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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.
Insight
WUKA and Royal Yachting Association partner to support women and girls in sailing
WUKA has announced a groundbreaking partnership with the Royal Yachting Association (RYA), including RYA Scotland and RYA Northern Ireland, supporting women and girls in sailing.
Building on WUKA’s growing #TackleAnything campaign – which has already reached thousands of girls across sports in the UK – this collaboration brings practical period solutions into sailing.
Together, WUKA and the RYA are committed to breaking down barriers so periods never limit confidence, participation, or performance on the water.
Ruby Raut, WUKA founder & CEO, said: “Partnering with the RYA has been incredibly important for us at WUKA.
“Sailing is an amazing way for women and girls to build confidence, and periods shouldn’t hold anyone back from enjoying the water or reaching their full potential.
“Through this partnership and our #TackleAnything campaign, we’re proud to provide practical solutions and innovative products that help female sailors feel comfortable, confident, and free to focus on learning, performing, and having fun.
“Breaking down barriers and supporting women to tackle anything — on land, at sea, and everywhere in between – has never felt more meaningful.”
WUKA, which stands for Wake-Up Kick Ass, shares the RYA’s commitment to inclusivity and empowerment.
In 2023, WUKA launched #TackleAnything, a campaign supporting women, girls and sportspeople with periods. Since its launch, the initiative has reached 3,576 girls across 46 clubs and partnered with a range of sports across the UK – from Scottish Gymnastics to Titans wheelchair basketball – helping young athletes play without limits and stay confident, comfortable, and in the game.
The brand offers period-friendly aquatic apparel and practical solutions that help women train and compete with freedom of movement and total assurance.
Through this partnership, WUKA will provide innovative period swimwear for young sailors across key RYA programmes, including the NI Sailing Team, the RYA Scotland Performance Pathway Programme, and the British Sailing Pathways Talent Academies.
By combining WUKA’s mission to challenge stigma with the RYA’s commitment to inclusion, the partnership ensures young sailors can focus on what matters most – learning, performing, and enjoying their time on the water – with confidence and comfort. RYA members will also receive a 10 per cent discount on WUKA products.
Sailing offers incredible benefits for women and girls, but time on the water can present unique challenges -particularly during menstruation.
Together, WUKA and the RYA are providing practical solutions that remove these barriers, helping young sailors participate fully and confidently in the sport.
Sara Sutcliffe, RYA CEO, said: “At the RYA, we have been making strides to break down barriers for women of all ages to help ensure they can experience the water in a supportive and positive environment.
“From education workshops and practical sessions, we want to make sure our female sailors are empowered and this partnership is another great example of how we can demonstrate possible tools to equip them to succeed”.
This partnership is part of the RYA’s wider commitment to making sailing a sport where women and girls can thrive. Alongside initiatives such as the Female Futures Group, the Women’s Race Officials Programme and all new Talent Academy Female Future’s Camps; it demonstrates a continued focus on removing barriers and creating meaningful opportunities across every stage of the sailing.
WUKA’s involvement ensures that practical solutions are available on the water, from innovative period swimwear to support resources, helping young sailors feel fully equipped and confident during training and competition.
By integrating these tools into RYA programmes, WUKA brings a new level of comfort and assurance to female athletes, allowing them to focus entirely on performance, enjoyment, and growth in the sport.
For any women and girls looking to learn more about sailing, visit www.rya.org.uk.
For more information on WUKA visit www.wuka.co.uk.
Insight
Study links changing population to low London screening rates
London’s shifting population is holding down breast screening uptake, experts have said, with the capital at 62.8 per cent in 2024, below the NHS’s acceptable 70 per cent threshold.
The London Assembly Health Committee recently heard that the capital faces distinct challenges compared with the rest of the country and that these issues must be addressed.
Josephine Ruwende, a cancer screening lead at NHS England, said frequent moves within the rented sector and the cost-of-living crisis pushing people out of London had made it difficult to reach eligible patients, which she described as “population churn”.
She said: “This is people changing addresses and then not updating their GP, this then affects the invitation process because GP details are used to identify individuals who are eligible.
“In boroughs where we have the highest population churn, we see it strongly associated with lower uptake.”
She noted that even in the wealthiest boroughs there can be high levels of movement, with around 40 per cent of residents changing address within a year.
Such areas also tend to have more people who own second homes or spend long periods abroad, making it harder for the NHS to keep contact details up to date.
As a result, screening invitations may be sent to out-of-date addresses or to people who are overseas.
Leeane Graham, advocacy lead at Black Women Rising, which supports women of colour with a cancer diagnosis, said there were cultural barriers, fear and a mistrust of the health service due to previous experience within communities.
She said: “If you’ve never been for a breast screening before, the thought of having a mammogram can be really, really terrifying.”
Helen Dickens, from Breast Cancer Now, said other reasons included a lack of understanding of breast screening, along with concerns about discomfort, trust and practical issues such as travel.
She said: “We have amazing public transport and we feel that we’ve got great accessibility, but we also know that we don’t have screening centres in every borough.
“We know that for some women that barrier of transport and access will still be a really big reason why they’re not attending screenings.”
NHS London launched its first screening campaign last year in response to the figures, aiming to increase detection at an earlier stage.
Features
The hidden cost of “business as usual” in gynecologic surgery
A Common Surgery with Outsized Consequences
Hysterectomy and myomectomy are among the most frequently performed surgeries worldwide.
Minimally invasive and robotic approaches have delivered clear benefits at the point of care, including shorter hospital stays, faster recovery, and fewer complications.
To remove the uterus or fibroids through small incisions, surgeons use a technique known as morcellation, in which tissue is cut into smaller pieces for extraction during surgery.
However, when tissue is cut without containment, those short-term gains can be offset by downstream harm.
The risks fall into three interconnected categories:
- dissemination of undiagnosed malignancy
- spread of benign tissue, including endometriosis and parasitic fibroids
- legal and financial exposure linked to off-label device use
Crucially, these costs often surface years after the original procedure and rarely where the original cost savings were realized.
Cancer Dissemination: A Known and Preventable Risk
The risk of occult uterine malignancy in women undergoing surgery for presumed benign fibroids is well documented.
The U.S. Food and Drug Administration has estimated this risk at approximately 1 in 350 women, prompting repeated safety communications recommending tissue containment during morcellation.
When morcellation is performed without containment, undiagnosed cancer will be dispersed throughout the abdominal cavity, effectively upstaging disease from localised to disseminated.
The clinical implications are profound, and so are the economic consequences.
Treatment costs for early-stage uterine cancer typically range from $40,000 to $60,000. Once disease becomes disseminated, costs can exceed $150,000 to $300,000, excluding indirect costs such as lost productivity, long-term disability, and caregiver burden.
Beyond treatment expenses, litigation related to morcellation-associated cancer spread has resulted in multi-million-dollar settlements, particularly during the power morcellation litigation wave of the mid-2010s. Several cases explicitly tied disease progression to tissue dissemination during surgery.
From a system perspective, a single preventable dissemination event can negate the cost savings of hundreds of minimally invasive procedures.
Benign Tissue Seeding: The Long Tail of Surgical Cost
Cancer is not the only concern.
Uncontained morcellation has also been associated with the spread of benign tissue, including parasitic fibroids and iatrogenic endometriosis, conditions that may present years after the index surgery.
Endometriosis alone represents one of the most expensive chronic gynecologic conditions. Multiple health economic studies estimate annual per-patient costs of $12,000 to $16,000, with lifetime costs exceeding $100,000, driven by repeat surgeries, chronic pain management, hormonal therapy, and fertility interventions.
While the financial impact may surface years later, downstream harm is increasingly traced back to the index procedure, including the choice between FDA-cleared containment and off-label alternatives used during tissue extraction.
Off-Label Use and the Quiet Accumulation of Liability
One of the least visible, but most consequential, dimensions of morcellation risk lies in off-label device use.
Many tissue bags currently used during morcellation are not FDA-cleared for prevention of tissue spillage during organ cutting and removal. While off-label use is common in medicine, it carries distinct legal and financial implications when complications occur.
Risk management guidance from MedPro Group, one of the largest medical malpractice insurers in the United States, has repeatedly warned that off-label use increases professional liability exposure in three key ways:
1. Burden of justification
When an FDA-cleared alternative exists, the legal burden shifts to the surgeon to prove that off-label use met the standard of care.
2. Informed consent vulnerability
Standard consent language may be insufficient for off-label device use, increasing exposure to failure-to-warn claims if complications arise.
3. Changed liability dynamics
Off-label use alters traditional liability dynamics, increasing scrutiny on clinical decision-making at the hospital and surgeon level.
Legal scholarship published in Clinical Orthopaedics and Related Research has echoed these concerns, noting that courts increasingly allow off-label status to be considered in malpractice cases, particularly when patient harm occurs and safer alternatives were available.
Recent U.S. court decisions have further reinforced that while off-label use is generally permitted, it is not immune from civil liability and, in rare but serious circumstances, criminal consequences when tied to demonstrable patient harm.
FDA Guidance Exists, Adoption Lags Behind
Regulatory expectations around morcellation are no longer ambiguous. The FDA has consistently called for tissue containment during tissue cutting to mitigate the risks of cancer and tissue dissemination.
Yet real-world adoption remains inconsistent.
A 2025 survey reported by News-Medical found widespread gaps in safe tissue containment during laparoscopic gynecologic surgery.
Respondents cited variability in training, institutional protocols, and access to FDA-cleared containment systems. Many surgeons reported reliance on improvised or non-cleared solutions despite growing awareness of regulatory and legal risk.
The result is a widening gap between guidance and practice, one that is increasingly visible to regulators, insurers, and hospital leadership.
Who Ultimately Pays?
The economic impact of uncontained morcellation does not fall on a single stakeholder.
- Hospitals face litigation exposure, rising malpractice premiums, re-operations, and reputational risk.
- Surgeons shoulder personal liability, heightened scrutiny around informed consent, and evolving standards of care.
- Payers absorb downstream oncology costs, chronic disease management, and repeat interventions.
- Patients bear the heaviest burden, including preventable morbidity, fertility loss, financial toxicity, and erosion of trust.
Taken together, these costs far exceed the price of prevention.
From Clinical Risk to Market Response
This growing recognition of risk has begun to reshape the market.
Before regulatory scrutiny intensified, power morcellation was widely adopted because it saved time, reduced operating room burden, and supported high procedural throughput.
It represented a multi-billion-dollar global market, supported by major surgical device manufacturers and deeply embedded in minimally invasive gynecologic practice.
The withdrawal of power morcellation from many hospitals did not eliminate the clinical need for efficient tissue extraction. Instead, it created a prolonged gap between surgical efficiency and acceptable risk.
That gap is now beginning to close.
With the emergence of FDA-cleared tissue containment systems designed specifically for morcellation, hospitals are reassessing whether power morcellation can be responsibly reintroduced in a manner aligned with regulatory guidance, patient safety, and liability mitigation.
This has significant implications for operating room efficiency, surgeon ergonomics, and system-wide cost management.
One example is Ark Surgical, a U.S.-focused surgical technology company advancing safety-first approaches to tissue extraction.
Its double-wall, airbag-like LapBox containment chamber was developed to support FDA-aligned morcellation while integrating into existing laparoscopic workflows, an increasingly important consideration as hospitals evaluate not just procedural efficiency, but long-term risk exposure.
Ark Surgical is currently in an active investment round, reflecting broader investor interest in technologies that address regulatory-driven risk while unlocking previously constrained markets.
More broadly, capital is flowing toward solutions that make it possible to restore clinical efficiency without reintroducing legacy risk.
The Cost Question Is No Longer “If,” but “When”
Healthcare systems already absorb the cost of uncontained morcellation through litigation, chronic disease management, repeat interventions, and loss of trust.
What has changed is visibility.
As clinical data, regulatory expectations, and market solutions converge, the question is no longer whether containment matters, but whether healthcare systems can afford to continue treating it as optional.
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