Femtech World is continuing the search for a company to be crowned Startup of the Year.

The award is one of 10 to feature at the third annual Femtech World Awards.

The Startup of the Year Award celebrates an early-stage company making a bold impact in women’s health through innovation, vision and execution.

The winning startup will have demonstrated strong potential to transform care, accessibility, or awareness in women’s health with a scalable solution.

Consideration will be given to innovation, market traction, inclusivity, impact and the ability to address unmet needs.

The award is sponsored by Future Fertility.

The company is transforming fertility care with AI-powered solutions that close critical information gaps along the IVF journey.

Its clinically validated, non-invasive tools analyse oocyte images to predict each egg’s reproductive potential, supporting decision-making across key pathways: VIOLET™ for egg freezing, MAGENTA™ for IVF-ICSI, and ROSE™ for donor programmes and egg banks.

These reports deliver personalised insights into egg quality and ploidy potential, empowering patients and clinicians to make more informed decisions regarding next steps.

Today, Future Fertility’s technology is used in more than 300 clinics across 35+ countries.

Developed with the world’s largest oocyte image dataset linked to reproductive outcomes, Future Fertility’s AI models generate quality scores that not only guide treatment planning and manage expectations, but also serve as objective, actionable KPIs for labs—driving improved outcomes and transparency in fertility care worldwide.

The awards are free to enter, with winners receiving a trophy and an interview with Femtech World.

Find out more about the awards and enter for free here.

London-based women’s health platform SheMed has raised €43m to expand its UK operations and further develop its personalised healthcare platform.

The company, founded by sisters Olivia and Chloe Ferro in April 2024, will use the investment to scale its medical and technology teams, strengthen clinical infrastructure and enhance its data-driven systems.

SheMed offers weight management programmes using GLP-1 drugs — treatments that mimic a natural hormone regulating blood sugar and appetite — alongside wellness tracking and 24/7 support through its digital platform.

 Olivia Ferro, co-founder and chief executive of SheMed, said: “For more than a decade, I searched for answers to an undiagnosed health issu.

“As a GLP-1 patient myself, I know how transformative the right diagnosis and treatment can be.

“We built SheMed to give women the personalised support I struggled to find: care that listens, understands and empowers.”

The funding comes amid a broader wave of investment in UK and European health technology, particularly in preventative care and women’s health.

Other UK-based companies in similar areas have also raised significant sums this year, including Numan, which secured €51.6m to expand its digital healthcare platform into female health, and Hormona, which raised €7.8m for its AI-driven hormone health tracking solution.

Related UK ventures such as Perci Health and CoMind have also attracted new funding for personalised, data-led healthcare models.

According to analysis by EU-Startups, UK start-ups have raised about €14.7bn so far in 2025, signalling strong investor confidence in the country’s innovation sector.

The new investment will also fund SheMed’s research and patient-experience initiatives, aimed at improving access to personalised care for women across the UK.

Later this month, SheMed plans to publish results from what it describes as the first female-focused GLP-1 clinical study.

The findings are expected to reveal how GLP-1 medications affect women’s hormonal and metabolic responses, helping to refine future treatment approaches.

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:

1. 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.

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.