The industry still needs clarity on medical device regulations
Late yesterday evening (25 May 2023) the Chancellor of the Exchequer, Jeremy Hunt, unveiled plans to make a package of £650-million available to drive forward the UK’s life sciences sector and help grow the economy.
The package covers 10 different policies, including:
- £121 million to improve commercial clinical trials to bring new medicines to patients faster
- up to £48 million of new money for scientific innovation to prepare for any future health emergencies
- £154 million to increase the capacity of the UK’s biological data bank further aiding scientific discoveries that help human health
- up to £250 million to incentivise pension schemes to invest in our most promising science and tech firms
- plans to relaunch the Academic Health Science Network as Health Innovation Networks to boost innovation by bringing together the NHS, local communities, charities, academia and industry to share best practice
Whilst of course BHTA welcomes extra funding for the industry and is pleased with the commitment to growth of the sector and announcement to cut NHS waiting times, the Association warns that there is still outstanding uncertainty over medical device regulations and this needs to be addressed urgently.
Responding to the life science growth package David Stockdale, Chief Executive of the British Healthcare Trades Association (BHTA) said:
“The BHTA welcomes any new funding for the life sciences sector, however, we are alarmed at how long it is taking to address critical issues of regulatory uncertainty for medical devices. These delays are hugely concerning for industry and patients alike, leading to supply issues and a reduction in investment in the UK. We acknowledge the need for further consultation, but this must be done at pace, in partnership with industry, including the BHTA, to ensure that no further ground is lost.”
The recent Medical Devices (Amendment) (Great Britain) Regulations 2023 aimed to provide the UK medical devices sector with additional time to transition to the post-EU exit UK Conformity Assessed (UKCA) marking regime for medical devices.
However, there are critical points that still require urgent clarification.
The British Healthcare Trades Association represents over 400 UK businesses involved in the design, manufacture, and supply of medical devices. Recent consultations with Association members has shown that the investment and time needed to navigate the current regulatory environment is negatively impacting the supply of vital medical devices to UK patients.
Whilst yesterday’s announcement hopes to improve the regulatory environment for UK Life Sciences companies, BHTA asks that more focus is put on medical devices and how they are being classified and regulated, to help industry and the UK patient.
Notes to the editor
- David Stockdale, Chief Executive Officer of the British Healthcare Trades Association (BHTA) is available for further comment and interview on this subject.
- The British Healthcare Trades Association (BHTA) is a not-for-profit trade association representing over 400 retailers, installers, service providers, distributors and manufacturers in the healthcare and assistive technology industries. For further information please see: https://www.bhta.com/who-we-are/
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Sam joined BHTA in June 2021.
She has worked in the healthcare industry for over 7 years, raising awareness of a range of healthcare products and services.