Digital Technology Innovation and Medical Devices

UK proposes £3.5 billion of funding and innovative new device pathways for Medical Devices and Digital Health incorporating Artificial Intelligence

The UK government is currently looking at reforming the UK regulatory system for medical devices, to increase the agility and ability for innovative software based medical devices and digital health products to regulatory clearance and initial market access in the UK.

As part of this a new regulatory approach will be taken focusing on the applications of AI rather than setting rigid rules for products with an AI component. For medical devices and digital health products, a new AI sandbox has been proposed to supporting innovators in getting their cutting-edge products to market without being blocked by the usual rules. The proposals also include the ability for companies to leverage existing medical device regulatory approvals in trusted markets, such as USA, EU and Japan to gain fast track access to the UK market. This builds upon the UK Software and AI as a Medical Device Change Programme Roadmap which sets out an ambitious programme of innovation supporting regulatory steps to get new products to market quicker, with post market assurance measures to monitor and confirm safety and performance of the devices meet expectations.

Within a science and innovation drive, the UK government will be allocating £3.5 billion in funding for science and technology, including life sciences. One of the funded programmes is an Innovation Accelerator to develop new medical technology. Within the new funding announced, a £10 million package has also been allocated specifically to support and develop AI-based therapeutics for mental health conditions.

IMed Consultancy has developed a position with specialisms in Software as a Medical Device, Digital Health and other high tech regulated products and will be ready to support manufacturers in applying the new UK innovation pathways going forwards, to get their products approved and in clinical use.

References:

Guidance, Software and AI as a Medical Device Change Programme – Roadmap, 17 October 2022

Press release, Government commits up to £3.5 billion to future of tech and science, 16 March 2023

Press release, MHRA to receive £10m from HM Treasury to fast-track patient access to cutting-edge medical products, 15 March 2023

Pro-innovation Regulation of Technologies Review Report – Digital Technologies, March 2023

HM Government Response to Sir Patrick Vallance’s Pro-Innovation Regulation of Technologies Review – Digital Technologies, March 2023,