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New guidance to ensure that digital mental health technologies are effective, reliable and acceptably safe, has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA).
Digital mental health technologies, such as apps, AI-powered assessments, and virtual reality therapy, are increasingly used by individuals and the NHS to support mental health.
The guidance for manufacturers, published on 3 February 2025, sets out how medical devices regulations apply to software, which products are regulated, how they are assessed, and what evidence is required.
Rob Reid, deputy director of innovative devices at MHRA, said:…