gas analysers.
• Local trading standards authorities have a duty to enforce the 2016 Regulations except in relation to gas meters, active electrical energy meters, taximeters and exhaust gas analysers.

Regulators’ Code

The MSA must continue to have regard to the Regulators’ Code when developing the policies and operational procedures that guide its regulatory activities in this area. It should carry out its activities in a way that supports those it regulates to comply and grow, including choosing proportionate approaches that reflect risk.

In responding to non-compliance that it identifies, the regulator should clearly explain what the non-compliant item or activity is, the advice being given, actions required, or decisions taken, and the reasons for these. Unless immediate action is needed to prevent a serious breach, the regulator should provide an opportunity for dialogue in relation to the advice, requirements or decisions, with a view to ensuring that they are acting in a way that is proportionate and consistent. OPSS takes account of the provisions of both the Regulators’ Code and the Growth Duty in exercising the Secretary of State’s regulatory functions.

Read the Regulators’ Code.

Criminal penalties

An economic operator or person committing an offence under the 2016 Regulations is liable to a fine on summary conviction. OPSS is able to impose a monetary penalty of up to £50,000 in respect of a failure to comply with an obligation under regulation 33; with a requirement imposed by or under regulation 60(6); or with a direction given under regulation 63 or 65.

12. Glossary

• Approved Body – A conformity assessment body which has been approved by the Secretary of State.
• Authorised Representative – A person appointed in writing by a manufacturer to perform specific tasks for the manufacturer. Authorised representatives for the GB market must be based in the UK. Manufacturers remain ultimately responsible for ensuring these tasks are carried out properly.
• CE marking – the conformity assessment marking used by the European Union. Certain goods (including simple pressure vessels) can be placed on the GB market bearing the CE marking. Where third party conformity assessment is required before the CE marking can be affixed, the assessment must be carried out by a Notified Body, not a UK Approved Body.
• Competent Authority – In GB, for regulated measuring instruments other than gas meters; active electrical energy meters; taximeters; and exhaust gas analysers, this is local trading standards authorities. OPSS, on behalf of the Secretary of State for Business and Trade, is responsible for enforcing the 2016 Regulations in relation to gas meters and active electrical energy meters. The Secretary of State for Transport is responsible for enforcing the 2016 Regulations in relation to taximeters; and exhaust gas analysers.

• Declaration of conformity – A document prepared by the manufacturer which must detail the following:

  • the specific regulated measuring instrument to which the declaration is referring
  • the name and address of the manufacturer and, where applicable, their authorised representative

This must be kept by the manufacturer for a period of ten years from the date on which the regulated measuring instrument was placed on the GB market. This declaration must be made available to the competent authority upon request.

• Distributor – Any person in the GB supply chain, other than the manufacturer or the importer, who makes a regulated measuring instrument available on the GB market.
• Economic Operator - means a manufacturer, authorised representative, importer or distributor
• Importer – A person established in the UK who places a regulated measuring instrument from a country outside of the UK on the GB market. This includes a person based in NI who has been supplied with the product from an EEA country, who would, under NI law, be a distributor. A person who before 1 January 2021 (under EU Rules) distributed measuring instruments within the EU (including the UK, and including Switzerland) is now an importer if they are bringing regulated measuring instruments into GB from another country (including EEA states or Switzerland).
• Manufacturer – A person who manufactures a regulated measuring instrument or has a regulated measuring instrument designed or manufactured and markets that instrument under their name or trademark.
• UKCA Marking – The UK Conformity Assessed (UKCA) marking is the new UK conformity marking used for certain goods (including measuring instruments) being placed on the GB market.
• UKNI Marking (also known as the UK(NI) indication) – The UKNI marking is a new marking applied in addition to the CE marking, where a good requiring mandatory third-party conformity assessment has been tested against EU requirements by a UK body. The UKNI marking applies when placing such products on the NI market. Under the Government’s unfettered access commitments, products lawfully marked with the UKNI marking can also be placed on the GB market if they are also qualifying NI goods.

13. Footnotes

1. Please note that Part 3 of the MIR which says that a manufacturer wishing to place a non-prescribed MI on a state in the EEA market may demonstrate compliance with the essential requirements of that market by following the rules as they are for regulated MI, is disapplied for the GB market. ↩

2. WELMEC Guide 8.9 allows for glass, ceramic and plastic moulded capacity serving measures, due to the physical characteristics of such products, to provide this information in a document accompanying the batch or consignment and on the packaging. ↩

3. would be extended until 31 December 2025. On 14 November 2022 the Government announced it would be extending the provisions for importer labelling until 31 December 2027. The Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022 (SI 2022/1393) give effect to this. ↩

4. On 24 August 2021 the Government announced the transition periods for UKCA marking and UKCA labelling would each be extended until 31 December 2022 and 31 December 2023 respectively. The Product Safety and Metrology etc (Amendment) Regulations 2021 gave effect to this. On 20 June 2022, the Government announced the provisions for UKCA labelling would be extended until 31 December 2025. On 14 November 2022 the Government announced it would be extending the transition period for UKCA marking until 31 December 2024 and the provisions for UKCA labelling and importer labelling until 31 December 2027. The Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022 (SI 2022/1393) gave effect to this. ↩