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.
STEP 1: Appoint UK Responsible Person
All non-UK manufacturers must appoint a UK Responsible Person (UKRP), in order to place a device on the market. The UK representative is similar to a European authorized representative.
The UKRP must register your company and your devices with the Medicines and Healthcare products Regulatory Agency (MHRA). Non-UK companies cannot complete the registration without a UKRP.
STEP 2: Register with the MHRA
The UKRP must submit registrations on behalf of non-UK manufacturers. UK companies can complete this step on their own.
Both the manufacturer and the devices must be registered with the MHRA. There is no upfront registration fee; instead, the MHRA charges an annual fee of £300 per GMDN Level 2 category (this is the broad device type classification assigned to your product).
Once the application is submitted, the MHRA will review it within five business days. Note that the registration is not a ‘certification’ or formal ‘approval’ from the MHRA. Instead, it is a method for them to have better control and understanding of the products being placed onto the market.
Once the registration has been granted, it is published in the MHRA’s public access database.
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STEP 3: Notify 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.
Note About the UK Countries
The UK is made up of four countries and all four countries have left the European Union. However, from a regulatory standpoint, the UK is made up of two territories:
England, Scotland, and Wales = Great Britain. Great Britain requires appointment of a UKRP and registration of devices with the MHRA. Under the current ‘Brexit’ transition period, the MHRA accepts CE Marked devices onto the Great Britain market until 2028-2030 (exact date depends on type of device). Note that acceptance of CE Marking does not exempt companies from appointing a UKRP and registering their 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.
