The Medicines and Healthcare products Regulatory Agency has issued new advice for people using or recommending mental health apps and other digital tools, with free resources hosted on NHS England’s MindEd programme. The materials were published on 27 January 2026 and updated on 28 January 2026. (gov.uk)
The guidance is positioned for the public as well as health, social care and education professionals and is delivered as short, accessible learning within MindEd. The programme page confirms the MHRA–NICE collaboration and notes the resources were created in January 2026. (minded.org.uk)
MHRA’s explainer sets out five checks to apply before using a digital mental health tool: be clear on what the product claims to do; confirm who it is designed for; look for evidence that it works; understand how personal data are handled; and establish whether it is regulated as a medical device. Tools that claim to diagnose, treat or manage conditions should explain their evidence clearly and typically carry CE or UKCA marking. (gov.uk)
Where a product qualifies as a medical device, users and organisations can verify UK registration using the MHRA Public Access Registration Database (PARD). The legal framework is the UK Medical Devices Regulations 2002, which define medical devices, set risk classes and describe conformity assessment leading to UKCA marking. (gov.uk)
Safety concerns with regulated digital mental health products should be reported to the MHRA Yellow Card scheme in England, Wales and Northern Ireland. In Scotland, healthcare professionals should report via Health Facilities Scotland’s IRIC. Medical device incidents cannot be reported by telephone; people without online access can email aic@mhra.gov.uk. (gov.uk)
MindEd’s Digital Mental Health Technologies content includes practical tip sheets developed with MHRA and NICE, aimed at helping users and professionals scrutinise claims and find appropriate escalation routes for concerns. This activity sits within a Wellcome-supported programme focused on safer, more effective digital mental health technologies. (minded.org.uk)
MHRA notes that the resources are designed to support informed conversations between clinicians and patients and to emphasise that digital tools complement, rather than replace, professional care. (gov.uk)
The move aligns with wider policy reform. Under the government’s Ten Year Health Plan, NICE will extend technology appraisals from April 2026 to selected devices, diagnostics and digital products, bringing mandated NHS funding and a more consistent national route to adoption. NICE confirms the expanded evaluations will place health technologies on a firmer footing alongside medicines. (gov.uk)
For developers and commissioners, the regulatory expectations are clear. Define intended purpose precisely, decide whether the product is software as a medical device, and generate clinical evidence consistent with UK MDR 2002 and NICE’s Evidence Standards Framework. MHRA’s 2025 guidance on digital mental health technologies explains when mental health tools qualify as medical devices and how risk class affects the need for Approved/Notified Body assessment. (gov.uk)
For schools, GP practices and NHS providers that signpost to apps, practical steps include confirming any device registration on PARD, checking that evidence matches the stated claims and intended users, and ensuring staff know how to escalate issues through Yellow Card or IRIC. The MindEd modules provide a straightforward starting point for local digital mental health signposting policies. (gov.uk)