To Be Or Not To Be … A Medical Device – Is your Femtech software regulated as a medical device in the UK?

Femtech, short for female technology, is an important and fast growing sector. The UK is a key market for femtech as it is ranked second for investments (just behind the US).¹ Femtech products are developed for many areas of women’s health, such as menstrual health, pregnancy planning and monitoring, menopause and mental wellbeing. As femtech is intrinsically linked to health needs, a key question is whether a femtech product is regulated as a medical device or merely a consumer product. This article looks at when femtech apps and software qualify as medical devices in the UK.

What is a software medical device?

The definition of “medical device” in the UK’s Medical Devices Regulations 2002 (the “UK MDRs”) includes software, used alone or in combination, that are intended by its legal manufacturer for a medical purpose. These medical purposes are listed in the UK MDRs and include (amongst others):

• diagnosis, prevention, monitoring, treatment or alleviation of disease;
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; and
• control of conception.

The legal manufacturer is the person that puts their name/branding on the device, and takes responsibility for it. The UK MDRs define intended purpose as “the use to which the device is intended according to the data supplied by the manufacturer on the labelling, the instructions for use and/or the promotional materials” (emphasis added). Therefore, whether software is considered a medical device will depend on whether the manufacturer states it has a medical purpose in the relevant documentation/materials.

What is the test for qualifying as a medical device in the UK?

There are a selection of guidance documents that can assist you in determining whether a product should qualify as a medical device. We summarise some of the key guidance below: 

1. MEDDEV 2.1/6² 

The European Commission sets out five decision steps to help determine if something is a software medical device that are relevant in the UK. The steps are:

• Step 1: Is the product software?
• Step 2: Is it standalone software (i.e., it is not incorporated into another medical device)?
• Step 3: Is it performing an action on data beyond storage, archival, communication, simple search or lossless compression?
• Step 4: Does it act for the benefit of an individual patient?
• Step 5: Does it have a medical purpose (as set out in the medical device definition)?

If the answer to all five questions is yes, it will qualify as a medical device.

2. DMHT Guidance

In February 2025 the MHRA published guidance on “Digital mental health technology: qualification and classification” (the DMHT Guidance). It focuses on digital mental health technologies³ (“DMHTs”). However, we expect the MHRA to apply the approach it set out in this guidance to all medical devices.

The DMHT Guidance states there are two main questions to determine if a DMHT (and arguably software more broadly) is a medical device:

1. Does the DMHT have a medical purpose; and
2. Does it have “sufficient functionality”?

The first question aligns with Step 5 of the MEDDEV 2.1/6 decision steps. According to the DMHT Guidance, to determine the medical purpose you should ask (i) does the DMHT perform a clinical task (as per the medical purposes listed in the definition of a medical device); and (ii) does it target clinical conditions or symptoms.

The second question is similar to Step 3 of the MEDDEV 2.1/6 decision steps, but it goes further. The MHRA states that DMHT can be categorised into functions/computational tasks that are either (1) high functionality; or (2) low functionality. Low functionality is limited to computational tasks that (A) store data/ information without change; (B) communicate data/information without change or prioritisation; (C) process user instructions to show fixed content; or (D) process data/information with an easily verifiable calculation/algorithm (there are further steps to determine is something is “easily verifiable”).⁴ The DMHT Guidance provides a lot of worked examples of what kinds of functionality would be considered “high” or “low.”

Software that has low functionality, even if it has a medical purpose, will not qualify as a medical device. Therefore, those developing femtech should carefully consider what their product actually does. It may be possible to argue software is not a medical device, despite having a medical purpose, if the functionality is sufficiently simple.

3. MHRA Guidance on Medical device stand-alone software including apps (including IVDMDs) (the “MHRA Guidance”)

The MHRA Guidance sets out a series of flowcharts and worked examples to help determine whether software would be a medical device or not. The guidance details types of purposes that are not considered a medical purpose. These include software that provides patient medical education, monitors fitness/health/wellbeing and/or stores medical information without change. The MHRA also provides a number of worked examples on when products would or would not qualify as medical devices (e.g., for products involved in the control of conception). Developers of femtech products can look at these examples to guide them in deciding if their product would likely be a medical device.

4. Other Relevant Guidance

The MHRA has published other useful guidance documents. For example, it has provided specific guidance for crafting an intended purpose of software medical devices. It has also published guidance on the borderlines between medical devices and other products.

What if you’re not a medical device?

If the software does not qualify as a medical device, the product will not have to comply with the UK MDRs. However, the manufacturer should be careful about how it promotes its product and the claims it makes about it because, as discussed above, a medical device is defined based on the manufacturer’s intended purpose.

Let’s take the example of a mere period app. Using it for logging period dates, tracking ovulation, and predicting future cycles has no medical purpose and is therefore not a medical device. However, if its developer/manufacturer recommends this piece of software can be used for the control of conception, it will suddenly have a medical purpose and, as such, it would qualify as a medical device. In that case, the manufacturer would either have to bring the device into conformity with the UK MDRs or take action to change the promotional materials to remove the medical claims.

The “B-word” – Brexit and the EU

After the UK left the EU, the EU implemented new medical device and in vitro diagnostic medical device regulations.⁵ These regulations brought about a number of changes to the regulatory framework, and so the regulatory frameworks for the EU and UK no longer fully align. Notably, most software medical devices are a high risk classification under the EU regulatory framework and so require a third party to conduct their conformity assessments.⁶ Whereas in the UK, most software medical devices are Class I and can be self-certified by the manufacturer.

The UK will continue to allow medical devices that are CE marked under the EU regulations until at least 2030 (and the Government has also indicated it intends to recognise CE marks beyond this date). However, the EU does not recognise medical devices with a UKCA mark under the UK MDRs. Therefore, if a femtech company wants to launch its product in the EU as well as the UK, the manufacturer should consider whether it makes more sense to comply with the EU framework and gain access to both markets. Or whether to launch in the UK first as a Class I device, until it is able to undergo a third party conformity assessment it requires for the launch in the EU.

Footnotes

• [1] https://dealroom.co/guides/femtech
• [2] https://ec.europa.eu/docsroom/documents/17921
• [3] DMHTs are “digital and software products designed to support mental health and wellbeing” (emphasis added). These could include websites, internet-based platforms and apps used in general “non-medical” technologies (e.g., in computers and fitness wearables) or in medical devices.
• [4] We have previously discussed the DMHT Guidance in more detail - https://inquisitiveminds.bristows.com/post/102jzqs/a-wellcome-development-for-samd-the-uk-publishes-guidance-on-digital-mental-hea
• [5] EU rules applicable to medical devices apply to Northern Ireland, so products placed on the market in this region should follow EU rules rather than UK rules.
• [6] Notably, devices to support conception are still Class I devices under the EU Medical Device Regulation (EU) 2017/745.