On 31 January, the UK left the EU. Preparations are currently taking place to ensure that a satisfactory arrangement is reached with the EU, following the transition period ending on 31 December. On 1 September, the UK Government released new post-Brexit transition guidance on medical device regulations.
From 1 January 2021, the Medicines and Healthcare Products Regulatory Agency (MHRA) will be responsible for the UK medical device market. The new regulations will require medical devices of all classes to be registered with the agency. Manufacturers will be given a grace period of four to 12 months to comply with the new registration process, depending on the risk of the device, where higher-risk devices require an earlier registration. Manufacturers based outside the UK will need to appoint a UK Responsible Person to register devices with the MHRA in line with the grace periods.
In the UK (England, Scotland, and Wales), all medical devices will require a UKCA (UK Conformity Assessed) mark by 1 July 2023. CE marks issued by EU notified bodies will remain valid until this period. However, UKCA marking alone will not be recognised in the EU. The MHRA will gain the power to designate UK approved bodies by assessing if products meet the UKCA mark requirements. Existing UK notified bodies currently designated under EU directives will automatically become UK approved bodies on 1 January 2021 without having to undergo new designation processes.
The rules for placing medical devices on the Northern Ireland (NI) market will differ from those in the UK. The CE marking will be a continued requirement and the EU Medical Device Regulations (MDR)/In Vitro Device Regulations (IVDR) will be applicable in this region. Additionally, a new conformity marking, UKNI, will be required for placing products in the NI market. Under this marking, companies that use a UK body to carry out the mandatory third-party conformity assessment must apply a UKNI alongside a CE mark. NI can place qualifying goods (products processed in NI) in the UK market based on the conformity markings already used in NI. The table below summarises the list of scenarios along with the accepted markings.
These new regulations could potentially impact the number of approved medical devices in the next few years. According to GlobalData’s pipeline products database, there are over 17,000 active medical devices currently in the pipeline with approximately 42% of these devices in the early stages of development. The high proportion of products being developed in the EU and UK indicates that a vast majority of devices will be caught in transitioning approval processes, which may lead to a temporary decline in the volume of approved devices.
Many companies are already struggling with the demands of the MDR/IVDR such as the increased costs. This coupled with the additional authorisation process required to reach the UK market may lead to delays or deter companies from selling their products in the UK altogether.