The UK must harmonise with EU regulation on medical devices and address the country’s research funding shortfall post Brexit, or risk losing billions of pounds worth of export opportunities and thousands of jobs, according to a new report by the Institution of Mechanical Engineers.
The Medical Devices & CE Marking –the Impact of Brexit report calls on the UK Government to negotiate a compliancy agreement with the EU on Medical Technology, in order to ensure continuity with the EU CE marking process, which allows for the export of medical devices and equipment.
Not only does this industry make a huge contribution to domestic and international healthcare - from the design of artificial joints and organs through to the production of aids for independent living - the sector is also worth £17billion to the UK economy and supports 90,000 jobs
The report also calls for greater clarity on how UK Research and Innovation will address the more than €1billion a year funding shortfall the UK faces once it is no longer eligible for European Research Council funding.
According to the report, ensuring the UK can continue to innovate and export is vital for the UK medical technology sector.
Dr Helen Meese, the institute’s head of healthcare, said: “The UK Government must ensure that the Med Tech industry is high on its priority list as it prepares to negotiate the country’s departure from the EU.
“Not only does this industry make a huge contribution to domestic and international healthcare - from the design of artificial joints and organs through to the production of aids for independent living - the sector is also worth £17billion to the UK economy and supports 90,000 jobs.
As part of the UK’s Brexit deal, it is vital the UK is able to maintain continuity with the EU CE certification processes and enable UK manufacturers to export medical devices into the €100billion European Med Tech market
“Leaving the EU without the UK medical technology industry suffering considerable long-term damage, particularly for small businesses, will be a huge challenge.”
She added: “As part of the UK’s Brexit deal, it is vital the UK is able to maintain continuity with the EU CE certification processes and enable UK manufacturers to export medical devices into the €100billion European Med Tech market.
“Our Government should not forget to use the purchasing power of the NHS to help attract new business into the sector and retain influence over future European regulation.
“The Government also needs to outline exactly how UK Research and Innovation bodies such as InnovateUK and the Engineering and Physical Sciences Research Council will address the more than €1billion a year funding shortfall from what the UK currently receives from the European Research Council.”
The institute’s report makes three key recommendations:
- That the Government negotiates a Med Tech compliancy arrangement with the EU to ensure continuity in the CE marking process for UK manufacturers. This arrangement should be supported by parallel policies to encourage long-term investment in the sector. The goal is to attract Med Tech SMEs to the UK through clear support for innovation and product development
- That UK industry and the NHS should work together to ensure that they retain influence over future European regulation. This influence could flow from the purchasing power of the NHS, but should also be based on more-formal post-Brexit arrangements negotiated by the UK Government on its behalf
- That UK Research and Innovation must address the EU funding shortfall. This must take the opportunity to remove the current imbalance in support between early-stage start-ups and large established companies. A full commitment to implementing the Accelerated Access Review would go a long way to addressing this
Click here to read the full report.
