1. Appoint a UK Responsible Person (UKRP)

The Medicines and Healthcare products Regulatory Agency (MHRA) requires non-UK manufacturers to appoint a UK Responsible Person (UKRP) to place a device on the market. The UKRP functions similarly to an authorized representative.

Adding the UKRP to the device labeling is only necessary if the device has UK Conformity Assessed (UKCA) marking. Until you obtain UKCA marking, you do not need to update your labeling to sell in the UK. Currently, the MHRA allows manufacturers to use their CE Marking.

There is no official UKRP symbol equivalent to the European EC-REP or Swiss CH-REP symbols at this time.

2. Register your devices with the MHRA

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

After the application is submitted, the MHRA reviews it and issues marketing authorization. Note that this registration is not a ‘certification’ or ‘approval,’ as clarified in the MHRA’s registration guidance. Instead, it is a way for the MHRA to better monitor and understand the products being placed on the market.

The MHRA had set ‘Brexit’ transition deadlines for these registrations, which have now passed. Therefore, registration is mandatory before placing products on the UK market.

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

3. Notify the MHRA of your UK Importer

Unlike the EU MDR/IVDR, UK medical device regulation does not specifically define the role of an importer. However, if a manufacturer has a UK importer, this importer must be registered with the MHRA. The UK Responsible Person (UKRP) will complete this registration. Importer information is not disclosed in the MHRA’s public access database; instead, it is listed in the UKRP’s private online account with the MHRA.

4. Obtain UK Conformity Assessed (UKCA) Marking

Overview of CE Marking Transition Period

The MHRA has introduced a new conformity assessment process for Great Britain known as UKCA marking. However, it is not mandatory at this stage.

There is currently a transition period that allows companies to market devices based on their CE marking until:

• MDD/AIMDD CE marked legacy devices: until 30 June 2028 or until the device no longer qualifies as a legacy device under MDR Article 120.
• IVDD CE marked legacy devices: until 30 June 2030 or until the device no longer qualifies as a legacy device under IVDR Article 110.
• MDR/IVDR CE marked devices: until 30 June 2030 or until the CE certificate expires.

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

This means that, while companies may choose to obtain UKCA marking early, they can also continue to market their devices based on CE marking during the transition period. After the transition dates, UKCA marking will become mandatory for continued marketing in Great Britain.

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