Business secretary Kwasi Kwarteng has set out the UK's ambition to develop a leading regulatory environment for both medical devices and in-vitro diagnostics.
In a letter to Cathryn Ross, chair of the Regulatory Horizons Council, Kwarteng responded a series of recent recommendations made by the council with regards to the UK's medical devices regulatory framework.
The Medicines and Healthcare products Regulatory Agency will shortly begin consulting on this framework, with members of the Department of Health and Social Care set to respond to Ross following the consultation's conclusion.
Kwarteng explained that while the UK aims to have a "best-in-class" regulatory environment, it must avoid becoming complacent.
"The UK’s aim is to have a best-in-class regulatory environment for both medical devices and in-vitro diagnostics," he wrote.
"Whilst the MHRA is already recognised as a global leader, we cannot be complacent and must use the opportunity of leaving the EU to deliver a best-in-class regulatory system for the UK. The regulatory response to COVID-19 demonstrated the speed and flexibility with which the UK system can act."
Kwarteng added that he agreed with the assertion by the council that the UK must prioritise both innovation and patient safety.
"We need to continue to act with pace to realise the opportunity to set world-leading regulatory standards in areas of rapid innovation," he said.
I agree with the Council that there are substantial opportunities for the UK for medical devices and that we will need to ensure a proportionate regulatory approach to support both innovation and drive patient safety."
Oval Medical Technologies is a leading designer of medical devices, specifically autoinjector platforms.
With a patient-centric approach, it designs from the outside in that are quality system compliant to BS EN 13485:2016.
Founded in 2009, Oval Medical Technologies was acquired by SMC Ltd in 2016, a partnership that has ensured reliability in product performance and a fast route to market.
