The Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance on meeting UK medical devices regulations in the development of digital mental health technologies.
The move is aimed at ensuring the technologies are effective, reliable and acceptably safe, and has come in response to the increasing use of mental health apps, AI powered assessments and virtual reality therapy.
MHRA said that manufacturers may be unsure how medical devices regulations apply to software, which products are regulated, how they are assessed, and what evidence is required.
In response, the new guidance explains: how to define and communicate the intended purpose of a digital mental health technology; when a digital mental health technology is considered a medical device under UK law; and how risk classification is determined, ensuring proportionate regulation for different types of technologies.
The agency said this will provide greater confidence for people using mental health apps.
Huge potential
Its deputy director of innovative devices, Rob Reid, 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 that 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 project, funded by the Wellcome Foundation and launched in 2023, to explore the regulation of digital mental health products.
It has been 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.
Assuring safety
Mark Chapman, director of healthtech at NICE, said: “Providing more detailed guidance to the developers of digital mental health technologies helps us to 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 that 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 and 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 whilst also ensuring they are safe, effective and as transparent as possible.”
