A Wellcome Development for SaMD – the UK Publishes Guidance on Digital Mental Health Technologies

The MHRA and NICE published guidance on “Digital mental health technology: qualification and classification” (the DMHT Guidance) last week. It was developed as part of a Wellcome funded project on digital mental health technologies (DMHTs). The DMHT Guidance is the latest guidance from the MHRA in the software as a medical device (SaMD) space. 

Interestingly, on the question of qualification of DMHTs, the MHRA will consider both the intended purpose and the functionality of a technology. The DMHT Guidance states that products with so called “low functionality” will not qualify as a medical device, even if they are intended for a medical purpose. The MHRA has provided a large number of worked examples to help industry apply its rules. 

Although this guidance focuses on DMHTs, the MHRA will almost certainly apply the principles to all SaMDs. This focus on functionality in the qualification of SaMDs suggests the MHRA’s approach to SaMD may diverge from the EU’s approach. This may make the UK a good place to launch software products. 

What is a DMHT?

DMHTs are “digital and software products designed to support mental health and wellbeing” (emphasis added). These could include websites, internet-based platforms and apps used in general “non-medical” technologies (e.g., in computers and fitness wearables) or in medical devices. 

DMHTs may qualify as medical devices. Therefore, to ensure a product is correctly regulated, the DMHT Guidance reminds legal manufacturers to: 

• characterise the DMHT;
• ask if the DMHT qualifies as a medical device; and if so,
• determine the classification of the device.

How do I Characterise my DMHT?

Device characterisation requires a legal manufacturer to define: (1) the intended purpose of the technology; and (2) it functionality. There is existing MHRA and international guidance on drafting intended use statements and characterisation that are referenced. The DMHT Guidance notes that characterisation is not only important for the question of whether a technology is a medical device, but is also relevant for risk assessment, evidence generation and market adoption. 

Does my DMHT Qualify as a SaMD?

Under the definition of “medical device” in applicable UK and EU medical device legislation, a technology will qualify as a medical device if it is intended by its legal manufacturer for a medical purpose. The applicable definitions of medical device set out lists of medical purposes. For example, the UK’s Medical Devices Regulations 2002 include the following medical purposes: “diagnosis, prevention, monitoring, treatment or alleviation of disease,” amongst others.

However, the DMHT Guidance requires that to qualify as a medical device you must ask two questions:

1. Does the DMHT have a medical purpose?
2. Does the DMHT have sufficient functionality? 

Based on the technology’s characterisation, if the answer to both the above questions is yes, the DMHT will qualify as a medical device.

Does my DMHT have a medical purpose?

The MHRA states “DMHT are considered to have a medical purpose if they are intended as part of the broad process involved in the management of mental ill health.”  To determine if a DMHT has a medical purpose, the MHRA sets out a further two-step process. 

(1) Does the DMHT perform a clinical task that falls within the EU Medical Device Directive 93/42 (“EU MDD”) medical device definition?

The DMHT Guidance lists the EU MDD defined terms: diagnosis, monitoring, treatment or alleviation, compensation and prevention. It then sets out examples of clinical tasks that are likely to fall within these terms. For example, “diagnosis” includes “risks assesses,” “profiles,” “triages,” and “clinical decision support” (amongst others).

(2)  Does the DMHT target clinical conditions and symptoms?

The MHRA have taken the term “disease” from the EU MDD and provided a non-exhaustive list of targeted clinical conditions and symptoms in the mental health space that are likely to be covered by this term. Such as those DMHTs targeting conditions and associated symptoms according to established frameworks (e.g., WHO ICD-11) or those that reference or infer the full medical term for a disease (amongst others). Notably, it also includes DMHTs that target symptoms at levels considered at a well-being/sub-clinical level (e.g., low moods at a sub-clinical level) for individuals with another diagnosed medical condition (e.g., cancer). 

Does my DMHT have sufficient functionality to qualify as an SaMD?

The DMHT Guidance explains that DMHTs can be divided into functionalities. These could be an e-coach, triage, AI chatbot, fixed content psychoeducation, etc. Each functionality can then be divided into computational tasks.  The MHRA divides functionalities into either:

(1)  “low functionality”, which are unlikely to be SaMD; and 

(2)  “high functionality,” which are likely to be SaMD.

The MHRA states that to be considered a “low functionality” the DMHT must only perform one or more of the following computational tasks:

A.  Stores data/information without change;

B.  Communicates data/information without change or prioritisation;

C.  Processes user instructions to show fixed content in a similar manner to a user choosing a chapter in a digital book, audio book or video; and/or

D.  Processes data/information with an easily verifiable calculation/algorithm.

A-C appear to be equivalent to the functionalities excluded from the scope of medical devices in MEDDEV 2.1/6 and MDCG 2019-11. Namely: archival, communication and simple search, respectively. However, the exclusion of “easily verifiable” calculations/algorithms under D is only set out in previous UK Guidance (see Appendix 2 of the MHRA’s guidance on Medical device stand-alone software including apps). Importantly, the DMHT Guidance goes beyond previous MHRA Guidance and now sets out a list of six requirements that must be met in order to be considered “easily verifiable.”

If a DMHT performs a computational task outside of A – D it would be considered to have “high functionality.”  The DMHT Guidance provides the following examples:

E.  Processes user instruction with an interactive and/or personalised output;

F.  Processes data/information with a calculation algorithm that is not easily verifiable; and

G.  Processes data/information using AI.

The DMHT Guidance provides extensive worked examples of how these rules would apply to different functions.

In summary, the MHRA concludes:

• Medical purpose + low functionality = not SaMD
• Medical purpose + high functionality = SaMD

What Classification is my DMHT?

If a DMHT qualifies as a medical device it must be classified. The applicable rules will depend on which legislation is applicable as the classification rules vary between the UK’s Medical Devices Regulations 2002, the EU Medical Devices Directive 93/42/EEC and the EU Medical Devices Regulation (EU) 2017/745. The relevant law will apply depending on where the device will be placed on the market.

What are the key takeaways from this Guidance?

The DMHT Guidance runs to 51 pages and provides some of the most detailed worked examples of any guidance on SaMD. Despite the fact it only covers DMHT, it is highly likely the MHRA will follow the approach set out in this guidance for all SaMD. Therefore, anyone working in the UK’s SaMD and health/wellness tech space should take note and consider how this guidance may impact their products. 

The DMHT Guidance emphasises the importance of functionality in the qualification of DMHT. This appears to go beyond what was set out in previous MHRA and EU Guidance. Now the MHRA has set out a concept of “low functionality.” Products with “low functionality” will not qualify as a medical device, even if they have a medical purpose. 

Additionally, the MHRA has formalised its concept of what is an “easily verifiable” calculation/algorithm as a low functionality. This is not a concept that is set out in the EU’s MDCG guidance and so this may be a point over which the EU’s and UK’s approach diverge. Based on this rule, there might be scope for manufacturers to launch products as non-medical devices in the UK if they can fall under this exemption, before launch in the EU as a medical device.