InnoScot Health has backed Scottish Government calls urging NHS and patient voices to be heard in response to a new public consultation on medical device regulations

The UK Government’s Medicines and Healthcare products Regulatory Agency (MHRA) is inviting views on proposed changes to the regulatory framework for medical devices and in vitro diagnostic (IVD) devices in Great Britain, specifically the updating of four policy areas:

• International reliance pathways
• UK conformity assessment (UKCA) marking
• Classification of In Vitro Diagnostic devices
• EU Assimilated law Alignment

MHRA – responsible for ensuring that medical devices are safe and effective for use by patients – is encouraging survey responses from “patients, medical device researchers, developers, manufacturers and suppliers, clinicians, other healthcare professionals and the wider public”.

Following an original consultation undertaken in 2021, the new ‘Medical Devices Regulations: Routes to market and in vitro diagnostic devices’ consultation is intended to be more focused, gathering views on specific policy areas that have changed and developed significantly in recent years.

MHRA says responses to the proposed changes will “support delivery of a regulatory framework for medical devices that prioritises patient safety and improves access to safe, quality healthcare products” while helping to “enable medical innovation”.

The Scottish Government insists that the country’s wide spectrum of healthcare voices must be heard and encouraged to respond.

Kerry Chalmers, Medical Devices Policy and Legislation Head of Unit within the Chief Medical Officer’s Policy Division said: “It is important that the views of the NHS and patients in Scotland are included. Your input can make a difference so please do respond.”

Formal NHS Scotland partner InnoScot Health has backed that focused stance.

Its Head of Regulatory Affairs, Elaine Gemmell stated: “Engaging with the new consultation is vital if our country is to have its say on these small but important reforms to the regulatory framework for medical devices.

“The implications of doing so are significant – the proposed changes contribute to efforts to get safe medical innovation into beneficial usage quicker and in a more transparent manner, help to boost the NHS during this pivotal transformative phase and reduce health inequalities, while providing a platform for fresh economic growth.

“Fundamentally, however, they offer an opportunity to improve how medical devices and IVD devices are regulated in the UK, supported by more information and experience accrued since the first consultation in 2021.

“I would urge all relevant parties in Scotland to have their say. The outcome of the consultation will shape the future Medical Device Regulations, due to be published in draft by Spring next year, and so it is important that you air your views before the 5 January deadline.”