With ongoing negotiations over a trade deal between the UK and the EU and less than 30 days until the end of the Brexit transition period, the UK Government continues to flesh out guidance on how it will regulate medical devices. It is likely, given the current circumstances, that the Brexit transition period will end without a trade deal in place on December 31st.
Post- Brexit Transition Guidance in Brief:
On September 1st, the UK Government released new post-Brexit transition guidance on medical device regulations, wherein the Medicines and Healthcare products Regulatory Agency (MHRA) states that it will develop its own system after careful consideration of international standards and global harmonization.
From January 1st 2021, the MHRA will assume responsibility for the UK medical device market. In accordance with the new regulations, medical devices of all classes must be registered with the agency.
Depending on the risk of the device, manufacturers will be given a grace period of 4 to 12 months to comply with the new registration process, where higher-risk devices require an earlier registration.
A UK Responsible Person must be appointed by manufacturers outside the UK to register devices with the MHRA in line with the grace periods.
CE marks issued by EU notified bodies will remain valid until July 1st 2023, post which all medical devices in the UK (England, Scotland, and Wales) will need a UKCA (UK Conformity Assessed) mark. However, UKCA marking alone will not be recognized in the EU.
Post an assessment of whether the products meet the UKCA mark requirements, the MHRA shall have the authority to designate UK approved bodies.
UK notified bodies, currently designated under EU directives, will automatically become UK approved bodies from January 1st 2021 without having to undergo new designation processes.
Earlier this fall, UK regulators provided important guidance to medical device manufacturers regarding placing a product on the EU, Great Britain or Northern Ireland markets starting January 2021. The MHRA offered new details on Northern Ireland in a recent update as follows:
Northern Ireland (NI):
Under the terms of the withdrawal agreement, Northern Ireland is treated differently than the rest of the countries that make up the UK. Since Northern Ireland shares a land border with an EU country, the Republic of Ireland, there was a potential for Brexit to create a hard border between the Irish nations, leading to a potential threat to peace (since the 1998 Good Friday Agreement).
Under an arrangement known as the Northern Ireland protocol, goods will not need to be checked along the Irish border when the new UK-EU relationship begins, on January 1st 2021.
This protocol will remove the need for checks on goods travelling from Northern Ireland (a non-EU country) into the Republic of Ireland (an EU country).
In order to eliminate the need for checks, under the protocol, Northern Ireland will continue to enforce the EU’s customs rules and follow its rules on product standards (known as the single market on goods).
Thus, Northern Ireland will keep one foot in the EU, creating the potential for checks on goods coming from other parts of the U.K.
There are different rules to place medical devices on the Northern Ireland (NI) market when compared to the UK. Similar to the EU, the CE marking and the EU Medical Device Regulations (MDR)/In Vitro Device Regulations (IVDR) will be a continued requirement and applicable in this region.
With regards to conformity assessment, a new conformity marking, UKNI, will be required for placing products in the NI market. Here companies that use a UK body for the mandatory third-party conformity assessment must apply a UKNI mark alongside a CE mark. Qualifying goods (products processed in NI) can be placed by NI in the UK market based on the conformity markings already used in NI.
However, the EU will not recognize the UKNI mark and typically devices placed on the EU market must carry a CE mark only.
Devices sold in England, Scotland and Wales will need a different mark, UKCA, although these countries will continue to accept CE marks until the end of 2021.
Devices with the CE and UKCA markings can be launched in the EU market.
Post the transition period, registration with the MHRA is required for certain medical devices, including in vitro diagnostic medical devices (IVDs), placed on the Northern Ireland market.
Beginning January 1st 2021, registration is required for Class I devices and general IVDs placed on the market by Northern Ireland manufacturers and Authorised Representatives based in Northern Ireland. Other device classes will be provided a grace period for registering as follows:
- Class IIIs and Class IIb implantables, and all active implantable medical devices and IVD List A products: registered from May 1st 2021
- Other Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs: registered from September 1st 2021
- Great Britain-based manufacturers must appoint an EU or Northern Ireland-based Authorised Representative when placing devices on the Northern Ireland market,
It is likely that the new regulations will significantly affect the number of approved medical devices available in the near future. Global Data’s pipeline products database shows that there are over 17,000 active medical devices currently in the pipeline with approximately 42% of these devices in the early stages of development. With a vast majority of devices being developed in the EU and UK, many will be caught in transitioning approval processes, leading to a temporary decline in the availability of approved devices.
Several companies are already struggling to meet the demands and requirements of the MDR/IVDR leading to increased costs. Coupled with the additional authorisation processes required to reach the UK market, this may lead to delays or deter companies from selling their products in the UK altogether. Companies who would like to place their devices on both the UK and EU market must continue to track the changes in regulations and prepare for region specific registration requirements, perform conformity assessment processes in a timely fashion, and allocate adequate budgets for the transition.