Placing CE, or CE and UKNI marked products on the market in Northern Ireland

How to comply with regulations for manufactured products placed on the Northern Ireland market

Applies to Northern Ireland

This guide provides an overview of the steps businesses need to take when placing a product on the market in Northern Ireland under the Conformité Européenne (CE) regime. This process may differ for specific products as signposted throughout this guide. Product regulations should therefore also be consulted.

Under the Windsor Framework agreement relevant EU rules relating to manufactured products apply in Northern Ireland. The UK government has provided Northern Ireland-specific sector guidance on this page. However, the EU has also published a blue guide which provides guidance on CE marking.

CE markings demonstrate that the manufacturer believes that their product meets the relevant product requirements. The CE regime covers a range of product legislation under the EU new legislative framework known as 'new approach goods'. These product types are listed in the product marking table for Great Britain and Northern Ireland.

There is a range of sectors with UK-specific rules for products placed on the Northern Ireland market. You can access product safety sector guidance from the Office for Product Safety and Standards (OPSS) in the product safety for businesses: A to Z of industry guidance.

Solicitors, trade associations, local authority trading standards, and responsible departments can provide additional advice on which regulations apply to different products.

1. Identify the correct market

This guide also applies to products being placed on the Great Britain market originating from Northern Ireland. For qualifying products, the UK government will guarantee unfettered access, without the need for additional approvals.

Qualifying Northern Ireland products can be placed on the market in Great Britain based on the CE, or UK Northern Ireland Conformity Assessed (UKNI) and CE conformity markings used in Northern Ireland.

Find out more about:

• which products qualify for unfettered access
• the UK government's approach to unfettered access

Crown dependencies and British Overseas Territories

The UKCA marking does not apply in the Crown dependencies (Guernsey, Jersey and the Isle of Man).

Find product and consumer safety information for:

• Guernsey
• Jersey
• Isle of Man

The UKCA marking does not apply in the British Overseas Territories.

2. Understand roles and responsibilities

There are different roles known as 'economic operators' in the supply chain. Responsibilities for different economic operators vary.

Most of the responsibilities for placing a product on the market lie with the product's manufacturer. However, other economic operators within the supply chain have duties to fulfil.

Product regulations by sector should be consulted for specific economic operator requirements for a given product.

Manufacturer

A manufacturer is an individual or business who manufactures a product, or who has a product designed or manufactured and markets that product on the Northern Ireland market under their own name or trademark.

Their responsibilities include:

• designing and manufacturing the product in accordance with relevant requirements
• indicating identification details (name, trade name or trademark, and postal address) and applying the correct marking on the product
• drawing together and retaining product documentation (including a declaration of conformity)
• monitoring compliance and acting upon any concerns
• co-operating with market surveillance authorities

Authorised representative (of the manufacturer)

An authorised representative is an individual or company who is established in Northern Ireland and appointed by a manufacturer to carry out agreed tasks on their behalf.

There are constraints to what an authorised representative can be asked to do. For instance, they cannot usually be held responsible for ensuring that a product is designed and manufactured in accordance with essential requirements. Manufacturers ultimately remain responsible for any task they decide to delegate to an authorised representative.

The manufacturer may decide to appoint the company importing or distributing their product to carry out the delegated responsibilities of an authorised representative, in which case that company would adopt all relevant economic operator responsibilities.

An authorised representative may be essential or voluntary, depending on the regulation applicable to the product.

Their responsibilities include:

• fulfilling responsibilities as explicitly requested by the manufacturer in writing, such as:
  • affixing the conformity marking
  • drawing up and signing a declaration of conformity
  • keeping the necessary technical documentation
  • co-operating with market surveillance authorities
• monitoring compliance and acting upon any concerns

Importer

An importer is any individual or business established in the UK who supplies a product from a country outside of the UK for distribution, consumption or use in the course of a commercial activity.

Their responsibilities include:

• indicating identification details on the product (name, trade name or trademark, and postal address)
• ensuring that manufacturers have carried out the correct conformity processes, drawn up the relevant technical documentation, affixed the correct marking, and fulfilled their identification obligations
• retaining the product's documentation
• ensuring that storage or transport conditions do not jeopardise the product's compliance
• monitoring compliance and acting upon any concerns
• cooperating with market surveillance authorities
• maintaining a line of contact with the product's manufacturer

If an importer places products on the market under their own name or trademark, or modifies the product in a way that affects compliance or conformity, they assume the responsibilities of the manufacturer. This means they must hold sufficient information about the product's design and production, as they take on the legal obligations associated with affixing the CE, or CE and UKNI marking

Distributor

A distributor is a person in the supply chain, other than the manufacturer or importer, who makes products within the UK available on the Northern Ireland market.

Their responsibilities include:

• ensuring that importers and manufacturers have fulfilled their identification obligations
• ensuring that manufacturers have placed the correct marking on the product
• ensuring that storage or transport conditions do not jeopardise the product's compliance
• monitoring compliance and acting upon any concerns
• cooperating with market surveillance authorities

If a distributor places products on the market under their own name or trademark, or modifies the product in a way that affects compliance or conformity, they assume the responsibilities of the manufacturer. This means they must hold sufficient information about the product's design and production, as they take on the legal obligations associated with affixing the CE, or CE and UKNI marking.

End user

An end user is a person who uses a product. End users are not usually subject to obligations within CE product regulations. However, some professional end users who 'put products into service' may be subject to additional obligations, such as under product legislation or health and safety at work legislation.

3. Check which product rules apply

Products must be designed and manufactured in line with the rules set out in product regulations. This may require a conformity marking, such as a CE marking or CE and UKNI marking for the product to be placed on the market in Northern Ireland.

A product is placed on the market when it is supplied in the course of a commercial activity (whether in return for payment or free of charge) for distribution, consumption, or use. Conformity marking is only necessary if required under sector-specific regulations. Not all products must bear a conformity marking.

You can read about sector-specific requirements for CE and UKNI marking in product regulations by sector and current approaches to product marking under the UKCA and CE regimes.

The Windsor Framework agreement was formally adopted by the UK on 24 March 2023. Under the Windsor Framework, relevant EU rules relating to manufactured products apply in Northern Ireland.

These rules include the EC new approach directives available on the European Commission website.

It is common for more than one regulation to apply to a product. To place a conformity marking on a product, it must comply with all relevant regulations.

Product regulations establish essential requirements that products must meet to safeguard public interests such as:

• health and safety
• product performance
• environmental protection

These regulations outline the objectives to be achieved or the risks to be addressed, without prescribing specific technical solutions. This approach allows manufacturers flexibility in how they demonstrate compliance with those requirements.

Harmonised standards

Harmonised standards are standards which have been developed to give a statutory presumption of conformity with product regulations. These technical specifications are developed by a recognised European Standards Organisation such as the European Committee for Standardisation (CEN).

They are designed:

• as a practical way for manufacturers to meet essential requirements in legislation
• for repeated application and to provide a common framework for ensuring product safety and performance

However, their use in most cases is voluntary, and it should be noted that the presumption of conformity is rebuttable. Standards often include guidance on which requirements they aim to cover, but they may not address all the essential requirements in the relevant product regulations. Applying a standard does not replace legal obligations.

EU harmonised conformity standards are published in the Official Journal of the European Union. You can find details on whether designated standards are voluntary or mandatory in product regulations by sector and current approaches to product marking under the UKCA and CE regimes.

Where their use is voluntary, manufacturers can also choose not to rely on harmonised standards. However, they must be able to demonstrate how the product is compliant with the essential requirements in the regulations for their product.

Manufacturers remain fully responsible for assessing all risks associated with their products, identifying relevant requirements, and documenting how these are addressed.

4. Carry out a conformity assessment procedure

The available routes to demonstrate compliance with conformity requirements are set out in product regulations by sector and current approaches to product marking under the UKCA and CE regimes.

Under certain product regulations, the manufacturer can self-declare conformity for the product under the CE regime. However, other regulations specify circumstances where some or all types of products must be assessed by a Conformity Assessment Body (CAB).

Third-party conformity assessments undertake tests or review test reports to ensure that the product complies with the essential requirements of the product regulation.

In the EU, CABs are called notified bodies and are accredited under each country's accreditation body. They can be used to certify products for Northern Ireland with CE markings only. EU notified bodies can be found on the EU New Approach Notified and Designated Organisations (NANDO) database.

In the UK, CABs undertaking work for the Northern Ireland market are known as Northern Ireland notified bodies. If you are using a Northern Ireland Notified Body to carry out mandatory third-party conformity assessment for Northern Ireland, you need to also apply a UKNI, as well as a CE, marking.

The UK Market Conformity Assessment Bodies (UKMCAB) database lists UK-based Northern Ireland notified bodies which can provide conformity assessments for products being placed on the Northern Ireland market.

UK and EU CABs can be located either in their own market or in a third country under a mutual recognition agreement. You can read more about conformity assessment testing under mutual recognition or free trade agreements for the UK market.

5. Prepare documentation

Technical file

Under CE regulations, manufacturers must prepare a technical file. In most cases, this can be in digital format and should include:

• test reports
• design documents
• risk assessments
• any other information as set out in product regulations by sector

Declaration of conformity

Once the manufacturer is assured that the product is compliant, a declaration of conformity (DoC), which is a formal statement that the product complies with the applicable legislation must be created.

In some regulations, this is known as a Declaration of Performance (DoP). Other regulations also require declarations of incorporation (DoI), for partly completed equipment or machinery, which is a document stating that a product complies with relevant requirements but is not yet fully assembled or operational.

What the manufacturer needs to include in their DoC will vary, and manufacturers should check the relevant product regulations by sector for their product.

The DoC may include:

• the name and full business address of the manufacturer, or authorised representative (if applicable)
• the product's serial number, model, or type identification
• a statement, declaring the manufacturer takes full responsibility for the product's compliance
• the details of the approved body which carried out the conformity assessment procedure (if applicable)
• the relevant legislation with which the product complies
• references to the relevant harmonised (EU) standards, including the date of the standard or references to other technical specifications
• the name and signature of the person authorised to sign on behalf of the manufacturer or their authorised representative
• the date the declaration was issued
• supplementary information (if applicable)

6. Use the appropriate marking

It is the responsibility of the manufacturer (or authorised representative as agreed) to mark the product with the appropriate conformity marking.

Depending on the rules which apply to the product, the manufacturer may need to change the marking they use. The product regulations by sector will clearly set this out.

For products falling under the CE regime, in most cases, this will be the CE or CE with UKNI marking. However, there are some other markings for certain products. These include, but are not limited to, the following:

• the reversed epsilon "3" (for example, for aerosols)
• the Pi (π) marking (for example, some transportable pressure equipment)
• the Red Ensign or wheelmark (for example, marine equipment)

The UKNI marking is never used on its own. It always accompanies an EU conformity marking, for example, the CE marking, and is applied where the product has been third-party conformity assessed by a notified body, based in the UK. A product can have multiple different markings, as long as it complies with relevant requirements, and the markings can be clearly seen.

Manufacturers and importers must also indicate on the product:

• their name
• registered trade name or registered trademark
• postal address on the product

There may also be other product specific indications that manufacturers are required to include, such as the product:

• type identification
• batch number
• serial number
• model
• UK or EU Notified Body number

This information will be set out in product regulations by sector.

Where it is not possible to indicate this on the product (for example, because the product is too small), the legislation may allow the manufacturer to affix the information on the packaging or in a document accompanying the product.

Manufacturers must ensure that the product is accompanied by instructions. The precise content and nature of the instructions will be product specific, but they must be clear, legible, and for the Northern Ireland market be in easily understandable English.

When applying either CE only or UKNI and CE markings, the rules on marking must be met. Markings must be:

• in their standard, recognisable form
• scaled proportionately against the downloadable templates if their size is reduced or enlarged
• at least 5mm in height, unless a different minimum dimension is specified in the relevant legislation
• easily visible, legible, and indelible

The marking must be placed onto the product or to its data plate. If this is not possible or not necessary because of the nature of the product, it must be placed onto the packaging and accompanying documents.

Manufacturers can download a template CE marking and find further information on the European Commission website.

Manufacturers can download the UKNI marking to place on their product with a filled text option (ZIP, 35.3 KB), or with an outlined text option (ZIP, 2.03 MB).

7. Retain records and maintain compliance

Depending on the regulation, different economic operators must keep technical documentation to demonstrate a product is compliant with the applicable conformity requirements. In most cases, this is the manufacturer and importer. This information can be requested at any time, by market surveillance or enforcement authorities.

This documentation must be kept for the period specified in the legislation (typically 10 years) after each individual product has been placed on the Northern Ireland market (rather than the first product of a production run). However, you should refer to product regulations by sector to check for any differences to this period.

Economic operators must also be certain that procedures are in place to ensure that products comply with their relevant regulations when each individual product is placed on the Northern Ireland market. In doing so, changes in the product's design, characteristics, and designated standards or technical specifications to which the declaration of conformity was drawn up should be noted.

Economic operators have a duty to act where they have reason to believe that the product they have placed on the Northern Ireland market is not in conformity with the legal requirements of the relevant regulations. They must immediately take the corrective measures necessary to bring the product into conformity or withdraw or recall it.

There is further information available about:

• how to notify an enforcement authority
• how to report an unsafe product through the EU safety business gateway

If an enforcement body finds a product does not meet CE or CE with UKNI requirements, depending on the risk, they will often provide the relevant economic operator with an opportunity to work constructively to bring the product into conformity. If the economic operator fails to co-operate, they will be obliged to withdraw the product from the market or undertake a recall. The economic operator may also be liable for a fine and imprisonment.

Contact

Contact the goods regulation mailbox at goods.regulation@businessandtrade.gov.uk if you have any questions related to this guidance, or any suggestions for improvement.