Medical and Healthcare Products Regulatory Agency (MHRA) has released new guidance to help manufacturers meet UK medical regulations
This new guidance will ensure that mental health technologies are effective, reliable and safe.
With people who struggle with mental health continuously relying on mental health apps, including AI-powered assessments and virtual reality therapy, these medical devices must meet the correct standards.
Digital mental health technologies
Digital mental health technologies can be used to diagnose, prevent or treat conditions. They do this by utilising complex software that must meet medical device standards.
The new guidance explains to manufacturers how medical device regulations apply to software, which products are regulated, how they are assessed and what evidence is required.
The three main points in the guidance include;
- How to define and communicate the intended purpose of a digital mental health technology
- When a digital mental health technology is considered a medical device under UK law.
- How risk classification is determined, ensuring proportionate regulation for different types of technologies.
By following these guidelines, the people who use mental health apps will have greater confidence in the tools they rely on.
One of the main challenges in regulating digital mental health technologies is distinguishing between products requiring medical device regulation and those that do not.
The guidance defines the intended purpose of a product, helping developers determine whether their technology qualifies as a medical device. Suppose a product is intended to diagnose, treat, or prevent a mental health condition. In that case, it is more likely to be subject to medical device regulations, just like traditional healthcare tools.
This distinction is crucial because it determines how the technology will be regulated, its scrutiny level, and the type of evidence required to demonstrate its safety and effectiveness. For example, low-risk digital tools that offer general mental wellness support may not require the same rigorous approval processes as high-risk devices intended for diagnosing or treating mental health conditions.
MHRA guidance
To further help developers, the MHRA guidance outlines a risk classification system.
This system categorises digital mental health technologies into various classes, from low-risk Class I devices, which can be self-certified by manufacturers, to higher-risk Class IIa, IIb, or III devices that require a more in-depth assessment by an external regulatory body.
This system ensures that the regulation applied is proportionate to the level of risk set by the technology, making it easier for developers to comply and ensuring that consumers are protected.
The guidance also addresses the importance of evidence in developing these technologies. Developers are, therefore, encouraged to provide data showing their products’ effectiveness and safety.
In the context of digital mental health tools, this may include evidence from clinical trials, user feedback, or real-world use cases that show the product is safe and effective in improving mental health outcomes.
Reassuring mental health patients through technology
The new guidance offers reassurance for end-users, such as individuals looking for mental health support or healthcare professionals integrating these technologies into care plans.
By clarifying regulatory requirements and ensuring that only those products that meet specific standards are available, it looks to improve trust in digital mental health tools.
It also ensures that users get access to technologies that can truly help manage and improve mental health conditions, with the added benefit of knowing that these tools have been tested for safety and efficacy.
As digital mental health technologies evolve, the regulatory framework must keep up with innovation. The MHRA’s guidance represents an important step in balancing the need for accessibility with the need for oversight, ensuring that mental health products are both effective and safe.
