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:
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. 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. More information about UKCA marking is provided below.
At this time there is no official UKRP symbol, equivalent to the EC-REP or CH-REP symbols.
Register your devices with the MHRA
The UKRP must submit the registration on behalf of non-UK manufacturers. Once submitted, the MHRA will review basic information about the manufacturer and device. However, the final 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.
Previous Registration Deadlines
- Class III/AIMD/Class IIb Implantable/IVD List A: 1 May 2021
- Class IIb non-implantable/Class IIa/IVD List B/IVD self-test: 1 September 2021
- Class I medical devices/General IVDs/custom-made devices: 1 January 2022
The registration is published on the MHRA’s public access database.
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.
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 regulations take 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 regulations take effect, whichever is sooner
The current UK medical device and IVD regulation is based on the old EU Directives and a new version of the UK regulation has been proposed. The updated UK regulation will be similar to the MDR/IVDR and is expected to go into effect in 2023, Therefore, the MDR/IVDR five-year extension is to 2028, the MDD/AIMDD extension is to 2026 and the IVDD extension is to 2028.
After these dates, companies must have UKCA marking to continue marketing in Great Britain.
What does this mean for me?
Between today and the above dates, 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 Great Britain
2) register your company and device with the MHRA
3) register your UK importer with the MHRA
After the above transition period ends, you must obtain UKCA marking to keep selling in Great Britain.
Northern Ireland, however, will not require UKCA marking. Instead, they will continue to require European CE marking. More information about requirements in Northern Ireland is provided below.
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) 93/42/EEC / In Vitro Diagnostics Directive (IVDD) 89/79/EC. However, the MHRA has proposed major updates, many of which are comparable to the Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostics Regulation (IVDR) 2017/746.
Class I self-certified and general IVDs 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 Conformity Assessment Body. The list of UK approved bodies can be found on the MHRA website, located here.
After the device has been UKCA marked, manufacturers must:
1) apply the UKCA marking symbol to the labeling;
2) add the UK Responsible Person to the labeling, if not located in the UK;
3) sign the UKCA Declaration of Conformity, asserting compliance with the UK regulation; and
4) 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
The United Kingdom is made up of the following four countries: England, Northern Ireland, Scotland and Wales. All of the UK countries collectively left the European Union.
Three of those countries make up Great Britain: England, Scotland and Wales.
Northern Ireland is not part of Great Britain.
Notably, even though all four countries are part of the UK, the regulatory requirements between Great Britain and Northern Ireland will diverge once UKCA marking becomes mandatory.
Northern Ireland requires, and will continue to require, CE marking. This includes the need to appoint an EU Authorized Representative (AR) if the manufacturer is not located in an EU or EEA country. This means that some manufacturers may need to appoint both an EU AR and a UKRP to sell in all UK countries.
Great Britain manufacturers must appoint an EU Authorized Representative and obtain CE marking before placing devices on the market in Northern Ireland.
For more information visit our Knowledge Center page: Northern Ireland Medical Device Requirements