How to sell your medical devices & IVDs in the UK

The United Kingdom (UK) withdrew from the European Union (EU) on 1 January 2020. Following this change, a transition period of nearly one year occurred to minimize the impact of the Brexit withdrawal.  

The transition period ended 31 December 2020, resulting in the following requirements for manufacturers placing devices onto the UK market.

1) Appoint a UK Responsible Person (UKRP)

The Medicines and Healthcare products Regulatory Agency’s (MHRA’s) requires that non-UK manufacturers appoint a UK Responsible Person, in order to place a device on the market. The UK representative is similar to an authorized representative.

The UKRP does not need to be added to the device labeling unless the device has UK Conformity Assessed (UKCA) marking. This means that until you obtain UKCA marking, you do not need to update your labeling in order to sell in the UK. The MHRA currently allows manufacturers to leverage their CE Marking.

At this time there is no official UKRP symbol, equivalent to the European EC-REP or Swiss CH-REP symbols. 

2) Register your devices with the MHRA

The UKRP must submit registrations on behalf of non-UK manufacturers. Both the manufacturer and the devices must be registered with the MHRA.

Once the application is submitted, the MHRA will review and issue marketing authorization. Note that the registration is not a ‘certification’ or ‘approval’, as noted in the MHRA’s registration guidance. Instead, it is a method for the MHRA to have better control and understanding of the products being placed onto the market.

The MHRA implemented ‘Brexit’ transition deadlines to complete the registrations, which have since passed. Therefore, registration is now mandatory before placing products on the UK market.

Once marketing authorization has been granted, the registration is published in the MHRA public access database.

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3) Notify the MHRA of your UK Importer 

The UK medical device regulation currently does not define the role of an importer, like the EU MDR/IVDR does. However, if a manufacturer does have a UK importer, that importer must be registered with the MHRA.

This registration will be completed by the UKRP. The importer information is currently not disclosed in the MHRA’s public access database. Instead, it is only listed in the UK representative’s private online account with the MHRA.

4) Obtain UK Conformity Assessed (UKCA) marking 

Overview of CE Marking Transition Period

The MHRA has developed a new conformity assessment process for Great Britain, called UKCA marking. However, it is not mandatory yet. 

There is currently a transition period in place. This allows companies to market devices based on their CE marking until:

The current UK medical device and IVD regulation is based on the old EU Directives. A new, more robust UK regulation is expected to go into effect in July 2025. 

This means that, while companies may voluntarily UKCA Mark their device early if they wish, they can also choose to market solely based on their CE Marking. After the above dates, then UKCA Marking becomes mandatory, and companies will need UKCA marking to continue marketing in Great Britain.

To learn more about the UKCA / CE Marking transition period, please read: New Dates for UK Regulation & CE Marking

What does this mean for me?

Between today and the transitional deadlines, companies can sell devices in the UK with only their European CE marking, as long as they meet the additional requirements outlined above. This means there is no major change for you, other than:

After the above transition period ends, you must obtain UKCA marking to keep selling in Great Britain.

What is UKCA marking?

It is similar to CE marking under the European Directives. In fact, current UKCA marking legislation is based on the Medical Devices Directive (MDD) / In Vitro Diagnostics Directive (IVDD). However, the MHRA has proposed major updates, many of which are comparable to the European Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).

The current UK Medical Device Regulation (UK MDR 2002) requires:

After the device has been UKCA marked, manufacturers must apply the UKCA Marking symbol to the device; add the UK Responsible Person to the labeling, if manufacturer is located outside of the UK; sign the UKCA Declaration of Conformity, asserting compliance with the UK regulation; and register the device with the MHRA. Even if the device was previously registered with the MHRA based on EU CE marking, it must be re-registered as a UKCA marked device.

Note About the UK Countries

The UK is made up of four countries and all four countries have left the European Union.

England, Scotland, and Wales = Great Britain. Great Britain requires appointment of a UKRP and registration of devices with the MHRA. Further, they will eventually require devices to be UKCA marked in order to be placed onto the Great Britain market. There is currently a transition period, to temporarily accept CE marked devices.

The fourth UK country is Northern Ireland. Northern Ireland requires, and will continue to require, CE marking to lawfully place devices onto its market. The MDR/IVDR registration requirements must be met for Northern Ireland. Where a manufacturer is not located in the EU/EEA, they are required to appoint an Authorised Representative prior to placing devices onto the Northern Ireland market.