# Digital mental health technology: qualification and classification

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/58d20085-e1e7-45ff-98c0-fd177bcac546
Type: Guidance
Published: February 3, 2025
Updated: July 3, 2025

> This UK MHRA guidance document establishes the regulatory framework for manufacturers of Digital Mental Health Technologies (DMHTs). Rather than citing a specific company or inspection dates, the guidance applies broadly to any entity developing software or hardware intended for mental health support. The primary requirement is for manufacturers to evaluate their product based on intended purpose and functionality. If the device serves a medical purpose with complex functionality, it is classified as Software as a Medical Device (SaMD), necessitating compliance with rigorous safety and effectiveness standards. To avoid regulatory non-compliance, manufacturers must use this guidance to determine their device's risk level, ranging from Class I (low risk) to Class III (high risk). While Class I devices allow for self-certification, Class IIa, IIb, and III devices require independent assessment by approved or notified bodies. Required actions for manufacturers include identifying their product's specific characteristics, ensuring appropriate classification, and obtaining the necessary regulatory certification for the UK or European markets. This proactive approach ensures that AI algorithms, chatbots, and educational modules meet recognized safety standards before being made available to the public.

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## Content

Digital mental health technologies (DMHTs) are software products and related hardware that aim to support mental health and wellbeing. For the purposes of regulation, there are two important characteristics: Intended purpose: what the manufacturer intends it to be used for. For example, whether it is to support wellbeing or to aid treatment of a mental health condition. Functionality: how the product works, and how the different applications of the DMHT are delivered through the device. For example, functionalities can include, but are not limited to, education modules about understanding mental health and wellbeing, AI algorithms and chatbots. If the device is intended to have a medical purpose and the product functionality is considered complex, a DMHT needs to be regulated as a software as a medical device ( SaMD ) product. This means that the manufacturer must meet the requirements of the medical device regulations. They will have to evidence product safety and effectiveness according to recognised standards. This guidance document helps manufacturers identify the specific characteristics of their DMHT and determine whether it is considered as SaMD . If it is SaMD , the guidance will help determine the appropriate device classification. Class I is for the lowest risk medical devices, which manufacturers can self-certify before putting them on the market. Class IIa, IIb, and III are for increasingly higher-risk medical devices and will require approved/notified body assessment to achieve the appropriate regulatory certification in the UK or Europe.

## Attachments

- [Digital mental health technology: device characterisation, regulatory qualification and classification](https://assets.publishing.service.gov.uk/media/6866572fadfe29730ea3a9d5/MHRA_guidance_on_DMHT_-_Device_characterisation_regulatory_qualification_and_classification.pdf)