The MHRA said: “From mental health apps and AI-powered assessments to virtual reality therapy, digital mental health technologies are increasingly being used by individuals and the NHS to support mental health. Digital mental health technologies that diagnose, prevent, or treat conditions using complex software must meet medical device standards to ensure they are effective and acceptably safe, just like any other medical device. Manufacturers may be unsure how medical devices regulations apply to software, which products are regulated, how they are assessed, and what evidence is required.”
The new guidance thus explains:
- How to define and communicate the intended purpose of a digital mental health technology.
- When such a technology is considered a medical device under UK law.
- How risk classification is determined, ‘ensuring proportionate regulation for different types of technologies’.
For people using mental health apps, the MHRA says this ‘means greater confidence in the tools they rely on’.
Rob Reid, the Agency’s Deputy director of Innovative Devices (pictured), said: “Effective and acceptably safe digital tools have huge potential to improve mental health support, making help more accessible than ever. This new guidance aims to support safe access to these important tools by clarifying when a product needs regulatory approval and the steps developers must take. Maintaining clear and proportionate regulatory standards will ensure the public can trust these technologies and benefit from the safe, effective, mental health support they can provide.”
The guidance is one of the outputs from a three-year Wellcome-funded project, launched in 2023, to explore the regulation of digital mental health products. Developed by the MHRA, with input from the National Institute for Health and Care Excellence (NICE), NHS experts, researchers, healthcare professionals, and people with lived experience, it aims to meet both clinical and real-world needs, to address the growing mental health crisis in the UK.
Mark Salmon, Deputy director of Science Evidence and Analytics at NICE, said:
Providing more detailed guidance to the developers of digital mental health technologies helps us ensure that technologies being considered for NICE assessments have received an appropriate level of regulatory scrutiny to assure their safety. There are many types of technologies available, and it is important people can understand how regulations apply to different products. This guidance will help inform our evaluations, and ensure NICE is able to publish useful, usable, and timely guidance that allows people with mental health conditions to access safe and effective innovations faster.”
Professor Miranda Wolpert, director of Mental Health at Wellcome, which funded the project, said: “With millions of people around the world held back by mental health problems, digital mental health therapies have huge potential to be scalable and accessible.
“It is not easy to navigate between over and under-regulation in this area. In a fast-moving, continuously evolving digital space, these thoughtful guidelines appear well-positioned to strike a pragmatic balance between making digital mental health technologies accessible to those with a range of mental health needs, and ensuring they are safe, effective, and as transparent as possible.”
The full guidance, Digital mental health technology: qualification and classification, is available on the MHRA website.