New MHRA guidance on classification of DMHTs as software medical devices

On 3 February 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) released a new guidance document to help manufacturers navigate the regulatory landscape for Digital Mental Health Technologies (DMHTs) in the UK, which includes Great Britain and Northern Ireland. DMHTs are transforming mental health support, encompassing a diverse array of products, from mobile applications to AI-driven chatbots.

This new document is pivotal for determining the characterisation of a DMHT, whether a DMHT qualifies as software as a medical device (SaMD), and how it should be classified under medical device regulations. Overall, the guidance explains how to obtain CE or UKCA certification.

Device characterisation: intended purpose and functionality

Firstly, manufacturers must define the intended purpose and functionality of their DMHTs. This step is critical as it informs risk assessment, evidence generation, and market adoption strategies. The MHRA includes in the guidance a characterisation questionnaire, that aims to aid manufacturers in communicating these details to stakeholders.

Determining qualification as SaMD

DMHT’s qualification as SaMD depends on its intended purpose and functionality, as presented in its labeling, instructions for use (IFU), and promotional materials. This classification requires careful consideration of user understanding and real-world product use. The two key aspects determining if a DMHT qualifies as a SaMD are:

  • If the DMHT has a medical purpose, and
  • If the DMHT has sufficient functionality

The flowchart of this qualification process can be seen below:

source of the image: MHRA

The MHRA guidance further provide clarification, flowcharts, and examples on how a manufacturer can better answer the above two questions.

Determining regulatory classification

If a DMHT qualifies as SaMD, manufacturers must establish its risk classification. This involves applying the relevant rules from the UK MDR, EU MDD, or EU MDR, depending on which compliance path the manufacturer is following. Lower-risk devices (Class I) may be self-certified, while higher-risk devices require a notified body’s assessment.

For more news and updated on medical devices in UK, EU, and Switzerland follow MDlaw, the online regulatory platform on compliance of medical devices.

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