Mindset XR Module 2: What is a medical device?

UK Medical Device Regulations (MDR) 2002 is the current regulation in the UK and defines medical devices as:

‘medical device’ means an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which is intended by the manufacturer to be used for human beings for the purpose of:

— diagnosis, prevention, monitoring, treatment or alleviation of disease,

— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

— investigation, replacement or modification of the anatomy or of a physiological process, or

— control of conception; and

does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means,

and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device;

EU MDR 2017 is the current regulation in the EU and defines medical devices as:

‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,

— providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

The original EU Medical Device Directives were written in the early 1990s. Since then, there have been significant developments in technology, particularly in relation to software. Unlike the UK definition, the EU MDR definition has specific details about software and clarifies other medical purposes that are considered medical device actions, such as prognosis and prediction of disease.

This simple flow chart can help you to understand whether your product is a medical device:

Step 1: Annex XVI refers to a very specific list of product groups which do not have an intended medical purpose but are still medical devices, for example contact lenses and certain equipment or substances used in cosmetic surgery. 

Step 2: This question refers to the features of the software and the amount of processing being done by the software. For example, a software simply displaying guidelines to a clinician would unlikely be considered a medical device. Any actions beyond this could be considered medical device functions. 

Step 3: The final question refers to the intended population and who the action is being performed for. Softwares intended only to aggregate population data would not be a medical device whereas software considered to be for the benefit of individual patients could be. Again, there are some nuances here but this is a good starting point to starting thinking about where your product might fall in terms of medical device status. 

There are some key points to consider when developing medical devices, particularly if your device is relatively borderline. You must have evidence to support any medical claims you make, as the MHRA can ask to see this and can even force you to take your device off the market if you are not able to demonstrate the evidence required.  

You must have evidence to support any medical claims you make, as the MHRA can ask to see this and can even force you to take your device off the market if you are not able to demonstrate the evidence required. 

There are some key points to consider when developing medical devices, particularly if your device is relatively borderline, including:

• Quotes or testimonials repeated in product literature or your website.
• Any medical claims you make, including adverts, app store description and category, your website and social media channels.
• If a consumer would view your product as a medical device: depending on the mode of action and manner of use as perceived by the consumer, or if it is possible for an objective observer, such as the MHRA or an averagely informed consumer to view a product as a medical device, the device could be considered a medical device.
• Adding general disclaimers (for example ‘this product is not a medical device’) are not acceptable if medical claims are made or implied elsewhere in the product labelling or associated promotional literature etc. 

It’s important to note that not all software is a medical device, including:

• Actions such as “simple search”: this refers to the retrieval of records by matching record metadata against record search criteria or to the retrieval of information. This does not qualify as medical device software (eg library functions).
• • Software intended for non-medical purposes: this includes invoicing or staff planning. This does not qualify as a medical device software and does not fall under the Medical Devices Regulations.

  This highlights the importance of crafting a clear intended use as it will support you in determining the medical device status of your product, and communicating this to others.