On January 31, the UK left the EU. Preparations are currently underway to ensure that a satisfactory agreement is reached with the EU, following the end of the transition period ending on 31 December. On September 1, the UK government released new post-Brexit transition guidelines on the regulation of medical devices.
From January 1, 2021, the Medicines and Health 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 have a grace period of four to 12 months to comply with the new registration process, depending on the risk of the device, when high-risk devices require prior registration. Manufacturers based outside the UK will need to appoint a UK responsible person to register devices with the MHRA in accordance with the grace periods.
In the United Kingdom (England, Scotland and Wales), all medical devices will require a UKCA (UK Conformity Assessed) mark by July 1, 2023. CE marks issued by notified bodies in the EU will remain valid until this period. However, the UKCA mark alone will not be recognized in the EU. The MHRA will gain the power to designate approved bodies in the UK by assessing whether products meet the requirements of the UKCA mark. 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 market in Northern Ireland (NI) will be different from those in the United Kingdom. CE Marking will remain a permanent requirement and EU Medical Device Regulations (MDR) / In Vitro Device Regulations (IVDR) will apply in this region. In addition, a new conformity mark, UKNI, will be required to place products on the NI market. Under this mark, companies that use a UK body to perform the mandatory third party conformity assessment must apply a UKNI alongside a CE mark. NI may place qualifying products (products made into NI) in the UK market based on conformity marks already used in NI. The table below summarizes the list of scenarios as well as the accepted markings.
These new regulations could have an impact on the number of medical devices approved in the coming years. According to GlobalData’s pipeline product database, more than 17,000 active medical devices are currently under development, of which approximately 42% are in the early stages of development. The high proportion of products under development in the EU and UK indicates that a large majority of devices will be caught in transition approval processes, which may result in a temporary drop in the volume of approved devices .
Many companies are already struggling with MDR / IVDR requirements such as rising costs. This, together with the additional clearance process required to reach the UK market, can cause delays or deter companies from selling their products in the UK.