Diagnosis
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.
Women with endometriosis or painful periods were four to five times more likely to receive an STI diagnosis, a large Japanese study found.
Endometriosis occurs when tissue similar to the lining of the womb grows outside the womb. Although not strictly a menstrual disorder, it can cause pain, irregular periods and infertility.
The study was led by researchers at the University of Yamanashi and funded by Rohto Pharmaceutical Co.
The analysis examined health insurance claims from more than 3.4m women aged 40 or younger who had at least one healthcare visit during 2023.
Around 260,000 women, or 7.5 per cent of those included, had been diagnosed with endometriosis, dysmenorrhoea or both.
Dysmenorrhoea is the medical term for painful periods or menstrual cramps.
Women with endometriosis, dysmenorrhoea or both were four to five times more likely to have a recorded diagnosis of a sexually transmitted infection, or STI, than women without the conditions.
Diagnoses were significantly more common across every category examined, including chlamydia, gonorrhoea, trichomoniasis, genital herpes and other STIs.
Chlamydia was recorded in 3.5 per cent of women with menstruation-related conditions, compared with 0.7 per cent of those without them.
This represented a fivefold increase and the largest difference in prevalence between the two groups.
Gonorrhoea was diagnosed in 0.9 per cent of women with the conditions, compared with 0.2 per cent of those without them, also representing an increase of about five times.
Trichomoniasis, genital herpes and other STIs were diagnosed four to five times more often in women with endometriosis, dysmenorrhoea or both.
Women with endometriosis had the highest STI diagnosis rates overall.
Almost five per cent had a recorded chlamydia diagnosis, making it the most common STI in this group and more than seven times as prevalent as among women without menstruation-related conditions.
Women with dysmenorrhoea also had higher diagnosis rates for every STI included in the analysis.
The study found little evidence that hormonal treatments, including low-dose oestrogen-progestin therapy, affected STI diagnosis rates.
Differences between women who used hormonal treatment and those who did not were generally less than one percentage point.
Researchers suggested several possible explanations for the association between menstruation-related conditions and STI diagnoses.
One likely explanation is that women with endometriosis and dysmenorrhoea attend healthcare appointments more often.
As many STIs cause only mild symptoms, women seeking care more frequently for these conditions may be more likely to have infections detected.
Biological and behavioural factors may also play a part.
Menstruation-related conditions, particularly endometriosis, are associated with inflammation, pain during sex and sexual dysfunction, which could influence contraceptive practices and susceptibility to infection.
However, the authors said these possible explanations “remain speculative.”
They cautioned that differences in healthcare-seeking behaviour make it difficult to determine whether women with menstruation-related conditions acquire more infections or are simply more likely to receive a diagnosis.
The authors concluded that the findings underline the importance of STI screening and reproductive health education for women with endometriosis or painful periods.
WID-easy, the only non-invasive triage test for endometrial cancer in routine use in a European public health system, has been cited in Germany’s highest-tier clinical guidance; a marker that non-invasive detection is reaching clinical maturity.
The vaginal-swab test designed to spare women unnecessary invasive procedures has been referenced in the updated German S3 Guideline on Endometrial Cancer, its maker Sola Diagnostics has announced.
The Austria-based women’s-health diagnostics company behind the WID-easy Test, said the test now features in the recommendations-supporting background text of the guideline’s latest version (v4.0, May 2026; AWMF 032-034OL), in Section 4.3.
The S3 designation is the highest evidence- and consensus-based tier in the German clinical guideline system, broadly comparable in standing to NICE guidance in the UK, and is widely drawn on in clinical practice, reimbursement and liability assessments.
In Section 4.3, the guideline cites four peer-reviewed validation studies of the WID-easy Test and credits it with a sensitivity of more than 95 per cent and a negative predictive value of at least 99.7 per cent.
It describes a fall in invasive workup from 19 to two dilatation-and-curettage (D&C) procedures per cancer detected when compared with transvaginal ultrasound alone, assuming a realistic 3.4 per cent cancer prevalence in women with postmenopausal bleeding, and states that the test has the potential to improve the diagnostic workup of women with peri- and post-menopausal bleeding by cutting the rate of invasive procedures.
A growing burden, an imperfect standard
Endometrial cancer is the most common gynaecological cancer in high-income countries, and its incidence is rising, driven by ageing populations and increasing obesity, making it one of the fastest-growing cancer burdens in women’s health.
A number of groups are now developing non-invasive tests for earlier detection. The current standard, transvaginal ultrasound, is an imperfect triage tool: it misses serous carcinomas and performs especially poorly in black women, a group with disproportionately high endometrial-cancer mortality.
WID-easy has been validated prospectively across multiple cohorts, including a dedicated cohort of black women in Ghana (Ken-Amoah et al., 2025).
Adopted in routine care
WID-easy is the only endometrial-cancer triage test in Europe with real-world adoption in a public health system. It is UKCA-marked and in use across NHS pilot sites in England and Scotland, and is delivered through commercial laboratory partners across the DACH region of Austria, Germany and Switzerland. Its UK pivotal study, EASY-CARE, is funded by a competitively awarded NIHR i4i grant.
The postmenopausal bleeding pathway has been singled out for change across three UK Government strategy documents published in 2026 — the National Cancer Plan for England (DHSC), the renewed Women’s Health Strategy for England (DHSC) and the National HealthTech Access Programme (NICE).
The NICE initiative names speeding up access to better tools for detecting endometrial cancer in women with unexplained bleeding as one of only four priority areas.
WID-easy is the only non-invasive endometrial-cancer triage test that is UKCA-marked and commercially available for NHS use today, with no competing molecular test yet on the market.
“Seeing WID-easy referenced in a guideline of this standing confirms that the science behind non-invasive endometrial cancer detection has reached clinical maturity,” said Prof Martin Widschwendter, founder and member of the scientific advisory board at Sola Diagnostics.
“Our goal has always been to spare women unnecessary invasive procedures without missing the cancers that matter — and to do so equitably, across all populations.”
The WID-easy Test detects and triages endometrial cancer from a vaginal swab using DNA methylation. It is built on the WID-qEC biomarker, exclusively licensed from University College London Business and complemented by Sola’s own patent portfolio. The same methylation platform underpins a pipeline of further tests in cervical, ovarian and breast cancer.
A vaccine trial will test whether an mRNA jab can help stop precancerous cells developing into bowel and ovarian cancer in people with Lynch syndrome.
The first stage is due to launch this summer and will assess whether the jab can train the immune system to recognise and eliminate precancerous cells before cancer develops.
Around 175,000 people in England have Lynch syndrome, but only five per cent, or around 10,000 people, know they have it.
The inherited condition increases the risk of developing bowel cancer by 80 per cent and is linked to around 1,100 bowel cancer cases each year.
Lynch syndrome is also linked to a far higher risk of bowel, womb and ovarian cancer, alongside other types including stomach, pancreatic, kidney and skin cancer.
While the syndrome does not directly cause cancer, the genetic changes can lead to more abnormal cells developing, which then multiply and increase the risk of cancers such as bowel, prostate and endometrial cancer.
It is caused by an alteration in a mismatch repair gene. Carriers do not have any symptoms.
The new Intercept-Lynch trial is part of a scientific collaboration between the University of Oxford and Moderna, while Cancer Research UK has backed the vaccine’s development.
Once patients receive the new mRNA-4194 jab, experts will analyse their immune responses, assess the best dose and check whether the jab is safe.
The second phase of the study will include multiple centres across the UK, including Oxford, and is expected to begin in 2027.
The aim of the trial is to train the immune system with a vaccine to recognise abnormalities and stop them developing into cancer.
Professor David Church, Cancer Research UK senior cancer research fellow in the University of Oxford’s centre for human genetics and lead investigator of the trial, said: “People with Lynch syndrome are at risk of cancers over their entire lives.
“So, it’s very common, for instance, a woman to have a first cancer of her womb, and then some years later have a bowel cancer, or vice versa.
“The targets we’ve chosen for the vaccine were chosen based on their sharedness across multiple cancer types in Lynch syndrome, so we think they should provide broad protection, if the vaccine works.”
In people with Lynch syndrome, mutations can build up, making the cells containing them more likely to turn into cancerous cells.
However, those mutations can be made visible to the immune system and, with enough stimulation, the immune system can attack the abnormal cells and stop cancer from forming.
Professor Church said the mRNA jab acts as “an instruction manual” for the body to attack precancerous cells.
He added that, as with many vaccines, patients may need a booster jab at some stage.
On whether similar approaches could help prevent cancers not caused by Lynch syndrome, Professor Church said: “In terms of proof of principle that we can train the immune system to recognise these cancer-associated alterations and enhance the immune response against them to prevent these pre-cancers or prevent the progression of pre-cancer to cancer, that proof of principle should give us insights that are generalisable.”
David Berman, chief development officer at Moderna, said: “By applying mRNA technology earlier in the patient journey, we aim to harness the immune system when it can have the greatest impact.
“We are proud to bring this innovation to the UK, building on our long-standing collaboration with leading UK institutions to advance mRNA research and development.”
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