• 60% of respondents expected the marketing of devices to be more difficult as all manufacturers will need to register with the Medicines and Healthcare Products Regulatory Agency (MHRA)
• Additional regulatory authorization to enter the UK market might deter companies

• Despite new UK regulations, the UK medical device industry is predicted to reach $19.8 billion by 2030

The Brexit transition is adding to the piles of paperwork and costs burdening the medical device industry, according to GlobalData, which expects that regulatory hurdles will disrupt the approval of existing and new devices and technology. For example, the leading data and analytics company reveals that 60%* of medical device industry professionals responding to a survey said they foresee the marketing of devices to be more difficult.

Selena Yu, Medical Devices Analyst at GlobalData, comments: “The approval and marketing processes of new medical devices are expected to become more complex and lengthier because manufacturers need to follow both EU and UK regulation. In the end, companies will need to increase spending to release and market new products to the UK. This additional barrier may simply deter companies from selling their medical devices in the region, as they turn instead to focus on the already established EU relationship.”

Some of the regulations causing the industry a headache include the need to register products with the Medicines and Healthcare Products Regulatory Agency (MHRA), and submit subsequent reports to the agency; that all new medical devices in the UK will require a UK Conformity Assessed (UKCA) mark; and many companies are finding difficulties meeting the increased costs of the new EU regulations Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).

According to GlobalData’s latest report, ‘Thematic Research: Brexit Impact on Medical Devices’, the UK medical device industry is still expected to see growth, despite these challenges—reaching $19.8 billion by 2030. Additionally, the IVDR changes do not appear to have hindered the in vitro diagnostics segment in 2020, as this medical device sector accounted for 15% of total revenue.”