Regulation of Digital Mental Health Technologies
Spotlight on the new MHRA guidance on the qualification and classification of Digital Mental Health Technologies
As the use of digital tools in the mental health sector grows, so too does the need for clear and risk-proportionate regulation to ensure the safety and effectiveness of devices on the UK market. New guidance on Digital Mental Health Technologies (DMHTs), released by the MHRA in February, is a pivotal output of a 3 year collaborative project between the MHRA and NICE, funded by the Wellcome Trust.
Historically, many DMHTs have sat in a regulatory grey area, particularly under the UK MDR (and EU MDD) definitions. Unsurprisingly, this has led to inconsistency in interpretation and application of the regulations, with a lack of clarity for manufacturers, healthcare providers, clinicians and patients. Some DMHTs have even been removed from the market by the MHRA for failing to demonstrate compliance with the regulations. This new guidance document represents a huge step forwards in supporting developers, healthcare providers, clinicians and patients in understanding the regulation of DMHTs. Beyond mental health, it also provides a potential framework for understanding the MHRA’s approach to the regulation of digital technologies in other clinical areas.
So, let’s take a deep dive into the new guidance:
What is a DMHT?
A DMHT is defined as “digital and software products that support mental health and wellbeing.” This covers a wide range of devices including mobile applications, extended reality, websites and wearable devices. Not all DMHTs will meet the definition of Software as a Medical Devices (SaMD), but those that do must demonstrate compliance to the Medical Device Regulations to access the UK market (the UK MDR 2002 in GB and EU MDR 2017/745 in NI).
How do I know if my DMHT is a regulated medical device?
Step 1: Device Characterisation
The first step is defining the intended purpose (or intended use) of the DMHT. Accurately and succinctly characterising your device is the foundation of understanding its medical device status and applicable regulatory requirements. This new guidance references a previous publication from the MHRA on defining the intended purpose for software as a medical device to support developers in this process. Crucially, anything written in your intended purpose must be backed up by evidence. This can lead to an iterative process of evidence generation and updating the device's intended purpose. However, once on the market, any changes to the intended purpose will require regulation re-certification. Furthermore, your intended purpose must be consistent across all device documentation, including in social media, marketing materials and labelling.
Step 2: Qualification
Determining whether or not a device is considered a medical device has previously been a tricky grey area for many DMHTs. The new guidance splits the qualification process up into these 2 key questions:
Does the device have a medical purpose?
Does the device have sufficient functionality?
If the answer is yes to both of these questions, then the drive is a regulated medical device.
But how do we answer these questions?
Medical purpose
To answer question one the guidance refers back to the regulation. Based on the medical device definition in the relevant regulations, if your device is intended to be used for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease, injury or disability for individual patients it is very likely to be a medical device.
This guidance goes an extra step in providing additional context to this definition for DMHTs. This includes specific terminology suggestive of a medical purpose, and states that DMHTs intended for use “as part of the broad process involved in the management of mental ill health” or “used or recommended as part of any NHS service” are indicative of a medical purpose. This scope therefore encompasses a large variety of DMHTs. It also includes devices that infer a medical purpose in promotional literature or advertising.
Functionality
The next stage is understanding the computational functionality of the device. The guidance split these functions into “low” and “high” functionality, as described below:
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Low functionality = Unlikely SaMD
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High functionality = Likely SaMD
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*This can only be applied if specific criteria are met, including usability investigations proving the ease of verification.
When a DMHT has both a medical purpose and high functionality, it is considered Software as a Medical Device (SaMD).
Medical purpose + low functionality = not SaMD
Medical purpose + high functionality = SaMD
29 different example functions are provided in the guidance document to assist the interpretation for different device functions. For example, an artificial intelligence (AI) ambient listener and consultation summariser is considered high functionality as it processes data using AI. Coupled with a medical purpose, such devices would therefore be considered SaMD.
On the other hand, a device that allows users to respond to a validated mental health monitoring questionnaire and output the results without processing, and has demonstrated ease of verification of the calculation, can be considered low functionality.
Step 3: Regulatory Classification
Classification rules for SaMD are different in the UK and Europe (including Northern Ireland under the NI protocol).
Under the UK MDR (as amended from the EU MDD), many DMHTs SaMD devices are classified under the lowest risk class (Class I), unless they allow direct diagnosis, and may therefore follow the manufacturer self-certification route. In contrast, under the EU MDR regulations, covering the EU and Northern Ireland, the updated rules for software mean that almost all DMHTs are classified as a minimum of Class IIa, and therefore require notified body review.
This guidance is a welcome update on the regulation of DMHTs and provides much needed clarity to developers looking to develop digital technologies for mental health, as well as to buyers, patients and healthcare professionals looking to procure and use these devices. Manufacturers are strongly encouraged to read this guidance, even those not focusing specifically on the mental health space, as it sets a possible precedent for future updates on the MHRA’s interpretation of the regulations in the context of all SaMD.
With another year of the MHRA/NICE collaboration to go, we expect further outputs to be published, including guidance focusing on the evaluation of DMHTs. With planned updates to the UK core medical devices regulations also expected in the near future, developers must ensure they stay up to date with the changing UK regulatory landscape.
Hardian Health is a clinical digital consultancy focused on leveraging technology into healthcare markets through clinical strategy, scientific validation, regulation, health economics and intellectual property.
