Statutory guidance

Pressure Equipment (Safety) Regulations 2016: Northern Ireland

Updated 4 December 2024

Guidance on the regulations as they apply to equipment being supplied in or into Northern Ireland.

December 2024

1. Introduction

This Guide is for businesses placing pressure equipment on the market in Northern Ireland.

Under the terms of the Windsor Framework, ^{[footnote 1]} Northern Ireland (NI) aligns with relevant EU rules (in Annex 2) relating to the placing on the market of manufactured goods. Pressure equipment placed on the NI market must follow UK law as it applies to NI. The relevant law is the Pressure Equipment (Safety) Regulations 2016, which apply across the UK, but some of the provisions apply differently in NI so that they continue to implement in NI the Directive 2014/68/EU on Pressure Equipment.

This Guide is designed to help you comply with the Pressure Equipment (Safety) Regulations 2016, as they apply in NI. References to “the 2016 Regulations” in this document are references to the Pressure Equipment (Safety) Regulations 2016, as they apply in NI.

The 2016 Regulations set out the requirements that must be met before pressure equipment or assemblies can be placed on the NI market. The purpose of the legislation is to protect consumers and other end users from unsafe products by requiring manufacturers to show how their equipment or assemblies meet the ‘essential safety requirements’.

Since 16 July 2021, the EU Regulation on Market Surveillance 2019/1020 (referred to as “MSC” in this document) has replaced the market surveillance provisions in the Regulation on Accreditation and Market Surveillance 765/2008. Under the terms of the Windsor Framework, EU rules on goods apply in NI, including MSC, which will be directly applicable in NI and applies in addition to the 2016 Regulations. MSC does not apply in Great Britain (GB).

Article 4 of MSC requires that an economic operator responsible for compliance must be based in the EU (or NI) in order to lawfully place certain products on the market, including pressure equipment. This responsible economic operator must fulfil certain compliance tasks. This Guide summarises key requirements of Article 4, but detailed guidance is available here.

Read guidance on placing certain products on the NI market.

Pressure equipment placed on the GB (“GB”) market (GB comprises England, Scotland and Wales) must follow the separate rules for the GB market. If you are placing pressure equipment on the market in GB, you should read the relevant separate guidance.

Read guidance on the regulations in GB.

The government is committed to providing unfettered access for qualifying NI goods to the rest of the UK market. Pressure equipment that can be placed on the market in NI in accordance with the 2016 Regulations, as they apply to NI, can be sold in the rest of the UK without any additional approvals. The arrangements here are explained in detail in the separate guidance for placing pressure equipment on the market in GB.

2. Legislative Background

Directive 2014/68/EU on pressure equipment and assemblies was implemented into UK law by the Pressure Equipment (Safety) Regulations 2016 (SI 2016 No.1105).

The Directive continues to be implemented in respect of NI, under the terms of the Windsor Framework. However, the 2016 Regulations (as they apply in NI) also implement parts of the Windsor Framework which have particular provisions in them, recognising that the UK has left the EU.

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

The 2016 Regulations were amended by Product Safety and Metrology etc. (Amendment etc.) (UK(NI) indication) (EU Exit) Regulations 2020, the Pressure Vessels (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 and the Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 to give effect to the Windsor Framework as it relates to the placing on the NI market of pressure equipment. ^{[footnote 2]}

3. Scope

The 2016 Regulations apply to pressure equipment and assemblies with a maximum allowable pressure PS greater than 0.5 bar, although there are a number of exclusions, which are set out in regulation 4 and Schedule 1 to the 2016 Regulations. “Pressure equipment” means vessels, piping, safety accessories and pressure accessories. “Assembly” means several pieces of pressure equipment assembled assembled to form an integrated and functional whole. For full details of ‘permanent joints’, ‘piping’, ‘pressure accessories’, ‘safety accessories’ and other definitions see Regulation 2.

These regulations do not apply to pressure equipment placed on the market before 8 December 2016.

For the avoidance of doubt, the manufacture of pressure equipment by private individuals for their own use is excluded from the scope of the 2016 Regulations.

4. Product classification

In order to know how the 2016 Regulations apply to specific items of pressure equipment, the manufacturer will need to know:

• the type of equipment concerned, i.e. vessel, steam generator or piping
• the state of the intended fluid contents – gas or liquid
• the fluid group of the intended contents – Group 1 or Group 2

Group 1 comprises those substances and mixtures, as defined in points (7) and (8) of Article 2 of Regulation (EC) No 1272/2008 of the European Parliament and the Council on classification, labelling and packaging of substances and mixtures (“the CLP Regulation”), that are classified in accordance with the following physical or health hazard classes laid down in Parts 2 and 3 of Annex I to that Regulation:

• unstable explosives or explosives of Divisions 1.1, 1.2, 1.3, 1.4 and 1.5
• flammable gases, category 1 and 2
• oxidising gases, category 1
• flammable liquids, category 1 and 2
• flammable liquids, category 3 where the maximum allowable temperature is above the flashpoint
• flammable solids, category 1 and 2
• self-reactive substances and mixtures, type A to F
• pyrophoric liquids, category 1
• pyrophoric solids, category 1
• substances and mixtures which in contact with water emit flammable gases, category 1, 2 and 3
• oxidising liquids, category 1, 2 and 3
• oxidising solids, category 1, 2 and 3
• organic peroxides types A to F
• acute oral toxicity, category 1 and 2
• acute dermal toxicity, category 1 and 2
• acute inhalation toxicity, category 1, 2 and 3
• specific target organ toxicity - single exposure, category 1

Assistance with identifying the hazard classes of substances can be found on the European Chemicals Agency (ECHA) website.

Group 1 also comprises substances and mixtures contained in pressure equipment with a maximum allowable temperature TS which exceeds the flashpoint of the fluid.

Group 2 comprises substances and mixtures not referred to under group 1, within the definition of a fluid, including steam.

With this information the manufacturer can identify the relevant chart in Annex II of the Directive and determine the correct classification of the equipment by plotting the maximum allowable pressure and, in the case of vessels, the volume in litres or, for piping, the nominal size (DN).

The obligations of economic operators with regard to pressure equipment and assemblies depend on their classification. Equipment and assemblies within scope which are below or equal to the limits set out in the 2016 Regulations (see regulation 6(a)-(c) and 7) must be designed and manufactured in accordance with the principals of sound engineering practice of NI or an European Economic Area (EEA) State in order to ensure safe use and must be accompanied by adequate instructions for use. Unless required by other applicable EU legislation, this second category of equipment and assembly must not bear the CE marking. This is set out in regulation 8 of the 2016 Regulations.

In the paragraphs below, unless indicated otherwise, the references to pressure equipment or assemblies does not include those under the limits referred to in regulation 8.

5. Responsible economic operator as defined by MSC

If pressure equipment or an assembly is offered for sale or supply to NI (or EU) consumers, it is considered to be placed on the EEA market. Article 4 requires that a responsible economic operator must be based in NI (or the EU) to carry out certain compliance tasks in respect of that equipment. This can be the manufacturer, an importer, a manufacturer’s authorised representative, or a fulfilment service. They must carry out the compliance tasks in Article 4 and their contact details must be indicated on the equipment or on its packaging, the parcel or an accompanying document.

Read guidance on placing certain products on the Northern Ireland market.

6. Obligations of manufacturers

The 2016 Regulations

A manufacturer is a person who manufactures pressure equipment and/or assemblies, or has pressure equipment and/or assemblies designed or manufactured, and either markets that pressure equipment under their name or trademark or uses it for their own purposes.

The obligations of manufacturers of pressure equipment include:

1) Before placing relevant pressure equipment on the NI market or using it for their own purposes, a manufacturer must ensure that it has been designed and manufactured in accordance with the essential safety requirements; or, in the case of equipment falling within regulation 8, that it meets the requirements of that regulation.

2) The manufacturer then must:

a) classify the equipment or assembly into the appropriate category

b) decide which conformity assessment marking (CE, or CE + UKNI) they intend the equipment to have when placed on the NI market

c) determine the conformity procedure that applies, draw up the relevant technical documentation

d) 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)

3) Once the relevant conformity assessment procedure has been done, but before placing the product on the market, a manufacturer must:

a) draw up an EU Declaration of Conformity, ensure that declaration accompanies the product

b) affix the CE marking visibly, legibly and indelibly to the equipment. ^{[footnote 3]} Where it is not possible or warranted, on account of the nature of the equipment, to affix the CE marking to the equipment, it must be affixed to the packaging and the accompanying documents.

4) Where applicable, they must also ensure that the identification number of the notified body is affixed to the equipment or assembly.

5) When conformity assessment has been carried out by a UK notified body, the UK marking (also known as the UK(NI) indication) must be affixed as well as the CE marking. A product with the both the CE and the UKNI markings cannot be placed on the EEA market. There is separate guidance on when and how to use the UKNI marking. Read guidance on UKNI marking.

6) Manufacturers must keep the EU Declaration of Conformity up to date and keep it and the relevant technical documentation for 10 years.

7) Manufacturers must label their products with their name, registered trade name or registered trademark and address; the type batch or serial number (or other identification) in a language that is easily understood by the end user. If the end user is in NI, the language must be English. This applies to all products (including those to which regulation 8 refers). Where it is not possible to put this information on the pressure equipment or assembly, the manufacturer must ensure it is given on its packaging or a document accompanying the equipment or assembly.

8) When placing pressure equipment or an assembly on the NI market, a manufacturer must ensure that it is accompanied by instructions and safety information in a language which can be easily understood by the end user. If the end user is in NI, the language must be English. This applies to all products (including those to which regulation 8 applies).

9) Manufacturers must ensure that procedures are in place for series production to remain in conformity with Part 2 of the 2016 Regulations. In doing so, they must take account of any changes in pressure equipment or assembly design or characteristics, and any change in a harmonised standard or in another technical specification by reference to which the EU Declaration of Conformity was drawn up.

10) When appropriate, with regard to the risks to the health and safety of consumers and other users, they must carry out sample testing and they must investigate any complaints that the pressure equipment or assemblies they have placed on the NI market are not in conformity with the 2016 Regulations, and keep records of these complaints, of products found not to be in conformity, and of product recalls.

11) Manufacturers must take action where they have reason to believe that any product is not in conformity with the 2016 Regulations. Where pressure equipment or an assembly presents a risk, the manufacturer must immediately inform the market surveillance authority (MSA) of the risk, and the competent authorities of any relevant state in which the manufacturer has made the equipment available on the market, of the risk, giving details of (a) the respect in which the pressure equipment or assembly is considered not to be in conformity with Part 2; and (b) any corrective measures taken. Read more information on how to notify the MSA.

MSC

If pressure equipment or an assembly is offered for sale or supply to NI (or EU) consumers, it is considered to be placed on the EEA market. Article 4 requires that a responsible economic operator must be based in NI (or the EU) to carry out certain compliance tasks in respect of that equipment. This can be the manufacturer, the importer, a manufacturer’s authorised representative, or a fulfilment service. The responsible economic operator must:

1. Keep documentation: Verify that the EU declaration of conformity or declaration of performance and technical documentation have been drawn up, keep the declaration of conformity or declaration of performance at the disposal of MSAs for 10 years and ensure that the technical documentation can be made available to those authorities upon request.
2. Provide documentation: If a reasoned request is made by an MSA, provide them with all information and documentation necessary to demonstrate the conformity of the product.
3. Notify risk: If there is reason to believe a product presents a risk, inform the MSA.
4. Cooperate: Cooperate with MSAs, including requests to take appropriate corrective action. If that is not possible, mitigate the risks presented by the product when they believe the product presents a risk or are requested to do so by the MSAs.

The contact details of the responsible economic operator must be indicated on the product or on its packaging, the parcel or an accompanying document.

7. Obligations of authorised representatives

A manufacturer can appoint an authorised representative to perform certain tasks on their behalf.

An authorised representative appointed by a manufacturer to represent them in either the NI or EEA markets cannot be based in GB. This means that GB based authorised representatives cannot carry out tasks on the manufacturer’s behalf for products being placed on the NI or EEA markets.

An authorised representative based in NI can, under the 2016 Regulations as they apply in NI, carry out tasks on the manufacturer’s behalf for products placed on the NI or EEA markets.

An authorised representative must comply with all the duties imposed on the manufacturer under the 2016 Regulations that they are appointed in writing by the manufacturer to perform. There are some duties that a manufacturer cannot mandate an authorised representative to perform (e.g. conformity assessment) and some that must form part of the authorised representatives mandate (e.g. retention of technical documentation).

A manufacturer remains responsible for the proper performance of any obligations the authorised representative performs on their behalf.

Any references in the 2016 Regulations to the manufacturer are to be taken to include a reference to the authorised representative including in relation to penalties for failure to comply with those duties.

8. Obligations of importers

For the purposes of the 2016 Regulations as they apply in NI, an importer is a business or person who is established in NI and places a product 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. Therefore, a business or person based in NI who is supplied with a product from GB will be an importer under the 2016 Regulations as they apply in NI, if they then sell that product on the NI (or EEA) markets.

The obligations of importers include:

1) Before pressure equipment is placed on the NI market, an importer must ensure:

a) the relevant conformity assessment has been carried out by the manufacturer

b) the equipment is in conformity with Part 2 of the 2016 Regulations

c) the manufacturer has drawn up technical documentation

d) the pressure equipment or assembly has the CE or CE + UKNI conformity assessment marking when relevant, and is accompanied by the required documents

e) the manufacturer has complied with the labelling requirements with regard to contact details and conformity assessment body number

2) When conformity assessment has been carried out by a UK notified body, the UK marking (also known as the UK(NI) indication) must be affixed as well as the CE marking. A product with both the CE and the UKNI markings cannot be placed on the EEA market. There is separate guidance on when and how to use the UKNI marking. Read guidance on UKNI marking.

3) The importer must keep a copy of the EU Declaration of Conformity and technical documentation for a period of 10 years after the pressure equipment or assembly has been placed on the NI market and must co-operate with and provide information to the enforcing authorities when requested.

4) When an importer has reason to believe that pressure equipment or an assembly is not in conformity with the essential safety requirements, the importer must not place the pressure equipment or assembly on the NI market.

5) The importer must provide their name trade, registered trade name and a postal address at which they can be contacted on the pressure equipment or assembly, where it is not possible to put this information on the equipment or assembly itself, it must be on its packaging or in a document accompanying the equipment or assembly.

6) The importer must ensure that when placing pressure equipment or assembly on the market, they must ensure that it is accompanied by instructions which can be easily understood by the end user where it is to be made available. If that is NI, the language is English.

7) The importer when appropriate, having regard to the risks to the health and safety of consumers and other users, must carry out sample testing of the pressure equipment or assembly and must investigate complaints about pressure equipment or assemblies that are not in conformity with the 2016 Regulations and keep a register of those complaints.

8) The importer must take action where they have reason to believe that any product they have placed on the NI market is not in conformity with the 2016 Regulations. Where pressure equipment or an assembly presents a risk, the importer must immediately inform the MSA of the risk, and the competent authorities of any relevant state in which the importer has made the equipment available on the market, of the risk, giving details of (a) the respect in which the pressure equipment or assembly is considered not to be in conformity with Part 2; and (b) any corrective measures taken. Read more information on how to notify the MSA.

9) The importer must ensure that pressure equipment or assembly under their responsibility must be transported and stored in conditions that do not affect their conformity with the essential safety requirements.

9. Obligations of distributors

A distributor is any person, other than the manufacturer or importer, who makes equipment or an assembly available on the NI market.

NI businesses which were distributors of pressure equipment supplied to them from GB should now consider whether they are classified as importers under the 2016 Regulations and therefore what additional requirements they need to comply with – see section 7 above. Under the 2016 Regulations an NI business placing a product from GB on the NI market does so as an importer, not as a distributor.

The obligations of distributors include:

1) Before making pressure equipment or an assembly available on the NI market a distributor must ensure that it is in conformity with Part 2 of the 2016 Regulations, meaning that it conforms with the essential safety requirements and that each economic operator has complied or is complying with the obligations imposed on them under Part 2.

2) Before making pressure equipment or an assembly available on the NI market, a distributor must verify that:

a) the pressure equipment or assembly bears the CE marking (for pressure equipment under regulations 6 or 7)

b) the pressure equipment or assembly is accompanied by the required documents, the instructions and safety information

c) the manufacturer and importer have complied with their labelling and identification requirements

3) When conformity assessment has been carried out by a UK notified body, the UK marking (also known as the UK(NI) indication) must be affixed as well as the CE marking. A product with both the CE and the UKNI markings cannot be placed on the EU market. There is separate guidance on when and how to use the UKNI marking. Read guidance on UKNI marking.

4) They must ensure that pressure equipment or assemblies under their responsibility must be transported and stored in conditions that do not affect their conformity with the essential safety requirements.

5) Where the distributor has reason to believe that the pressure equipment or assembly which the distributor has made available on the NI market is not in conformity with Part 2, they must not make it available on the NI market until it is brought into conformity.

6) The distributor must take action where they have reason to believe that any product they have placed on the NI market is not in conformity with the 2016 Regulations. Where pressure equipment or an assembly presents a risk, the distributor must immediately inform the MSA of the risk, and the competent authorities of any relevant state in which the distributor has made the equipment available on the market, of the risk, giving details of (a) the respect in which the pressure equipment or assembly is considered not to be in conformity with Part 2; and (b) any corrective measures taken. Read more information on how to notify the MSA.

7) The distributor must also cooperate with and provide information to enforcing authorities when requested.

10. Placing products 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

The relevant economic operator (whether manufacturer, importer or distributor) bears the burden of proof for demonstrating when the good was placed on the market.

11. Conformity Marking

Where pressure equipment is being placed on the NI market, and the manufacturer chooses to have it conformity assessed by a EU recognised body, the marking for the NI and EEA markets continues to be the CE marking.

The CE marking can continue to be used for the GB market ^{[footnote 4]} as long as all the other rules have been complied with.

Where the manufacturer chooses to have the equipment conformity assessed by a UK Notified Body, the CE marking must be accompanied by the UKNI marking (also known as the UK(NI) indication). Products with the UKNI marking cannot be placed on the EEA market.

There is separate guidance on when and how to use the UKNI marking.

Read guidance on UKNI marking.

12. Notified Bodies

Notified Bodies are independent organisations notified to the European Commission to carry out the procedures for conformity assessment and certification set out in the 2016 Regulations.

All UK Notified Bodies have remained Notified Bodies for the purpose of CE marked products for the NI market. This includes recognised third-party organisations (RTPO) and user inspectorates (UI). When these UK bodies are used for mandatory conformity assessment activity, then the manufacturer will need to affix both the CE and the UKNI markings. A product with both the CE and the UKNI markings cannot then be placed on the EEA market. There is separate guidance on when and how to use the UKNI marking.

Read guidance on UKNI marking.

A list of EU Notified Bodies can be found on the NANDO website. Economic operators requiring conformity assessment and CE marking are free to select any suitable Notified Body from any Member State. If a manufacturer uses a Notified Body from this list, then they apply only the CE marking to their product (not the CE UKNI marking).

Access the list of UK Notified Bodies.

13. Qualifying Northern Ireland Goods

The Government is committed to providing unfettered access for qualifying NI goods to the rest of the UK market. Pressure equipment that can be placed on the NI market in accordance with the 2016 Regulations can be sold in the rest of the UK without any additional approvals. The guide to placing pressure equipment on the GB market has further details on these arrangements.

Read guidance on qualifying NI goods.

14. Enforcement

For products intended for workplace use, the Health and Safety Executive for Northern Ireland (HSENI) has a duty to enforce the Regulations and MSC in NI.

In NI district councils have a duty to enforce the 2016 Regulations in relation to private use or consumption.

The 2016 Regulations provides powers to MSAs to take action against economic operators for products that present a risk and/or are not in conformity with the 2016 Regulations as set out in regulations 71 and 73. Economic operators are also required to co-operate with the enforcement authority and on request, must provide information and take action as appropriate.

Safeguard procedure

Enforcement authorities are required under the 2016 Regulations to take all appropriate measures to withdraw from the NI market, or to prohibit or restrict the supply of products bearing CE Marking which may endanger the health and safety of persons, property or the environment if the relevant economic operator does not do so. Under the safeguard procedure, the UK must inform the European Commission and EU Member States immediately of any enforcement action taken indicating the reasons justifying the action. This will enable Member States to take action against similar products placed on the market on their territories. Similarly, if an EU Member State initiates the procedure with respect to action taken on their territories, certain actions are required of UK MSAs and the Secretary of State. The European Commission will determine whether the action taken is justified; if so UK enforcement authorities must take necessary measures to ensure the equipment is withdrawn from the market.

Regulators’ Code

MSAs must have regard to the Regulators’ Code when developing the policies and operational procedures that guide their regulatory activities in this area. They should carry out their activities in a way that supports those they regulate to comply and grow, including choosing proportionate approaches that reflect risk.

In responding to non-compliance that they identify, regulators 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 risk regulators 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. The Secretary of State takes account of the provisions of both the Regulators’ Code and the Growth Duty in exercising his regulatory functions.

Read the Regulators’ Code.

Penalties

Penalties can include:

• a fine or prison sentence of up to three months or to both on summary conviction, or
• a fine or prison sentence of up to two years or both on conviction on indictment

While it is matter for the enforcement authority to decide whether prosecution is appropriate in each case, should a prosecution take place, and the economic operator is found to be in breach, it is at discretion of the court to decide the penalties imposed on the offender.

15. European Commission Guidance

Access guidance from the European Commission.

The Commission has produced guidance called the Blue Guide intended to contribute to a better understanding of EU product safety rules and to their more uniform and coherent application across different sectors and throughout the single market.

Access the Blue Guide from the European Commission.

16. Glossary

• Approved Body – A conformity assessment body which has been approved by the Secretary of State or was a UK ‘Notified Body’ prior to 1 January 2021 able to carry out conformity assessment of products with a view to UKCA marking. They are not recognised by the EU (unless they have a presence in the EU) and cannot approve CE marking.
• Authorised Representative – A person appointed in writing by a manufacturer to perform specific tasks for the manufacturer. An authorised representative can be based anywhere in the EEA or NI, but cannot be based in GB, in respect of products being supplied on the NI market. Manufacturers remain ultimately responsible for ensuring these tasks are carried out properly.
• CE marking – the CE marking must be placed on products which are intended for the EU or NI markets and have either been conformity assessed by an EU Notified Body or, where the Regulations permit, have been demonstrated and declared by the manufacturer as meeting the essential safety requirements.
• Distributor – Any person in the EEA or NI supply chains, other than the manufacturer or the importer, who makes a product available in the EEA or NI markets.
• Enforcing Authority – In NI, for products in the use in the workplace, the enforcing authority is the Health and Safety Executive for Northern Ireland (HSENI). For products for private use it is district councils.

• EU Declaration of conformity – A document prepared by the manufacturer which must detail, amongst other things, the following:

  • the specific product 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 product was placed on the NI market. This declaration must be made available to the enforcing authority upon request.

• Fulfilment service – A natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved. This does not include postal, parcel or freight services. ^{[footnote 5]}
• Importer – A person who is established in NI and places a product 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. A person based in NI who before 1 January 2021 distributed a product from GB on the NI (or EEA) market, is now an importer if they are bringing products into NI from GB.
• Manufacturer – A person who manufactures pressure equipment or assemblies or has them designed or manufactured and markets that product under their name or trademark.
• Notified Body – A conformity assessment body based in the EEA which has been approved and notified by an EEA Member State to carry out conformity assessment for placing products on the EU and NI markets; or a conformity assessment body that is based in the UK and have been approved and notified by the Secretary of State, including bodies which were notified bodies whilst the UK followed EU rules. If these UK based Notified Bodies are used, the CE marking must be accompanied by the UKNI marking and cannot be placed on the EEA market (just the NI market, or, where it is also a qualifying NI good, the GB market)
• UKCA marking – The UK Conformity Assessed (UKCA) marking is the UK conformity marking which can be used for certain goods being placed on the GB market, in place of the CE marking, which is the conformity marking used in the European Union. Products being placed on the NI market cannot be UKCA marked and must continue to be CE marked. There are special arrangements in place to ensure NI’s unfettered access to the rest of the UK.
• UKNI marking (also known as the UK(NI) indication) – The UKNI marking must be used along with the CE marking if manufacturers wish to use a UK Notified Body for conformity assessment. The UKNI marking allows the product to be placed on the NI market (and, under the Government’s unfettered access commitments, where the product is also a qualifying NI good, on the GB market), but not the EEA market.

17. Footnotes

1. The “Windsor Framework” has the same meaning as set out in Joint Declaration No 01/2023 by the United Kingdom of Great Britain and Northern Ireland and the European Union in the Withdrawal Agreement Joint Committee on the Windsor Framework on 24 March 2023. ↩

2. In 2019, the Pressure Equipment (Safety) Regulations 2016 were amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 to fix any deficiencies that arose from the UK leaving the EU (such as references to EU institutions) and make specific provision for the UK market. The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 were then 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 Windsor Framework. ↩

3. There are exceptions to conformity marking the equipment or assembly. Regulation 11(2) excludes conformity marking under modules A2, C2 F or G, and where conformity assessment is carried out by a user inspectorate. ↩

4. 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. ↩

5. Fulfilment service is defined in Article 3 of MSC and for the purposes of MSC only is considered an economic operator. There are no specific obligations on fulfilment services under the 2016 Regulations, but they may have additional obligations where they are the responsible economic operator in respect of a product under Article 4 MSC. ↩