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 (Med Tech), in order to ensure continuity with the EU CE marking process, which allows for the export of medical devices and equipment. The report also calls for greater clarity on how UK Research and Innovation will address the more than €1bn 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, head of healthcare at the Institution of Mechanical Engineers, said: “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 £17bn to the UK economy and supports 90,000 jobs.
“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.
The IMechE says in its report that it is vital, as part of the UK’s Brexit deal, that the UK can maintain continuity with the EU CE certification processes, and enable UK manufacturers to export medical devices into the €100bn European Med Tech market.
The institution also calls upon the Government to use the purchasing power of the NHS to help attract new business into the Med Tech sector and retain influence over future European regulation. Additionally, the Government 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 €1bn a year funding short-fall from what the UK currently receives from the European Research Council.
The Medical Devices & CE Marking –the Impact of Brexit, makes three key recommendations:
- 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.
- 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.
- UK Research and Innovation must address the EU funding short-fall. 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.
