New guidance has been published by the Medicines and Healthcare products Regulatory Agency (MHRA), focusing on developing safeguards, regulation and evaluation for UK digital mental health technologies including mental health apps, AI-powered assessments, and virtual reality therapy.
It notes that “some DMHTs qualify as software as a medical device (SaMD), and must comply with relevant medical device regulations,” with the guidance providing information on defining the intended purpose and functionality, determining qualification as software as a medical device, and determining regulatory classification. Here, the guidance raises questions such as does the DMHT have a medical purpose, does it have sufficient functionality, does it perform a clinical task, or target clinical conditions and symptoms.
On determining whether the technology is a medical device, the guidance notes the requirements on the manufacturer for wider adoption. It details the need for continuous post-market surveillance activities, for all product changes to be documented, and for adequate information to be provided to enable patients, the public and professional users to understand the intended purpose, associated risks and evidence.
According to the guidance, in order for a product to qualify as an SaMD, manufacturer’s must be able to demonstrate that their device has a true medical purpose with the ability to diagnose, prevent, monitor, treat or alleviate disease or injury; investigate, replace or modify of the anatomy, or physiological process; or control conception. It adds that “DMHT are considered to have a medical purpose if they are intended as part of the broad process involved in the management of mental ill health”. This covers assessing risk, diagnosing, predicting, monitoring, treating or preventing mental health conditions and or symptoms.
The MHRA also notes that technology “must meet medical device standards to ensure they are safe” and that “manufacturers of digital mental health technologies should review the guidance to ensure compliance before bringing their products to market”.
Rob Reid, deputy director of innovative devices at the MHRA, 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.”
Learn all the details about the guidance here.
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