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Don’t get lost – How femtech can navigate the EU medical device and AI rules
By Xisca Borrás and Ellie Handy of the life sciences regulatory department at Bristows law firm
Femtech, short for female technology, is an important and fast growing sector. The EU is a key market for femtech, with five of the top 10 countries for femtech investment located in the EU.
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 for femtech products is whether they are regulated as medical devices or merely consumer products.
Additionally, many femtech products are embracing the use of artificial intelligence (“AI”). Therefore, another key question is whether products using AI will be regulated as “high-risk” AI systems under the EU’s new AI legal framework.
This article looks at when femtech apps and software qualify as medical devices in the EU and how the medical device and AI legal frameworks interact.
What is a software medical device?
The definition of “medical device” in the EU’s Medical Device Regulation 2017/745 (the “EU MDR”) includes software, used alone or in combination, that is intended by its legal manufacturer for a medical purpose. These medical purposes are listed in the EU MDR and include (amongst others):
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability; and
- control or support of conception.
The legal manufacturer is the person that puts their name/branding on the device, and takes responsibility for it.
Whether software is considered a medical device will depend on whether the manufacturer states it has a medical purpose in the relevant documentation/materials.
The EU MDR defines intended purpose as “the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation”.
What is the test for qualifying as a medical device in the EU?
There is 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:
- MDCG 2019-11 rev.1
Under the EU MDR, the Medical Device Coordination Group (“MDCG”) has published guidance on the qualification and classification of software as a medical device. It sets out five decision steps to help determine if a piece of software is a medical device in the EU. The steps are:
- Step 1: Is the product software?
- Step 2: Is it standalone software (i.e., it is not an accessory nor driving/influencing the use of a hardware device) and does it not fall within Annex XVI?
- 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. In this case, manufacturers will have to ensure they comply with the pre-market requirements set out in the EU MDR before they can place the software medical device on the market.
Notably, they will need to set up a qualify management system, compile a technical file, undergo the appropriate conformity assessment and affix a CE mark.
Importantly, the manufacturers would also need to consider post-market requirements, such as having a post-market surveillance system and undertaking post-market vigilance.
3. Other relevant guidance
The MDCG has also published a manual on borderline and classification of medical devices under the EU MDR.
Additional sources of guidance may also be available from national competent authorities. The legal manufacturer could also look at examples of other products already on the market to see how they are regulated (e.g. looking at EUDAMED). Although, we would caution anyone relying too heavily on the regulation of other products as there is no guarantee they are compliant.
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 EU MDR.
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 manufacturer recommends this piece of software for contraception and/or to support conception it will suddenly have a medical purpose and so, it would qualify as a medical device.
As such, the manufacturer would either have to bring the device into conformity with the EU MDR or take action to change the promotional materials to remove the medical claims.
Interaction between medical devices and AI legal frameworks
Under the EU MDR, devices are assigned risk classifications. For the lowest risk devices (Class I medical devices), the manufacturer can self-certify compliance with the EU MDR prior to the product being placed on the market or put into service in the EU.
However, high risk devices (Class IIa or above medical devices) must undergo a third party conformity assessment carried out by a notified body.
Notified body conformity assessments require a detailed review of the manufacturer’s quality management system, technical documentation, systems and procedures.
The process will often take more than a year to complete. Additionally, manufacturers have to grapple with ongoing burdens such as vigilance and post-market surveillance.
Under the EU MDR, most software as a medical device will be classified as a Class IIa or above.
Like the EU MDR, the EU’s Regulation (EU) 2024/1689 (the “AI Act”) also distinguishes between AI systems that pose different levels of risk.
The AI Act imposes onerous obligations on “high risk” AI systems, including in relation to accuracy, transparency, risk management, data quality and governance, and human oversight.
Although there is some overlap between the EU MDR and AI Act requirements, many are new AI-specific obligations. These pose a significant additional regulatory burden, increasing the complexity and cost of compliance for stakeholders.
Notably, the risk classification of an AI system that is itself, or is included in, a medical device is linked to the device’s classification under the EU MDR. Under the AI Act, AI systems are classified as “high risk” systems if:
(a) the AI system is a safety component of a medical device or the AI system itself is a medical device; and
(b) the medical device is required to undergo a third-party conformity assessment under the EU MDR.
Therefore, low risk medical devices (i.e., Class I medical devices) that are self-certified cannot be “high risk” AI systems.
Whereas, any device that requires a notified body to perform its conformity assessment will be a “high risk” AI system, and so will be subject to the additional AI Act requirements.
Unfortunately for those wishing to avoid the “high risk” AI system requirements, there are relatively few Class I devices under the EU MDR.
Therefore, the majority of medical devices that are an AI system or have an AI system as a safety component will qualify as a “high risk” AI system.
One notable example of a Class I device is software intended to support conception by calculating the user’s fertility status based on a validated statistical algorithm.
If this kind of software medical device is also an AI system, it would not be classed as a “high risk” AI system, so it would not be subject to the more onerous requirements in the AI Act.
However, the manufacturers of these devices would need to carefully consider any product developments that add additional functionality, as this can impact the risk classification of the product under both the EU MDR and AI Act.
For example, if the manufacturer added functionality to the Class I device so it could also be used as a means of contraception, it would become a Class IIb medical device and would need a third party conformity assessment.
In turn, as the software is also an AI system, this would mean the AI system would be considered “high-risk” and be subject to additional regulatory requirements under the AI Act.
Whilst AI has the potential to provide tremendous benefits for femtech, it also triggers additional complexity that can be time-consuming and costly to navigate.
It is important to get it right in terms of compliance in order to maintain consumer trust, avoid regulatory penalties, and pave the way for long-term success and viability.
By Xisca Borrás, Partner – Life sciences regulatory and Ellie Handy, Senior Associate – Life sciences regulatory at Bristows law firm.
SSRIs may help women with depression tolerate extreme heat, with responses more like those without depression, a laboratory study suggests.
Selective serotonin reuptake inhibitors, or SSRIs, are medicines commonly used to treat mental health conditions including depression and anxiety.
Media reports, social media posts and the US Centers for Disease Control and Prevention have suggested SSRIs may increase vulnerability to heat-related illness.
However, researchers found that women with clinical depression who took an SSRI may withstand extreme heat better than those not treating their depression with medication.
The study was carried out by researchers in the Penn State Department of Kinesiology.
Kathleen Fisher, first author of the study, said: “The human body primarily cools itself in two ways, by sweating and by increasing blood flow to the skin so that heat can be released to the environment.
“This study showed that depression interferes with how women’s bodies regulate their temperatures in the heat. Fortunately, SSRIs seem to largely restore the body’s ability to respond to increases in internal temperature.”
The team compared women without depression with those diagnosed with the condition, including women taking different types of antidepressants.
When their body temperatures rose, women with untreated depression were slower to begin sweating and increasing blood flow to the skin.
Their bodies were also less efficient at pumping blood to the skin than those of women without depression and women taking an SSRI.
Depression affects about 10 per cent of the US population and is twice as common among women, the researchers said.
SSRIs, including sertraline and fluoxetine, and serotonin and noradrenaline reuptake inhibitors, or SNRIs, including duloxetine and venlafaxine, are commonly prescribed alongside counselling to treat depression.
Previous research suggests depression disrupts the body’s ability to regulate temperature.
Penn State researchers had previously found that blood vessels dilated less effectively in women with depression. Dilation allows blood vessels to widen, helping more blood reach the skin to cool the body.
Women taking SSRIs showed improved blood vessel dilation similar to that seen among people without depression.
The latest study examined whether the same improvement occurred during heat stress.
Researchers recruited 64 women, almost all in their 20s. The group included 16 without depression and 16 with depression who were not taking medication.
A further 16 had depression and were taking an SSRI, while 16 had depression and were taking an SNRI.
Participants swallowed a small capsule that transmitted their internal body temperature throughout the experiment.
They then wore a suit fitted with tubes that allowed researchers to pump heated water through it.
After 10 minutes of adjusting to water at 91°F, around 33°C, the temperature was raised to 125°F, around 52°C.
The experiment ended when each participant’s internal temperature had risen by 1.8°F, or 1°C. This took an average of 45 minutes.
Researchers also measured skin temperature on the arm, calf, chest and thigh, along with heart rate, blood pressure, blood flow to the skin and sweating.
Professor W Larry Kenney, a study co-author, said: “The water pumped into the suit was 125 F, causing skin temperature to rise to about 100 F.
“As the skin continued to be heated to temperatures similar to sitting in a hot tub, the women’s internal temperature continued to rise.”
Women with untreated depression were slower to begin sweating and increasing blood flow to the skin than women without depression.
When blood flow to the skin increased, it was less efficient. Despite beginning to sweat later, women with untreated depression did not sweat less overall.
Women taking SSRIs responded to heat in a similar way to women without depression.
By contrast, women taking SNRIs responded similarly to those with untreated depression. SSRIs therefore normalised responses to heat stress, while SNRIs did not.
Researchers found no differences in blood pressure between the four groups.
Fisher said: “Up until now, there has been very little data on how depression or any of these classes of antidepressive drugs affect people’s responses to heat stress.
“This study took the first step toward understanding how women with depression, whether taking medications or not, may respond to extreme heat.”
Kenney said the findings challenged common beliefs that SSRIs increase vulnerability to heat.
He said: “In prior studies, my collaborators and I have identified how several factors, especially age, sex, and activity level, contribute to risk from extreme heat.
“Additionally, there has been widespread concern that many medications contribute to heat vulnerability, but the research evidence behind the risks of many medicines is often thin or nonexistent.
“Both physicians and people taking SSRIs should be aware that these medications do not seem to contribute to heat vulnerability. Rather, SSRIs improve heat tolerance in depression.”
Avni Wellness has secured Rs 4 crore, around US$470,000, in seed funding to expand its products and digital commerce capabilities.
The Mumbai-based women’s health start-up plans to strengthen its online retail operations and increase its presence across digital marketplaces.
It will also expand its cycle nutrition product range and grow its women-led network of micro-entrepreneurs.
Founded in 2021 by Sujata Pawar and Apurv Agarwal, Avni Wellness offers science-backed, toxin-free products spanning adolescence, reproductive years and menopause.
Its portfolio includes a patented antimicrobial reusable sanitary pad and a liposomal iron supplement designed to address iron deficiency among women in India.
Liposomal supplements encase nutrients in tiny fat-like particles intended to support absorption.
The company also offers products for polycystic ovary syndrome, or PCOS, calcium supplementation, urinary and vaginal health and seed-based hormonal nutrition. PCOS is a condition that can affect hormone levels, periods and fertility.
Proteus Partners led the funding round, with participation from angel investors Puru Gupta, Sreejith Moolayil, A. Velumani and Somya Nigam.
Avni Wellness said it aims to address gaps in women’s healthcare in India by focusing on hormonal health, nutrition and long-term wellbeing while incorporating livelihood generation and sustainability into its model.
Only 31 per cent of US voters believe healthcare does a good job of meeting women’s needs, according to a national survey.
The survey found broad agreement that women have distinct health needs requiring specific attention, but that care falls short at several stages of life.
Impact Research and Echelon Insights conducted the survey for Center Forward among 1,206 registered voters in the likely electorate across the US.
Tara Evans, marketing director for Plan B One-Step, said: “These findings should serve as a wake-up call for the health care industry and for policymakers.
“Women are telling us loudly and clearly that the system is not working for them. From reproductive health to menopause care to postpartum support, the gaps are real, they are significant, and voters want action.”
Only 31 per cent of respondents said the healthcare system did a good or very good job of meeting women’s health needs.
This compared with 41 per cent who said it performed well in meeting men’s health needs.
Half of the women surveyed said the system did not pay enough attention to their health issues.
Some 41 per cent rated the system as poor or very poor at meeting women’s needs immediately before, during and after menopause.
A further 38 per cent gave the same rating for care following pregnancy and during the postpartum period.
The figure was 35 per cent for care provided while women were seeking to prevent pregnancy.
Overall, 92 per cent agreed that women have distinct health needs deserving specific attention, including 89 per cent of Republicans and 95 per cent of Democrats.
Access to screening for cancers affecting women was considered very important for policymakers to address by 81 per cent of respondents.
Prenatal care was prioritised by 78 per cent, while 77 per cent highlighted both gynaecological care and cardiovascular services.
Postpartum care was considered very important by 72 per cent, while 68 per cent said the same about diabetes and weight management services.
Some 46 per cent of voters said the healthcare system did a poor or very poor job of meeting the needs of rural patients.
Rural women were six percentage points more likely than voters overall to report difficulty accessing quality care.
The findings also showed that gaps in care were not evenly distributed.
Women who described their health as fair or poor were 15 percentage points more likely than those in excellent or very good health to say the system paid too little attention to their needs.
People earning less than US$50,000 a year were among those most likely to feel overlooked.
Among voters earning between US$30,000 and US$49,000 annually, 61 per cent said the system did not pay enough attention to their health issues.
Evans said: “The picture this data paints is one of a system that works better for some Americans than others, and women, particularly those with lower incomes or in rural communities, are bearing the greatest burden of that failure.
“Plan B is committed to being part of the solution by ensuring that at the very minimum, women have access to emergency contraception when they need it.”
Plan B One-Step is an over-the-counter emergency contraceptive available in all 50 US states without identification or a prescription.
The company says it donates up to 500,000 units each year to clinics, non-profit organisations, advocacy groups and other qualifying organisations supporting medically underserved communities.
The survey was conducted from 12 to 16 January 2026 and had a margin of sampling error of plus or minus 3.2 percentage points.
Plan B One-Step is a backup form of birth control intended to help prevent pregnancy after unprotected sex or when another contraceptive method fails.
It is not an abortion pill and does not affect implantation or harm an existing pregnancy.
Emergency contraception such as Plan B is used within 72 hours of unprotected sex and works better the sooner it is taken.
The findings form part of the 2026 Women’s Health Mandate, a five-part bipartisan series examining women’s healthcare in the US.
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