When is a women’s health app actually a medical device? 

There have never been more apps designed to support women with their health. 

Mental health apps. Period trackers. Fertility platforms. Menopause support. Pregnancy tools. Mood trackers. 

And honestly, we’re here for it. 

Technology has the potential to give women better access to information, help them understand their bodies and provide support in areas of healthcare that have historically been overlooked. 

But there’s an important regulatory question developers need to ask fairly early in the process: 

Is your app actually just an app? 

Because sometimes, it’s a medical device. 

When does an app become a medical device? 

Software can potentially fall within medical device regulations when it has a medical purpose, including where it is intended to diagnose, prevent, monitor, predict, prognose, treat or alleviate disease. 

This is commonly referred to as Software as a Medical Device (SaMD). 

And once your software enters medical device territory, things get considerably more interesting from a regulatory perspective. 

You may need to think about classification, risk management, clinical evaluation, quality management, technical documentation, post-market surveillance and the appropriate conformity assessment route. 

In other words, considerably more than downloading your app to the App Store and calling it a day. 

It comes down to intended purpose 

One of the biggest factors in determining whether software could be considered a medical device is its intended purpose. 

Essentially: what are you telling people it does? 

There is a significant regulatory difference between: 

“Track your mood.” 

And: 

“Detect signs of postnatal depression.” 

One is providing users with a way to record information. The other is potentially performing a medical function. 

Similarly, an app that records cycle dates is very different from software claiming to diagnose a reproductive health condition based on those dates. 

Those few extra words in your website copy, app description or advertising can potentially change the regulatory position of the product. 

Yes, marketing and regulatory really do need to speak to each other. 

Why does it matter? 

Mental health, fertility and menopause can be incredibly vulnerable areas for users. 

If someone downloads an app that claims it can identify signs of a condition, predict a medical outcome or help manage a diagnosed condition, they need to be able to trust the information it gives them. 

That’s why medical device regulation exists. 

For developers, getting the classification right early can also save an enormous amount of time, money and frustration. 

Discovering halfway through development, or worse, after launch, that your software should have been developed within a medical device regulatory framework is not a particularly fun surprise. 

And trying to fix everything retrospectively is rarely the easiest option. 

Building something in femtech or digital health? 

If you’re developing software for women’s health, don’t leave the regulatory conversation until the end. 

Work out your intended purpose. Understand what claims you want to make. Establish whether your software could fall within medical device regulations. Then build your regulatory strategy around that. 

Our medical devices team works with femtech, SaMD and digital health companies to answer exactly these questions. 

If you’re currently developing an app and thinking, “Hang on… does ours count?”, come and talk to us. 

We’d much rather answer that question now than help you untangle it later. 

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