UKCA Marking, Great Britain and UKNI & CE marking, Northern Irland

After the 1st of January 2021, the requirements associated with placing your products on the market in the UK change. 

 

The regulatory requirements are not changing significantly, and amendments are only being made to reflect the fact that the UK has left the EU and the transition period has ended, and to create a framework for a UK market that will replace the EU market. A new conformity marking, the UKCA marking, which can only be affixed if the products have been assessed by bodies approved by the UK authorities, applies after the transition period and certain economic operators (importers and authorized representatives) will have to be based in the UK at the end of this period. Products that meet EU requirements (including those that have been legally CE marked and/or tested by an EU-recognized conformity assessment body) may continue to be placed on the UK market between the 1st of January and 31st of December 2024. In addition, products tested by UK Notified Bodies before the 31 December 2020, but which have not yet been placed on the market, may also continue to be placed on the UK market until 31 December 2024. The changes take effect from January 1, 2021, but there are specific arrangements for "new" importers (who import products from EEA states or, in some cases, Switzerland) that allow relevant information (name and address, etc.) to be included on the documents accompanying the product, rather than on the product itself, until December 31, 2024.

 

Following the Trade and Cooperation Agreement signed on December 24, 2020 between the United Kingdom and the European Union (see the full agreement), new rules apply to place your products on the market in the United Kingdom (UK), distinguishing between Great Britain (England, Wales and Scotland) and Northern Ireland, with specificities according to the nature of your product (this is the case for medical devices) and according to the conformity demonstration procedure used.

 

 

For your electrical and electronic products excluding medical devices

UKCA marking to sell in Great Britain (England, Walles and Scotland)

The UKCA marking is applicable since January 1, 2021.
However, the CE marking can still be used during a transitional period until the 1st of January 2025 in most cases and no further action is required for your products placed on the market before the 1st of January 2021.
Be aware, however, CE marking is only valid in the UK where the UK and EU rules remain the same. If the EU changes its rules and you affix the CE marking on your product based on these new rules, you will not be able to use the CE marking to sell in Great Britain, even before December 31, 2024.

 

You should still take measures to ensure that you meet the new responsibilities of importers if you place a product from the EU market on the UK market.

 

The UKCA marking works on similar principles to the CE marking with, in particular, essential requirements to be met and standards equivalent to harmonized standards to verify that these requirements are met (UK equivalent for EMC, for Low Voltage and for Radio).

The circumstances in which you can do without a third party body to certify your conformity for the UKCA marking are the same as for the CE marking regarding the intervention of a Notified Body.
Conversely, third part bodies authorized to assess conformity for UKCA marking must be identified as Conformity Assessment Bodies by the UK authorities.

 

The UKCA marking becomes mandatory from January 1st 2025 but it can also be anticipated in case of marketing of your products in Great Britain, for products concerned by requirements covered by the UKCA marking as far as your conformity assessment uses an Assessment Body itself recognized by the British authorities. 

 

From January 1, 2025, the CE marking will no longer be recognized in the UK for areas covered by the UKCA marking. However, a CE marking product will still be valid for sale in the UK as long as it is also UKCA marking and complies with the relevant UK rules.

 

About your declarations of conformity and technical documentation for UKCA marking  

Requirements at this level are transposable to what is currently found in the framework of the CE marking: UKCA marking  rule with a mark to be permanently affixed as of January 1, 2025, technical documentation available for 10 years to verify the demonstration of compliance with the regulatory requirements..., declaration of conformity listing the legal requirements applicable to the product, name and address of the manufacturer (or your authorized representative) as well as information on the product and the conformity assessment body (if applicable).

The information required on the declaration of conformity are mostly the same as required on an EU declaration of conformity. It may vary depending on the implementing legislation, but generally must include

• Your name and full business address or the address of your representative
• Serial number, model or type identification of the product
• A declaration that you assume full responsibility for the compliance of the product
•  The name and address of the certified body that carried out the conformity assessment procedure (if applicable)
• The relevant legislation with which the product complies
• Your name and signature
• The date of emission of the declaration
• Additional information (if applicable)

You will need to list them:

• The relevant UK legislation (rather than EU legislation)
• Standards designated by the United Kingdom rather than standards quoted in the Official Journal of the European Union

 

In January 2022, the British standards are the same as the standards used in the EU and with the same reference.

 

The UKNI marking combined with the CE marking to sell your product in Northern Ireland

The regulations covering the placing of your products on the market in Northern Ireland are also applicable from 1st January 2021.

This regulation requires that the requirements of the CE marking apply.
If your conformity assessment is carried out by a third part, in theory a Notified Body, but you choose a body recognized by the British authorities, your CE marking will be accompanied by a UKNI marking.

As this organization is not recognized as a Notified Body under European regulations, a product with the double CE & UKNI marking cannot be placed on the market  in the European Union.

Furthermore the UKNI marking can not be used alone

 

For Northern Irish companies (and only Northern Irish companies), the UK government guarantees unfettered access to the entire UK market, without the need for additional approvals before placing products on the market in the rest of the UK. Thus, as the CE and CE & UKNI markings will be valid in Northern Ireland, products labelled with these markings can be placed on the market in Great Britain.
These companies will be able to continue to use the CE marking even if there are changes between the EU rules to which the Northern Ireland Protocol applies and the UK rules. This is part of the UK government's commitment to ensure that Northern Ireland businesses have unfettered access to the rest of the UK market. Note that in this context, Irish companies will be considered as importers for the English authorities.

 

About your declarations of conformity and technical documentation for UKNI marking

The requirements at this level are transposable to what is currently found in the framework of the CE / UKCA marking

 

 

 

Beware, Great Britain does not recognize EU-based representatives and persons responsible for placing on the market.
If you are required to (or choose to) use a representative or person responsible for placing the product on the market, they must be based in the UK for products placed on the UK market.

To summarize, and except for the transitional period during which, in most cases, the CE marking can still be used, here are the markings and associated regulations that will have to be respected as of January 1, 2025 for your placings on the market:

• In Great Britain (England, Walles and Scotland) - UKCAmarking *
• In Northern Ireland – CE marking or CE marking combined with UKNI marking
• In Northern Ireland and Great Britain: CE marking and UKCAmarking *
• In Europe and in Great Britain (including or not Northern Ireland : CE marking and UKCAmarking **

* Except for companies in Northern Ireland who will be able to use the CE (or CE & UKNI) marking
** Except for companies in Northern Ireland who will only need the CE mark (no equipment marked UKNI can be sold in Europe)

 

 

The special case of medical devices

As for other electrical and electronic equipment, the UKCA marking is applicable since January 1, 2021 for Great Britain and the UKNI for Northern Ireland.

The UK market is regulated by the MHRA (Medecines and Healthcare product Regulatory Agency).

After January 1, 2021, a transitional period will run until June 30, 2023 with the following details:

• Certificates issued by EU-recognized Notified Bodies will remain valid for the UK market until 30 June 2023.
• The EU no longer recognizes British notified bodies.
• UK Notified Bodies cannot issue CE certificates (except for the "CE UKNI" marking, which will be valid in Northern Ireland) - and have become UK Approved Bodies.
• A new channel for market access and product marking is available for manufacturers who wish to place a device on the UK market.
• As of January 1, 2021, all medical devices, including in vitro diagnostic (IVD) medical devices, placed on the UK market must be registered with the MHRA. There is a period of grace for registration:
  • Class III and Class IIb implants, as well as all active implantable medical devices and IVD List A products must be registered by May 1, 2021
  • Other Class IIb devices and all Class IIa devices as well as IVD List B products and self-test IVDs must be registered as of September 1, 2021
  • Class I devices, custom devices and general IVDs must be registered as of January 1, 2022
• Manufacturers of Class I devices, custom devices and general IVDs who, prior to January 1, 2021, were required to register their devices with the MHRA ( i.e., manufacturers based in the United Kingdom or third country manufacturers with representatives based in Northern Ireland) must continue to register their devices from January 1, 2021 on the same basis as now rather than in accordance with the dates above
• If you are a manufacturer based outside of the UK and you wish to place a device on the UK market, you must appoint a single person as the UK placing responsible person who will take responsibility for the product in the UK. More information on the UK responsible person is given below

 

The Active Implantable Medical Devices Directive 90/385/EEC, the Medical Devices Directive 93/42/EEC and the In Vitro Diagnostic Medical Devices Directive 98/79/EC have been transposed into UK legislation through the Medical Devices Regulations 2002 (SI 2002 No. 618, as amended) (UK MDR 2002).

This means that as of January 1, 2021, the United Kingdom's requirements for placing on the market and UKCA marking are still based on the requirements derived from the current European legislation.

CE marking will soon evolve for medical devices with the Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR) - EU Regulation 2017/745, whose entry into force dates are respectively May 26, 2021 and May 26, 2022, a date later than Brexit.
As these regulations will not enter into force until the transition period, they will not be automatically retained by the EU Withdrawal Agreement Act and will therefore not automatically apply in Great Britain. This means that the measures contained in the EU MDR and the EU IVDR will not be transposed into Great Britain legislation and will not be implemented in Great Britain.

 

Attention the radio requirements applicable to a medical device are regulated in the same way as for an electrical and electronic product (see first part of the document)

 

UKCA marking for placing on the market in Great Britain

Manufacturers can use the UKCA marking on a voluntary basis until June 30, 2023. From July 1, 2023, a UKCA marking will be required to place a device on the UK market. 
When a third party conformity assessment is required, a UK approved body is needed. However, manufacturers of Class I and general IVD devices are allowed to self-certify against the UKCA marking.
Le MHRA est The MHRA is responsible for designating UK approved bodies to carry out assessments against the relevant requirements for UKCA marking.

 

UKNI marking for placing on the market in Northern Ireland

The following requirements apply to manufacturers who wish to place medical devices on the market in Northern Ireland:

• The EU MDR and EU IVMDR will be applicable in Northern Ireland from 26 May 2021 and 26 May 2022 respectively 
• CE marking is mandatory. In addition, UKNI marking is required if a UK Notified Body undertakes a mandatory third party conformity assessment
• Certains dispositifs médicaux, y compris les dispositifs médicaux de diagnostic in vitro (DIV), mis sur le marché en Irlande du Nord doivent être enregistrés auprès de la MHRA. Class I devices and general IVDs placed on the market by Northern Ireland manufacturers and Northern Ireland-based authorized representatives must be registered as they were prior to January 1, 2021, as the registration deadlines will not apply to these devices. For other device classes, devices must be registered by the dates below:
  • Class III and Class IIb implantable devices, as well as all active implantable medical devices and IVD List A products must be registered by May 1, 2021
  • Other Class IIb devices and all Class IIa devices as well as IVD List B products and self-test IVDs must be registered as of September 1, 2021
• When placing devices on the market in Northern Ireland, UK-based manufacturers must appoint an authorized representative based in the EU or Northern Ireland
• Most manufacturers based outside of the UK must have a UK official in place to act as a regulatory point of contact in the UK and comply with registration requirements when they begin to apply.

 

For products related to UK actors that are placed on the market in Europe

CE marking continues to apply but British Notified Bodies are no longer recognized by Europe as of 31 December 2020.

Certificates issued by UK-based Notified Bodies thus no longer have validity in the EU.