As with everything in medical devices, it is not always straight forward, we often have to answer ‘it depends’.

Technology seems to move forward at a blistering pace, coupled with the types and diversity of devices available, it is not surprising that questions arise from manufacturers trying to apply the ‘catch all’ regulatory requirements.

Software is a great example of rapidly evolving technology that has often evolved so fast that we are often left scratching our heads as to how it can be effectively regulated. Considering Europe for example, the old European Medical Device Directive (MDD) was amended in 2007 under Directive 2007/47/EC to include software. This resulted in the addition of software in the definition of a medical device, an update to Essential Requirement 12 (to include software validation) and confirmation that stand alone software is to be considered an active device.

Unfortunately, the MDD still fell short with respect to software, it is only mentioned 7 times, so clearly with all the advances with software apps and artificial intelligence, it was clear that the MDD was not an ideal instrument to deal with this rapidly evolving area of MedTech.

Still, the question of ‘is my software a medical device’ could be answered by the MDD. The reason being that the definition of a medical device was set and if your software met the definition, based on its intended purpose, then it would be considered a device. The problem is (and often why the answer is ‘it depends’) is that the definition is just vague enough to allow some confusion.

As everyone reading this will know, the MDD is no longer really with us (albeit hanging in there still for legacy products) we have a ‘new’ regulation to work with. We say ‘new’ because it will be 6 years old this year, so not exactly ‘brand new’. Since the EU Medical Device Regulation (MDR) has been published, there has been an explosion of Artificial Intelligence, it seems that every day there is something about ChatGPT, or AI in the mainstream news. So how does the EU MDR help manufacturers in the software space? Let’s take a look.

Just for comparisons sake, the EU MDR mentions software 53 times. On the surface, it appears that this is a giant leap forward in the regulation of software, after all, it is spoken about over 7 times more than in the MDD, so surely that must answer all of our questions right? Unfortunately not. Whilst the MDR is better at considering software as a mainstream type of device (it is no longer just tacked on to a definition) we do need to understand exactly what the MDR brings in terms of clarity for software as a medical device manufacturers.

One of the ‘best bits’ that is quite helpful, is not actually part of the articles and annexes of the regulation. It can be found in the introduction, specially point 19:

“It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a medical device, while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not a medical device. The qualification of software, either as a device or an accessory, is independent of the software's location or the type of interconnection between the software and a device.”

This statement shows us that there is a clear define between life-style apps and medical devices.

BUT.

The medical device definition, which is key to all of this is unfortunately still a little vague. Software is in there, but it is still open to some interpretation as to whether it definitively falls into being a medical device.

If you can’t recall it off by heart, here is the definition of a medical device from the EU MDR:

“‘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 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 as referred to in Article 1(4) and of those referred to in the first paragraph of this point.”

So, does a menstrual cycle tracker app on your phone meet the definition of a medical device, or is it a well-being app?

If the intended purpose of the app is to tell you when the best time to conceive is, it could be considered as ‘supporting conception’ and may be a medical device. If it is just used as a diary function, then it is very unlikely it would be considered a medical device. You will note the ambiguity in firmly choosing one side or the other. That is because we do not know enough about the software and its intended purpose. We would need to study the provided instructions of this app and review the full functionality of the app to make a definitive decision. This is where a lot of the difficulty comes in, defining the full and correct intended purpose to an extent that allows you to be definitive.

The rest of the EU MDR software mentions do not really help us to answer this question, they merely provide requirements for software that does meet the definition.

So we can see that there are still some difficulties in answering the question ‘is my software a medical device?’.

This is something that is well known and thankfully we have the European Commission and the Medical Device Coordination Group (MDCG) who have provided us with some much needed guidance on this topic.

Firstly the European Commission have published an infographic titled ‘is your software a medical device?’ Unfortunately this infographic still requires us to know whether we definitively meet the definition of a medical device based on the intended purpose. But it is nice to have a logical thought process to follow.

Secondly, the MDCG issued MDCG 2019-11, titled Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR.

In addition to providing an excellent process to follow, the guidance provides examples of software that may or may not be considered medical devices. The guidance covers open questions that you need to fully understand, such as representation of data. Are you representing the data in a specific way for cosmetic purposes, or are you representing data in such a way to support a decision? This is why manufacturers often need a fresh pair of eyes, or experts to ask these questions, thereby really understanding what the software is actually doing and whether it can be qualified as a medical device.

There are of course other complexities to consider with software, such as it being an accessory to a medical device, or driving/influencing the use of a medical device, so it may not meet the definition of a medical device taken in isolation, but as soon as it is used in combination with a medical device, by default, it can become a medical device.

It may seem a simple question ‘is my software a medical device?’ But there is a lot that needs to be considered before a definitive answer can be given. That is why the first answer is ‘it depends’.

Join us on our next SaMD training to learn more about how software is developed and regulated as a medical device.