To be or not to be a medical device?

The question may seem trivial: we all know what a medical device is... or don't we? The regulatory reality, however, is a little more subtle. The boundary between a simple healthcare product and a medical device can be as simple as a line in a marketing brochure, a feature activated in software, or a manufacturer's stated intention. In this article, we explore the concrete criteria that determine whether or not your product falls within the scope of the CE Medical Device (MD) mark. Spoiler: it's not up to you. At least, not on your own.

Definition: What exactly is a medical device?

A medical device (MD), according to Regulation (EU) 2017/745, is any instrument, apparatus, software, implant, reagent, material or other article intended by the manufacturer to be used, in humans, for specific medical purposes.These purposes include, in particular:

• The diagnosis, prevention, prediction, monitoring, treatment or alleviation of disease,
• The diagnosis, monitoring, treatment or alleviation of an injury or disability,
• The study or modification of anatomy or of a physiological or pathological process,
• Design control.
• All without the principal intended action being obtained by pharmacological, immunological or metabolic means - which distinguishes DM from drugs.

Simply put: what counts is the manufacturer's intention. And this intention isn't just in the manufacturer's head: it's expressed in black and white in documentation, communication media, instructions for use, and in fact.

Becoming a medical device: a strategic choice

As we said, it's the intended use that counts. Not the object itself. Let's take a simple example:

A scalpel is a medical device. But if that scalpel is sold for kitchen use, it becomes a common knife.
Conversely, a kitchen knife, if you start saying that it can be used in the operating theatre for surgical incisions... becomes a DM, with all that this implies.

This is where “intended use” comes in, as formulated by the manufacturer. This notion is at the heart of the regulations: it's what defines entry into the scope of Regulation (EU) 2017/745.

And this definition is not limited to a sentence on the label. It encompasses the entire discourse surrounding the product:

• What the instructions for use say;
• What the sales brochure shows;
• What the visuals on your website suggest;
• What your sales rep claims during a webinar;
• What the influencers you sponsor are doing.

Yes, marketing can turn a connected gadget into a medical device, sometimes without you even realizing it.

The trap of implicit medical functions

Things get tricky when the medical function is not explicitly claimed... but the intention is clearly understood. A classic example: an application that “helps you breathe easier in times of crisis” without ever mentioning the word asthma. The authorities will be able to read between the lines.

Another common case: wellness, fitness or concentration solutions. If your solution “helps prevent depressive relapses” or “supports epilepsy patients in their daily lives”... you're already very, very close to being a DM, if not right in the middle of it.

To be a DM or not to be a DM: a trade-off you have to weigh up carefully Why avoid being a medical device? Because it implies :

• CE marking by a notified body,
• Robust technical documentation,
• Risk management in compliance with ISO 14971,
• A quality management system compliant with ISO 13485,
• Rigorous post-market surveillance,
• And much greater legal liability.

But not being a DM also means being barred from certain uses, certain claims and certain markets. This can be a commercial brake, or a blurred positioning.

The choice must therefore be a strategic one: if your product is designed to really help patients, then you might as well take full responsibility for it, comply with regulations, and secure your market.

The false choice: when regulations catch up with you

In some cases, it's not a matter of choice, but of observation. If the authorities (such as the ANSM in France) consider that you have crossed the line, they may :

• order you to withdraw your product from the market,
• impose a compliance procedure,
• Or even penalize you.

European case law is clear: content takes precedence over declared intention. In other words, saying that your tool is “not medical” is not enough, if all your content says the opposite.

Software and medical devices: the boundary becomes blurred

Today, software is on the front line. A simple sleep tracking app, if it claims to detect apnea, falls within the scope of DM. Ditto for an AI that “suggests a diagnosis” or a platform that “guides treatment”.

The rules are precise (see MDCG 2019-11), and the European Commission is interpreting them firmly. The trend is clear: too much regulation is better than too little.

Conclusion: take an informed stand

It may be tempting to avoid CE marking in order to avoid the hassle of complying with regulations. But it's a risky gamble, especially if the discourse surrounding your product drifts towards the medical.

On the other hand, voluntarily entering the medical device arena also gives you the means to legitimize your positioning, gain access to healthcare markets, and build user confidence.

A medical device is not what you sell. It's what you say you sell.

So: to be or not to be a medical device? The answer lies in your documents, your slides, your web pages... and in the strategy you choose to adopt.