- 60% of respondents expected bringing devices to market would be more difficult as all manufacturers will need to register with the Medicines and Healthcare Products Regulatory Agency (MHRA)
- Additional regulatory clearance to enter the UK market could deter businesses
- Despite new UK regulations, the UK medical device industry is expected to reach $19.8 billion by 2030
The Brexit transition adds to the piles of paperwork and costs weighing on the medical device industry, according to GlobalData, which expects regulatory hurdles to disrupt the approval of existing and new devices and technologies. For example, the leading data and analytics firm reveals that 60%* of medical device industry professionals who responded to a survey said they anticipated bringing devices to market would be more difficult.
Selena Yu, Medical Devices Analyst at GlobalData, comments: “The approval and commercialization processes for new medical devices are expected to become more complex and time-consuming as manufacturers must comply with both EU and UK regulations. Ultimately, companies will need to increase spending to launch and market new products in the UK. This added hurdle may simply deter companies from selling their medical devices in the region, as they look instead to the already established relationship with the EU.
Some of the regulations causing industry headaches include the requirement 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 struggling to cope with the increased costs of the new European Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).
According to the latest GlobalData report, ‘Thematic research: impact of Brexit on medical devices‘, the UK medical device industry is still expected to grow, despite these challenges, reaching $19.8 billion by 2030. Additionally, IVDR changes do not appear to have hampered the in-diagnostics segment. vitro in 2020, as this medical device sector accounted for 15% of total sales.