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The Wonderful World of Medical Devices – Part I: Definition and Claims

Here at MBM, we’ve been lucky enough to have partnered on the journeys of several medical device companies. According to Crunchbase, there are some 537 Medical Device companies in the UK that have completed a total of 758 fundings rounds, raising over $3.3 billion. But exactly what is considered a medical device?

A brief overview of the market (EU)

According to MedTech Europe, there are more than 500,000 medical technologies available in hospitals, community-care settings and at home and, in 2017, more than 13,000 patent applications were filed with the European Patent Office (EPO) in the field of medical technology – 7.9% of the total number of applications – more than any other sector in Europe.  40% of these patent applications were filed from European countries (EU28, Norway and Switzerland) and 60% from other countries, with the majority of applications filed from the US (37%).  There are almost 27,000 medical technology companies in Europe.  Most of them are based in Germany, followed by the UK, Italy, Switzerland, Spain and France. Small and medium-sized companies (SMEs) make up around 95% of the medical technology industry, the majority of these employing less than 50 people.  In all, the EU medical technology market was estimated to be roughly €115 billion in 2017.[i] 

Most of these technologies fall under the definition of a ‘medical device’.  Whether it’s a wound dressing, blood glucose monitor, replacement joint or a sophisticated app intended for use on a smartphone, these technologies share at least one thing in common: they are all regulated as medical devices in the EU.  A manufacturer or software developer looking to bring a new medical device to market in the EU is obligated to fulfil a long list of very specific and stringent requirements – the fulfilment of which, in most cases, will be assessed by a third party – before the product can legally display the CE Mark on its label and thus be placed on the market.  

But exactly what is considered a medical device? When you think of medical devices, what images come to mind?  A stethoscope?  A hospital bed?  A Covid-19 antibody test kit perhaps?  In fact, medical devices encompass an enormous range of range of products, software and technologies, from tongue depressors to MRI machines, as one of my previous bosses liked to say! 

So, is my product (or software) a medical device, or not?

When asked this question, my response usually is, “Does it have a medical purpose, or not?”  The Medical Device Regulation (MDR) very helpfully contains a definition of ‘medical device’:

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 following products shall also be deemed to be medical devices:

  • devices for the control or support of conception;
  • products specifically intended for the cleaning, disinfection or sterilisation of devices ...[ii]

This definition is quite a lot to take on board but, in most cases, it’s sufficient in determining whether or not the product in question is  a medical device.  (In “borderline” cases where after reading through the above definition it’s still not clear if the product is a medical device, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and their counterparts in other EU Member States are always prepared to consider unique situations and offer their opinion.)  Bear in mind that this definition includes ‘software’, including both software incorporated into a physical device and stand-alone software that fulfils a medical purpose, the latter known as ‘software as a medical device’ (SaMD).

It’s all about the claims

Although medical devices are regulated in a significantly different way compared to medicines and biologics, there is some commonality across all types of healthcare products in that they are all ultimately regulated based on the marketing and clinical claims made by their developers.  Earlier, when I ask about a product’s medical purpose, I am really asking, ‘What does it do and how does it do it?’  If, for example, you want to claim that your product will ‘increase the patient’s mobility’ by making a small modification to the anatomy (a medical purpose) and it meets the definition of a medical device in terms of how it achieves this claim, then we know we have a medical device.  What we need to do now is prove the claim(s).  But this particular example raises questions.  Which specific part(s) of the body will be more mobile?  By how much and by what measure? 

Similar questions arise about how software achieves its intended purpose, and how these claims are supported (hint: in all cases medical device software must be formally validated).

As such, it’s important to be clear, from the earliest stage in a product’s design and development, what you want to claim, and, equally, what you think you’ll be able to prove (before you run out of money!).   

The requirements set out in the MDR are focused on establishing both safety and efficacy – which of course have a direct correlation to your claims.  It is often advisable, therefore, to consider entering the market with reduced or narrowed claims that are easier to demonstrate via testing, and then gradually – through knowledge and experience gained from your own device, similar devices and further testing – broaden your claims which should allow you to increase your market.

Classifying your device

Once you’ve determined your product is a medical device based on its intended use and the claims you intend to make for it, the next step is to determine what ‘class’ the device falls into, which determines its route to conformity under the MDR, and thus its route to CE marking and market entry.  Under the MDR, medical devices fall into one of four risk-based classes: I, IIa, IIb or III, where Class I is lowest risk.  Everything we do in the medical device industry is risk based.  If we’re not constantly evaluating our product’s actual – or potential – risk to patients, users and, in some cases, the environment, then we’re not doing our job correctly.  Annex VIII of the MDR (one of 17 Annexes) sets out the classification rules – which, not surprisingly, are risk based in that they divide up medical devices into types, based on their intended uses and corresponding risk profile.  Think of Annex VIII as a sort of decision tree used to help the manufacturer/developer to identify the most appropriate risk classification for your device.  Some of the basic considerations used when applying the rules are whether the device comes into contact with the patient, and if so, for how long?  Is it invasive?  If so, is it surgically invasive?  If it doesn’t come into contact with the patient, does it hold or channel blood or other substances that will eventually be administered to the patient?  And so on.  If the device is ‘active’, i.e. it relies on an external source of power to function, there is a set of special rules that need to be considered (SaMD is always considered to be ‘active’).  It’s worth noting here that where two or more rules apply, each with a different classification, the higher risk classification applies.

By the way, the above is relevant to the MDR.  The approach under the IVD Regulation is similar, but the risk classification criteria and rules are set out somewhat differently.  There are too many IVD specific details to include here and it is perhaps better to review the IVD Regulation in a separate blog post.

The medical device industry is a wonderful place to work and I hope the above provides some insight into my world.  It is full of bright people focused on trying to help sick people get (or stay) healthy.  What could be more rewarding?

In my next blog, I’ll discuss the route to conformity and getting your device to market.

[i] www.medtecheurope.org

[ii] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices

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