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MHRA Digital Mental Health Technology Guidance
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released new guidance aimed at digital mental health technologies (DMHTs), helping manufacturers navigate regulatory requirements and ensuring these technologies remain safe and effective for users. This guidance is particularly relevant given the growing prevalence of digital health solutions, including mental health apps, AI-driven chatbots, virtual therapy platforms, and other software-based interventions.
This blog post will break down the key points from the newly released guidance, what it means for manufacturers, and how it aligns with broader medical device regulations.
The Need for Regulatory Guidance in Digital Mental Health
The rise of DMHTs has been fueled by increased demand for mental health support, particularly since the COVID-19 pandemic. From AI-powered therapy assistants to cognitive behavioral therapy (CBT) apps, these technologies promise greater access to care. However, their safety and effectiveness have been questioned due to a lack of standardized regulatory oversight.
The MHRA’s guidance seeks to:
- Ensure patient safety by providing clear regulatory pathways.
- Help developers determine if their software qualifies as a medical device.
- Clarify classification rules for different types of DMHTs.
- Set standards for regulatory compliance under UK law.
Key Highlights of the MHRA Guidance
1. What Are Digital Mental Health Technologies (DMHTs)?
According to the guidance, DMHTs encompass a broad range of software and digital products that support mental health and well-being. These include:
- Websites, apps, and digital platforms offering mental health support.
- Technologies integrated with wearables, VR, or other devices.
- AI-driven tools providing diagnosis, monitoring, or treatment recommendations.
Some DMHTs are classified as Software as a Medical Device (SaMD) if they meet certain criteria (discussed below).
2. Determining If a DMHT Is a Medical Device
Determining whether a DMHT qualifies as SaMD is based on the intended purpose and functionality of the device in the labelling, IFU and promotional materials (e.g. websites, social media and adverts) and technical documentation
A DMHT qualifies as a medical device under the UK Medical Devices Regulations (UK MDR) if it:
- Has a medical purpose, such as diagnosis, treatment, prevention, or monitoring of a mental health condition.
- Has sufficient functionality, meaning it processes, analyzes, or interprets data beyond basic storage and communication.
2(a) - Determining Medical Purpose
To further determine "medical purpose", one needs to consider the medical purpose in the context of use. DMHTs considered to have a medical purpose if they are intended as part of the broad process involved in the management of mental ill health.
This includes DMHTs that:
- Help with assessing risk, diagnosing, predicting, monitoring, treating or preventing mental health conditions and / or symptoms
- Where the conditions and / or symptoms are at levels considered diagnosable or clinically relevant
- Are either intended for patients, the public and / or healthcare professionals.
The following examples are given in the guidance to illustrate what is considered a medical purpose:
- NOT a medical device: The following example given in the guidance is considered to be for well-being and does not have a medical purpose
- The product supports treatment of poor sleep. It is only for well-being and when poor sleep would be considered at sub-clinical levels, rather than clinical levels as part of a diagnosable mental health condition. An app providing general well-being advice or educational content on managing stress.
- Medical device (SaMD): Well-being and has a medical purpose -
- An AI chatbot assessing anxiety levels and recommending interventions based on clinically validated scoring systems .
2(a) - Determining Sufficient Functionality
When it comes to determining "sufficient functionality", the guidance divides tasks into low functionality and high functionality, where the former would like not be considered a SaMD and the latter would be considered SaMD. Examples of both are provided below.
- Low Functionality -
- Store data / infomration without change
- Communicate data / information without change or prioritization
- Processes user instructions to show fixed content in a smilar manner to a user choosing a chapter in a digital book, audio book or video
- Processes data / information with an easily verifiable calculation / algorithm
- High Functionality
- Processes user instruction with an interactive and/or personalized output
- Processes data / information with a calculation / algorithm that is not easily identifiable
- Processes data / information using AI
3. Regulatory Classification of DMHTs
Once a DMHT qualifies as a medical device, it must be classified based on its risk level:
- Class I: Low-risk devices (e.g., simple tracking apps).
- Class IIa: Medium-risk devices (e.g., apps recommending personalized treatment interventions).
- Class IIb or III: Higher-risk devices (e.g., AI-based diagnosis tools or technologies influencing direct patient treatment) .
4. Compliance with UK Medical Device Regulations
Manufacturers must ensure compliance with:
- UKCA or CE certification to demonstrate adherence to safety and performance standards.
- Post-market surveillance to continuously monitor safety and effectiveness.
- Cybersecurity requirements, ensuring user data is protected from breaches .
5. Impact of AI and Machine Learning in DMHTs
The guidance provides specific considerations for AI-powered DMHTs, which are increasingly common. These include:
- The importance of transparent algorithms that users and healthcare providers can understand.
- Regular updates and validation to avoid biases in AI-generated recommendations.
- Compliance with AI safety standards under UK MDR and EU MDR .
What This Means for Manufacturers
The new MHRA guidance is a significant step toward regulating DMHTs effectively. Developers and manufacturers should:
- Assess whether their software qualifies as a medical device.
- Determine its classification based on intended use and risk level.
- Ensure compliance with UK regulatory requirements (UKCA certification, post-market surveillance, etc.).
- Address cybersecurity and data privacy concerns.
- Regularly validate AI and algorithm-based recommendations.
Conclusion
The MHRA’s new guidance is a welcome move for ensuring that digital mental health technologies meet high standards of safety and effectiveness. As the digital mental health sector continues to grow, clear regulatory frameworks will help foster innovation while protecting users.
For manufacturers, now is the time to review compliance strategies, adapt products to meet regulatory expectations, and prepare for evolving AI and SaMD regulations.
For more information, read the official press release here and the full MHRA guidance here.
Disclaimer - https://www.cosmhq.com/disclaimer
