How to sell your medical devices and 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) guidance document states that appointment of a UK RP is mandatory for non-UK manufacturers 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.
For more information, please read: Role of the UK Responsible Person
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 transitional 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.
For more information, please read: MHRA Medical Device Registration Overview
3) Notify the MHRA of your UK Importer
The MHRA currently does not require that manufacturers appoint an importer in the UK. However, where a manufacturer does have a UK importer, that importer must be registered with the MHRA.
The 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
The MHRA has developed a new conformity assessment process for Great Britain, called UKCA marking.
The MHRA has a transition period in place, which allows companies to market devices based on their CE marking until:
MDR/IVDR CE Marked Devices:
- either the CE certificate expires or
- for five years after the new UK regulation takes effect, whichever is sooner
MDD/AIMDD/IVDD CE Marked Devices:
- either the certificate expires or
- for three years (for general medical devices) and five years (for IVDs) after the new UK regulation takes effect, whichever is sooner
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 2024. If the July 2024 timeframe is met, then the five-year MDR/IVDR/IVDD CE marking extension is to July 2029, the three-year MDD/AIMDD CE marking extension is to July 2027.
After these dates, companies must obtain UKCA marking to continue marketing in Great Britain.
To learn more about the UKCA / CE Marking transition period, please read: UKCA Marking Postponed & CE Marking Transition Period Extended
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:
1) appoint a UK Responsible Person, if you are located outside of the UK
2) register your company and device with the MHRA
3) register your UK importer(s) with the MHRA
After the above transition period ends, you must obtain UKCA marking to keep selling in Great Britain.
NOTE: Northern Ireland will not require UKCA marking. Instead, they will continue to require European CE marking.
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:
- Class I self-certified and general IVD manufacturers to self-affix the UKCA marking.
- Class I sterile/measuring, Class IIa, Class IIb, Class III/AIMD devices and Annex II – List A, Annex II – List B and self-testing IVDs require UKCA marking certificates issued by a UK Approved Body. The list of UK approved bodies can be found: HERE
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.
The UKCA marking symbol can be downloaded from the MHRA’s website: Using the UKCA marking
Important 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 make up Great Britain. Great Britain requires appointment of a UKRP and registration of devices with the MHRA. Further, they will eventually require devices 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 transition period dates are outlined: HERE
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. However, a UKRP and device registration with the MHRA may still be required for Northern Ireland in some situations.