Statutory guidance

Regulation EU 2016/425 and the Personal Protective Equipment (Enforcement) Regulations 2018: Northern Ireland

Updated 4 December 2024

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This publication is available at https://www.gov.uk/government/publications/personal-protective-equipment-enforcement-regulations-2018/regulation-eu-2016425-and-the-personal-protective-equipment-enforcement-regulations-2018-northern-ireland

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

December 2024

1. Introduction

This Guide is for businesses placing personal protective equipment (PPE) 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. PPE placed on the NI market must therefore follow UK law as it applies to NI. The relevant law is the Regulation EU 2016/425 (“the 2016 Regulation”) and the Personal Protective Equipment (Enforcement) Regulations 2018 (“the 2018 Regulations”), as they apply to NI.

The 2016 Regulation sets out the essential requirements which must be met before PPE products can be placed on the NI market. The purpose of the legislation is to ensure safe products are placed on the NI market by requiring manufacturers to show how their products meet the ‘essential requirements’. The 2018 Regulations establishes a system to enforce the 2016 Regulation.

This guidance is designed to help you comply with the 2016 Regulation and the 2018 Regulations (referred to in this document collectively as “the PPE Regulations”), as they apply in NI.

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 Regulation. 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 PPE. 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.

PPE placed on the GB market (GB comprises England, Scotland and Wales [footnote 2] must follow the separate rules for the GB market. If you are placing PPE 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. PPE that can be placed on the market in NI in accordance with the PPE Regulations, as they apply to NI, can be sold in the rest of the UK without any additional approvals. The arrangements for this are explained in detail in the separate guidance for placing PPE on the market in GB.

2. Legislative background

The 2016 Regulation applies to all PPE first placed on the market since 21 April 2018 and continues to have direct effect in NI under the terms of the Windsor Framework. The 2018 Regulations implement an enforcement and sanctions system in UK law.

The 2018 Regulations are amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, the Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 and the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 to accommodate the UK exit from the EU and give effect to the Windsor Framework as it relates to the placing on the NI market of PPE. [footnote 3]

There is therefore one set of 2018 Regulations, but some of the provisions apply differently in NI and GB. References to the 2018 Regulations in this guidance are references to those Regulations as they apply in NI.

3. Scope

The PPE Regulations apply to PPE which is:

a) equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety

b) interchangeable components for equipment referred to in point (a) which are essential for its protective function

c) connexion systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use

The PPE Regulations do not apply to PPE:

a) specifically designed for use by the armed forces or in the maintenance of law and order

b) designed to be used for self-defence, except for PPE intended for sporting activities

c) designed for private use to protect against:

  • atmospheric conditions that are not of an extreme nature
  • damp and water during dishwashing

d) for exclusive use on seagoing vessels or aircraft that are subject to the relevant international treaties applicable to the UK

e) for head, face or eye protection of users, that is covered by Regulation No 22 of the United Nations Economic Commission for Europe on uniform provisions concerning the approval of protective helmets and their visors for drivers and passengers of motorcycles and mopeds

Some types of products that appear to be similar to PPE may actually be regulated as medical equipment if their main purpose is to protect others from the user (like a surgical face mask). A medical gown, for example, is a medical device if it is to protect the patient from the healthcare worker. If it is to protect the healthcare worker from the patient, it is PPE. A product that serves both purposes is regulated both as a medical device and as PPE, and must meet the requirements for both.

Read further information about the regulation and safety of medical devices.

4. Requirements

The 2016 Regulation

The essential health and safety requirements (listed in Annex II of the 2016 Regulation) apply to all PPE within the scope of that Regulation.

Under article 19, all PPE within scope must undergo a conformity assessment procedure in accordance with its risk categorisation (specified in Annex I) to demonstrate compliance with the essential requirements.

MSC: Responsible economic operator

If PPE 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 PPE. 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 PPE or on its packaging, the parcel or an accompanying document.

Read guidance on placing certain products on the NI market.

5. Obligations of manufacturers

The 2016 Regulation

A manufacturer is a person who manufactures PPE, or has PPE designed or manufactured, and markets that PPE under their name or trademark.

The obligations of manufacturers of PPE include:

  1. Before placing PPE on the NI market, a manufacturer must ensure that it has been designed and manufactured in accordance with the applicable essential health and safety requirements. These are set out in Annex II to the 2016 Regulation.
  2. A manufacturer must have had a relevant conformity assessment procedure carried out and technical documentation drawn up.
  3. Once this has been done a manufacturer must draw up an EU Declaration of Conformity, ensure that the declaration accompanies the product, and affix the CE marking visibly, legibly and indelibly to the PPE. Where it is not possible or warranted, on account of the nature of the PPE, to affix the CE marking to the PPE, it must be affixed to the packaging and the accompanying documents.
  4. When conformity assessment has been carried out by a UK approved body, the UKNI marking (also known as the UK(NI) indication) must be affixed as well as the CE marking. PPE with the CE and UKNI markings cannot be placed on the EEA market. There is separate guidance on when and how to use the UKNI marking online. Read guidance on UKNI marking
  5. Manufacturers must keep the EU Declaration of Conformity [footnote 4] and the technical documentation for 10 years after the PPE has been placed on the NI market.
  6. Manufacturers must ensure that procedures are in place for series production to remain in conformity. Changes in the design or characteristics of the PPE and changes in the harmonised standards or in other technical specifications by reference to which the conformity of the PPE is declared shall be adequately taken into account.
  7. When deemed appropriate with regard to the risks presented by PPE, manufacturers shall, to protect the health and safety of consumers and other end-users, carry out sample testing of PPE made available on the NI market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring.
  8. The manufacturer must ensure that all PPE placed on the NI market bears a type and serial or batch number, or other element allowing its identification. The manufacturer should also include its name, registered trade name or registered trademark and postal address. Where the size or nature of the PPE does not allow this then it may be provided on the packaging or in an accompanying document.
  9. The manufacturer must ensure that PPE is accompanied by instructions and safety information as set out in point 1.4 of Annex II to the 2016 Regulation, which is in clear, legible and in easily understandable English.
  10. Manufacturers who consider or have reason to believe that PPE which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that PPE into conformity, to withdraw it or to recall it from the NI market, as appropriate. Furthermore, where the PPE presents a risk, manufacturers shall immediately inform the enforcement authority to that effect, and the competent authorities of any relevant state in which the manufacturer has made the PPE available on the market, of the risk, giving details, in particular, of the non-conformity and of any corrective measures taken. Read more information on how to notify the MSA.

MSC

If PPE 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 PPE. 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 market surveillance authorities (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.

6. 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 him 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 PPE Regulations as they apply in NI, carry out tasks on the manufacturer’s behalf for products placed on the NI or EEA markets.

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

  • Keeping the EU Declaration of Conformity and the technical documentation at the disposal of the MSA in the UK for 10 years after the PPE has been placed on the EEA market.
  • Further to a reasoned request from the enforcement authority in the UK, providing that authority with all the information and documentation necessary to demonstrate the conformity of the PPE.
  • Cooperating with the enforcement authority in the UK, at its request, on any action taken to eliminate the risks posed by PPE covered by the authorised representative’s mandate.

An authorised representative must comply with all the duties imposed on the manufacturer under the PPE Regulations that they are appointed 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 PPE 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.

7. Obligations of importers

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

The obligations of importers include the following:

  1. Before placing PPE on the NI market, an importer must ensure that the appropriate conformity assessment procedures referred to in article 19 have been carried out by the manufacturer. They must ensure that the manufacturer has drawn up technical documentation; the PPE bears the CE marking; [footnote 5] and is accompanied by the declaration of conformity and required documents and identification marks.
  2. When conformity assessment has been carried out by a UK notified body, the UKNI marking (also known as the UK(NI) indication) must be affixed as well as the CE marking. PPE 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.
  3. When deemed appropriate, regarding risk presented by an item of PPE, the importer must carry out sample testing of PPE they have placed on the NI market, investigate and, if necessary, keep a register of complaints, of non-conforming PPE and recalls of such PPE, and keep distributors informed of any such monitoring.
  4. Importers must indicate on the PPE their name, registered trade name or registered trademark and postal address. This obligation does not apply where the importer has set out such information on the packaging of the PPE.
  5. The importer must ensure that PPE is accompanied by instructions and safety information as set out in point 1.4 of Annex II to the 2016 Regulation ensure that they are clear, legible and in easily understandable English.
  6. The importer must keep a copy of the declaration of conformity [footnote 4] for a period of 10 years after the PPE has been placed on the NI or EEA market at the disposal of the MSA and ensure that the technical documentation can be made available to that authority, upon request.
  7. The importer must ensure that PPE under their responsibility are safely stored and transported in such a way that does not jeopardise conformity with the essential health and safety requirements.
  8. Importers who consider or have reason to believe that PPE which they have placed on the NI market is not in conformity with the 2016 Regulation must immediately take the corrective measures necessary to bring the PPE into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, importers shall immediately inform the enforcement authority in NI to that effect, and the competent authorities of any relevant state in which the importer has made the PPE available on the market, of the risk, giving details, in particular, of the non-conformity and of any corrective measures taken. Read more information on how to notify the MSA.
  9. Importers must, further to a reasoned request from the enforcement authority in NI, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of PPE in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have placed on the NI market.

8. Obligations of distributors

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

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

The obligations of distributors include the following:

  1. Before making PPE available on the NI market, a distributor must act with due care to ensure that it is in conformity with the 2016 Regulation, which means the PPE must be in conformity with the essential health and safety requirements.
  2. Before making PPE available on the NI market, a distributor must ensure that it bears the CE marking; [footnote 6] is accompanied by instructions and information as set out in point 1.4 of Annex II to the 2016 Regulation and ensure and that they are clear, legible and in easily understandable English; and that the manufacturer and importer have complied with the marking requirements as to required labelling.
  3. The distributor must ensure that PPE under their responsibility is safely stored and transported in such a way that does not jeopardise its conformity with the essential health and safety requirements.
  4. Distributors who consider or have reason to believe that PPE which they have placed on the NI market is not in conformity with the 2016 Regulation must immediately take the corrective measures necessary to bring the PPE into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, importers shall immediately inform the enforcement authority in the UK to that effect, and the competent authorities of any relevant state in which the distributor has made the PPE available on the market, of the risk, giving details, in particular, of the non-conformity and of any corrective measures taken. Read more information on how to notify the MSA.
  5. Distributors must, further to a reasoned request from the enforcement authority in the UK, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of PPE in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have placed on the market.

9. 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.

10. Conformity Marking

Where PPE is being placed on the NI market, and the manufacturer chooses to have it conformity assessed by an 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 7] as long as all the other rules have been.

Where the manufacturer chooses to have the PPE 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.

11. Qualifying Northern Ireland Goods

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

Read guidance on qualifying NI goods.

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 PPE Regulations.

Access the list of NI Notified Bodies.

All active UK Notified Bodies remain Notified Bodies for the purpose of CE marking products for the NI market. When these UK bodies are used for mandatory conformity assessment activity, then the manufacturer will ned to affix both the CE and the UKNI markings. A product with both the CE and the UKNI marking 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. If a manufacturer uses a Notified Body from this list, then they apply only the CE marking to their product (not the both the CE and the UKNI markings).

Access the list of UK Notified Bodies.

13. Enforcement

As set out in the 2018 Regulations, for PPE intended for workplace use, or for use otherwise than at work in non-domestic premises made available to persons at a place where they may use the PPE provided for their own use there, the Health and Safety Executive for Northern Ireland (HSENI) acts as the MSA and has a duty to enforce the PPE Regulations in NI.

In NI district councils have a duty to enforce the PPE Regulations in relation to PPE retained for private use or consumption (other than in circumstances subject to the remit of HSE/HSENI).

Where PPE is intended to be used exclusively or primarily on relevant nuclear sites as defined in regulation 3(4) of the 2018 Regulations, the Office for Nuclear Regulation is responsible for enforcing the PPE Regulations.

The 2018 Regulations give powers to enforcement authorities to take action against economic operators for PPE that presents a risk or is not in conformity with the 2016 Regulation. There are requirements on manufacturers, distributors and importers to co-operate with the enforcement authority as appropriate on request.

The 2018 Regulations also give the Secretary of State powers to enforce the 2016 Regulation and RAMS (Regulation (EC) 765/2008), in so far as they set out requirements for market surveillance of products.

UK MSAs will take all appropriate measures to withdraw from the market or to prohibit and restrict the supply of products which may endanger the health and safety of persons, property or the environment.

Safeguard procedure

Enforcement authorities are required under the 2016 Regulation 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 act 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 NI MSAs and the Secretary of State. The European Commission will determine whether the action taken is justified; if so, enforcement authorities must take necessary measures to ensure the PPE is withdrawn from the market.

Regulators’ Code

MSAs (HSE, HSENI, ONR and Local Authority Trading Standards) must continue to 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 breach, 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

A person committing an offence under the 2018 Regulations may be liable to a penalty. Penalties can include a fine or a prison sentence of up to three months for the most serious offences, or both. It is matter for the enforcement authority to decide whether prosecution is appropriate in each case taking into account the circumstances of the case and the enforcement authority’s own policies, operational procedures and practices in line with the Regulators’ Code. Should a prosecution take place, and the economic operator is found to be in breach, it is at the discretion of the court to decide the penalties imposed on the offender.

14. Where to find EU guidance about the EU Regulation on Personal Protective Equipment 2016/425

EU Regulation 2016/425 (“the 2016 Regulation”) is directly applicable in NI.

Access guidance from the European Commission.

The European Commission’s ‘Blue Guide’ aims to give a better understanding of EU product safety rules and to their application across different sectors and throughout the EU single market.

Access the Blue Guide from the European Commission.

15. 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 can 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 (Category 1), have been demonstrated and declared 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 this 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 8]
  • 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 the GB.
  • Manufacturer – A person who manufactures PPE or has it 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 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 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. 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.

16. 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. GB does not include the Isle of Man, or the Channel Islands. ↩

  3. In 2019, the PPE Regulations 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. ↩

  4. Manufacturers of PPE necessary for protection in the context of the COVID-19 outbreak, manufactured for healthcare workers and being purchased by the Government/ NHS will not have a Declaration of Conformity if the PPE has not been subject to conformity assessment procedures. ↩ ↩2

  5. When conformity assessment has been carried out by a UK approved body, the UK(NI) indication must also be affixed. ↩

  6. When conformity assessment has been carried out by a UK notified body, the UK(NI) indication must also be affixed. ↩

  7. 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. ↩

  8. 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 Regulation. ↩

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