RegulatoryOfficial

MHRA and NICE seek feedback on digital mental health technology resources

🇬🇧 MHRA · Thu 05 Nov 2026

A survey open until 26 February 2027 asks developers, clinicians, researchers and the public how Phase 1 resources from the Wellcome-funded DMHT programme have been used.

The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have opened a call for evidence on the resources produced under the Wellcome Digital Mental Health Technologies (DMHT) programme. The survey was published on 5 November 2026 and closes at 11:59pm on 26 February 2027.

According to the MHRA, the resources were created to support the safe development, regulation, evaluation and use of digital mental health technologies, including mental health apps and other digital tools. The survey forms part of a Phase 1 process and theory-based outcome evaluation of the programme.

The agencies want to learn how the resources have been received, accessed and used. They also want to know whether the materials have changed people's understanding, confidence, decision-making and professional practice. The findings will be used to judge whether Phase 1 outputs are meeting their objectives and to shape the MHRA's and NICE's direction in Phase 2 of the programme.

Respondents are invited from a broad range of groups: developers and manufacturers, healthcare professionals, researchers, policymakers and regulators, and people with lived experience of mental health conditions, carers and members of the public. Familiarity with the resources is not required, and the survey length varies because only questions relevant to each respondent are displayed. Responses are submitted online.

The notice sets out no new regulatory requirements. Software and apps can fall under medical device regulation where they have a medical purpose, which is why the programme's work is relevant to manufacturers in this area.

What it means for your team

  • Manufacturers of digital mental health tools can use the survey to give feedback that may influence Phase 2 of the DMHT programme.
  • Regulatory teams should check whether they have used the Phase 1 resources, as the evaluation asks about their practical effect on decision-making and practice.
  • The call introduces no new obligations, but it signals that further MHRA and NICE work on this area is planned.
  • The deadline is 11:59pm on 26 February 2027.

Official source: MHRA ↗

Article written by VigiEye from the official source (MHRA). AI-assisted; check the source before acting.

More Regulatory All →