Regulations for VR/XR in mental health
Extended reality (XR) for healthcare has been growing in popularity in recent years. Some tools have even made it to the mainstream media, such as Virtual Reality (VR) headsets being used to calm patients during minor operations in NHS hospitals. Common use cases include in pain management, surgical planning and mental health applications.
From a regulatory perspective, extended (XR) medical devices, including mixed, augmented and virtual reality, are not explicitly mentioned in the UK regulations. However, depending on their intended purpose they could still be considered medical devices. It’s simplest to consider these devices like any other medical device software, just being accessed through a different device. For example, a VR headset instead of a smartphone. In fact, there are several XR medical devices already on the market in the UK and EU.
In the US, the FDA has published some guidance for patients and healthcare professionals on XR devices in healthcare, alongside a public list of approved XR/VR medical devices on the US market. However, given the novelty of XR devices in healthcare, there is a recognised lack of information for XR innovators wanting to understand medical device regulations. This is a knowledge gap we are helping to close!
The Hardian team has had the pleasure of supporting Innovate UK’s Mindset Extended Reality (XR) for digital mental health programme over the last 6 months, as part of Health Innovation Network (HIN) South London’s consortium of experts. We have developed a series of 10 e-learning modules covering the basics of medical device regulations for innovators in the XR space. We created these bespoke modules to break up the key topics we think innovators should get to grips with into bite-size chunks. The team at HIN is now hosting the modules on a public platform, available in video/audio format as well as written content and interactive multiple choice questions. Our regulatory modules will soon be joined by further modules on Clinical Evidence and Lived Experience involvement, developed by consortium partners.
We have loved being involved in the UK-wide series of roadshow events this summer, with Hardian team members attending both the London and South West events in person, and pre-recorded presentations at all the other events. We enjoyed meeting the innovators and other experts in this space and getting to try out some of the products!
Dr Felicity Lock (Associate, Hardian Health) speaking at the South West Roadshow event.
Mindset Extended Reality (XR): Digital Therapeutics for Mental Health
Innovate UK recently announced Round 2 programme winners, with funding worth £3.2m across 24 fantastic projects developing immersive digital mental health therapeutics. A list of the 24 promising innovations selected can be found on the Innovate UK website. Applications for Round 3 have also just been announced, with the competition opening on the 28th October 2024.
Dr Hugh Harvey (Managing Director, Hardian Health) speaking at the London Roadshow event.
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Developing an XR/VR product and not sure if it’s a medical device? Get in touch!
