Features
How femtech can navigate the EU medical device and AI rules
By Xisca Borrás, Partner – Life sciences regulatory and Ellie Handy, Senior Associate – Life sciences regulatory, Bristows
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” [emphasis added].
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 (e.,it is not an accessory nor driving/influencing the use of a hardware device) and does it not fall within Annex XVI[1]?
- 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.
- 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.
Elation Health has acquired Aster, a women’s health EHR startup created by sisters Fifi Kara and Dr Lailah Kara-Newton.
The deal, announced on 3 June 2026, will see Aster’s team join Elation Health as the company expands development of what it describes as the first agentic operating system for primary care.
An EHR, or electronic health record, is a digital system used by healthcare providers to store and manage patient information.
Aster was founded by Kara and Kara-Newton as an AI-native EHR platform for women’s health providers.
Elation Health said the acquisition would allow Aster to learn from its expertise in AI agents and support development of its agentic operating system for primary care.
Kyna Fong, co-founder and chief executive of Elation Health, said: “The Aster team impressed us with their vision and creative inventions to support independent practices.”
Fong said Elation, like Aster, was founded by siblings who wanted to change the healthcare system.
She added: “That shared north star means they understand what we’re building and why it matters. It was clear right away they would significantly add to our capabilities.”
Kara has spent 10 years creating consumer and business-to-business products across the UK, Europe and the US, and recently supported Meta’s Health & Fitness team, according to Aster’s website.
Kara-Newton previously worked as a hospital doctor in the NHS across medical and surgical specialties, including breast surgery, general surgery, emergency medicine and obstetrics and gynaecology.
Aster launched in 2023 after raising US$2.8m from Zeal Capital Partners, Cornerstone Ventures, Octopus Ventures and others.
Kara, Kara-Newton and Aster’s chief technology officer, Nacho Vazquez, will all join Elation.
Kara said: “From the moment we met Kyna Fong, Ashley Rogers, and the Elation leadership team, it was clear we were aligned on what matters most: that clinicians deserve truly incredible software that brings joy back to their practice. Together, we can now bring that vision to millions of primary care patients across the country.”
The sisters said their work was shaped by Kara-Newton’s first pregnancy, when undiagnosed pre-eclampsia led to an emergency caesarean section and neonatal intensive care admission for her son.
The founders said they wanted to build technology that could help prevent similar outcomes for other women.
The acquisition comes amid continued concern over maternal health inequalities in the US.
In the US, Black maternal mortality remains alarmingly high, with rates nearly double those of white women, and experts point to unequal access to care, implicit bias and fragmented approaches to care.
Article produced in association with Spital Clinic
Both the copper coil and the Mirena are more than 99 per cent effective as contraceptives — but they work in completely different ways, have opposite effects on periods, and suit very different people.
With the FSRH’s May 2024 licence extension for the Mirena now in effect, this guide covers the five key differences using up-to-date UK evidence, not the older guidance that many sources still repeat.
How Each Device Works
The FSRH March 2023 guideline set out the terminology now used across UK clinical practice: the copper intrauterine device (Cu-IUD) and the levonorgestrel intrauterine system (LNG-IUD).
The copper coil works by releasing copper ions that are toxic to sperm, preventing fertilisation. It contains no hormones at all, making it a strong option for women who cannot or do not want hormonal contraception.
The Mirena — the most widely prescribed 52mg LNG-IUD in the UK — thickens cervical mucus to block sperm, thins the uterine lining, and may suppress ovulation, though most users continue to ovulate normally.
According to Hull University Teaching Hospitals NHS Trust, the hormone levels it produces are lower than those from the combined contraceptive pill — relevant for women advised to avoid higher-dose hormonal methods.
The hormone-free nature of the Cu-IUD is its defining advantage for some; the localised hormonal action of the LNG-IUD is its defining advantage for others.
According to NHS guidance on the copper coil, neither device interacts with medicines or herbal remedies, and both can be fitted in women who have never been pregnant.
The way each device works also determines what it does to periods — often the deciding factor.
Effectiveness and Duration
The NHS confirms both devices prevent pregnancy in more than 99 per cent of users. When it comes to contraceptive effectiveness, there is no meaningful difference between them.
Where they differ significantly is duration. The copper coil lasts up to 10 years, and one fitted in a woman aged 40 or over can remain in place until menopause under FSRH March 2023 guidance.
For the Mirena, the picture changed in May 2024: the FSRH CEU statement on extended LNG-IUD use confirmed that all 52mg LNG-IUDs — including the Mirena, Levosert, and Benilexa — are now licensed for eight years of contraceptive use, up from five under previous guidance.
When the Mirena is used as part of HRT, it protects the uterine lining for up to five years before requiring replacement. Smaller-dose devices such as Kyleena (20mcg) are licensed for five years, and Jaydess for three.
Both are long-acting reversible contraceptives — fertility returns immediately after removal, with no delay or washout period. Both are available without a GP referral through the coil insertion and removal service at Spital Clinic.
What Each Device Does to Periods
The most important practical difference is what each device does to periods — and they go in opposite directions.
The copper coil typically makes periods heavier, longer, and more painful; the NHS notes this may ease after a few months, but heavier bleeding is one of the most common reasons for early removal.
Both devices can cause irregular spotting in the first three to six months after fitting.
The Mirena does the opposite.
According to Hull University Teaching Hospitals NHS Trust, it reduces monthly blood loss by 86 per cent at three months and by 97 per cent at twelve months.
Nine in ten women who use it for heavy periods see a significant reduction; around 20 per cent have no bleeding at all; and 80 per cent report meaningful pain relief.
NHS information on the hormonal coil confirms that periods often become lighter, shorter, and less painful — with many users finding they stop entirely after the initial settling-in period.
For women whose choice of contraception is being shaped by troublesome periods, those statistics make the direction of the decision clear.
For women with already disrupted cycles, it is worth booking a private specialist assessment before deciding — for this group, the choice of coil is as much a treatment decision as a contraceptive one.
Unlike the copper coil, the Mirena is licensed as a first-line treatment for menorrhagia — heavy or prolonged bleeding defined as losing more than 80ml per cycle or periods lasting longer than seven days.
In around half of cases, heavy periods have no identifiable structural cause, making the Mirena’s targeted local action particularly useful: it reduces bleeding at the endometrial level without surgery, general anaesthesia, or high-dose systemic hormones, and offers a non-surgical alternative to procedures such as endometrial ablation.
Side Effects, Risks, and Who Cannot Use Each Device
Both devices carry the same procedural risks. Pelvic infection affects around 1 in 100 women in the first three weeks; expulsion happens in roughly 1 in 20; and uterine perforation occurs in approximately 2 in 1,000 fittings — slightly higher in women breastfeeding within six months of delivery. Ectopic pregnancy, though rare, is a risk if either device fails.
The side-effect profiles diverge beyond those shared risks.
The copper coil carries no hormonal side effects — heavier periods are its main downside. The
Mirena may cause acne, headaches, mood changes, breast tenderness, and ovarian cysts; most resolve without treatment, but they are worth considering for anyone sensitive to progestogen.
The Mirena is also unaffected by vomiting, diarrhoea, or most drug interactions.
Each device has its own contraindications. Neither should be fitted in the presence of an active sexually transmitted infection or unexplained uterine bleeding.
The Mirena is not suitable for women with a history of breast cancer, certain liver conditions, serious cardiovascular disease, or certain uterine abnormalities.
The copper coil, meanwhile, can be used as emergency contraception if fitted within five days of unprotected sex — the only intrauterine option for post-coital protection.
The Fitting Procedure and What to Expect
The fitting procedure is the same for both devices: a 10 to 15 minute clinical appointment, ideally towards the end of a period, though it can happen at any point in the cycle.
The full appointment takes around 30 minutes. Local anaesthetic gel or spray is used to manage discomfort, and the NHS advises taking ibuprofen or paracetamol about an hour beforehand.
No surgery or general anaesthetic is needed. Some cramping and light spotting in the days after fitting is normal and usually settles within a week. Neither device requires you to have had children previously.
Fertility returns immediately after removal of either device — there is no waiting period before trying to conceive.
For most women, the choice between the copper coil and the Mirena comes down to one question: are hormones acceptable or not?
The copper coil suits women who want hormone-free contraception, those who cannot use progestogen, and those who need emergency post-coital protection.
The Mirena suits women who want lighter or absent periods, those managing menorrhagia, and those using it as the progestogen component of HRT.
Both offer equivalent contraceptive effectiveness and full reversibility.
The FSRH’s May 2024 extension of the Mirena’s licence to eight years makes it a stronger long-term option than many comparisons suggest — worth knowing if the information you have found is based on older guidance.
This article is produced for informational purposes only and does not constitute medical advice, diagnosis or treatment. Clinical guidance referenced reflects published NHS and FSRH standards as at March 2025. Individual circumstances vary; readers are advised to consult a qualified healthcare professional before acting on any information in this article.
This piece was produced in association with Spital Clinic, which provided background clinical information for editorial purposes. Hyperlinks to external sources are included for reference only and do not represent an endorsement of any product, service or organisation.
Article produced in association with Spital Clinic
Each year in England, approximately three million women take part in cervical screening.
While the majority receive a reassuring result, a proportion are referred for further investigation following an abnormal finding or a positive human papillomavirus (HPV) test.
For these women, the next step is a colposcopy.
Despite being a widely performed procedure, colposcopy remains poorly understood by many of the women referred for one, often because they receive limited information between the letter of referral and the appointment itself.
What Is a Colposcopy?
A colposcopy is a close examination of the cervix carried out by a specialist gynaecologist or colposcopist.
It uses an instrument called a colposcope, a magnifying device that remains outside the body and allows the clinician to view the surface of the cervix in detail.
Unlike a cervical smear, which takes a cell sample for laboratory analysis, a colposcopy is a direct, real-time visual assessment.
The procedure is explained in detail on the NHS colposcopy page, which covers what to expect before, during and after the appointment.
Colposcopy is most commonly recommended following an abnormal smear result, a positive HPV test, or unexplained symptoms such as irregular or post-coital bleeding.
It may also be used to monitor previously treated cervical cell changes.
Why Colposcopy Is Central to Cervical Cancer Prevention
Cervical cancer is the fourth most common cancer in women globally.
According to Cancer Research UK cervical cancer data, around 3,200 women are diagnosed with cervical cancer in the UK each year.
The vast majority of cases are linked to persistent infection with high-risk HPV strains.
Critically, cervical cancer develops slowly, typically over 10 to 15 years from normal tissue through progressive cell changes classified as cervical intraepithelial neoplasia (CIN) to invasive cancer.
Colposcopy allows clinicians to identify and classify these changes before cancer develops.
The grading system for CIN runs from CIN1 (mild cell changes, often resolving without treatment) through CIN2 (moderate) to CIN3 (severe, high risk of progression). Identifying the grade accurately determines whether monitoring or active treatment is recommended.
What Happens During a Colposcopy Appointment
The procedure typically takes between 15 and 20 minutes and is carried out as an outpatient appointment without general anaesthetic.
The patient lies on a couch with their feet in supports, in a position similar to a smear test. A speculum is gently inserted to allow the clinician to view the cervix.
A solution of diluted acetic acid is applied to the cervical surface, which temporarily turns any abnormal cells white, making them visible against the surrounding tissue. Iodine solution may also be used.
If abnormal areas are identified, the colposcopist may take a small tissue sample, called a biopsy, for laboratory analysis.
This is a brief procedure and may cause a momentary sensation of pressure or cramping. Biopsy results are usually available within two to three weeks.
NHS vs Private Colposcopy
NHS colposcopy services are available following GP referral or cervical screening notification. Waiting times, however, can vary significantly by region and current service demand.
For women seeking faster access, private colposcopy is available through specialist clinics. According to RCOG guidance on cervical screening and colposcopy, timely assessment and follow-up are important components of cervical health management.
Spital Clinic, based in Spital Square in the City of London, offers private colposcopy with appointments available on short notice, including morning, afternoon and evening slots throughout the week.
The clinic also offers cervical smear testing and gynaecological consultations, allowing women to manage their complete cervical health pathway in a single setting.
After the Colposcopy: Possible Outcomes
There are several possible outcomes following a colposcopy. If no abnormality is found, the patient is typically returned to routine cervical screening.
If low-grade changes are identified, monitoring with a follow-up appointment in 6 to 12 months is usually recommended. High-grade changes, classified as CIN2 or CIN3, usually lead to treatment.
Treatment for high-grade CIN is most commonly carried out using large loop excision of the transformation zone (LLETZ), a procedure performed under local anaesthetic as an outpatient.
LLETZ has a high success rate and most women return to their usual activities within a few days.
Who Should Consider a Private Colposcopy Referral
- Women who have received an abnormal cervical screening result or HPV-positive test and want prompt specialist assessment
- Those awaiting an NHS colposcopy appointment and experiencing significant anxiety about the delay
- Women with unexplained vaginal bleeding, persistent discharge or post-coital bleeding
- Those with a personal or family history of cervical disease who want regular specialist monitoring
A colposcopy referral is not a diagnosis. It is the next step in a well-established clinical pathway that has been responsible for reducing cervical cancer rates in the UK.
The earlier abnormal changes are identified, the more straightforward the management options.
Disclaimer: This article is produced for informational purposes only and does not constitute medical advice, diagnosis or treatment.
Clinical guidance referenced reflects published NHS, NICE and RCOG standards as at March 2026.
Individual circumstances vary; readers are advised to consult a qualified healthcare professional before acting on any information in this article.
This piece was produced in association with Spital Clinic, which provided background clinical information for editorial purposes.
Hyperlinks to external sources are included for reference only and do not represent an endorsement of any product, service or organisation.
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