News
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.
By Con Raso, managing director, Tuned Global
Music and movement are neurologically intertwined. Tempo influences pace, rhythm supports endurance, and familiar tracks can reduce perceived exertion.
Beyond physiology, music creates shared moments. It sets the atmosphere, builds anticipation and turns individual activity into collective experience.
For sports, wellness and fitness brands, this means music selection needs to align with brand values, customer experiences and emotional outcomes.
Well-chosen music increases workout intensity and duration, improves customer retention, strengthens brand recognition, creates community and cultural relevance, and opens new partnership models.
When delivered through properly licensed, data-informed systems, these outcomes become measurable and scalable.
Music also gives brands a way to stay culturally connected to their audience. The question for operators is how to use music strategically and legally.
This is especially important because the way brands approach music has changed significantly.
Early adoption in wellness, fitness and leisure centres often meant plugging in a Spotify playlist and hoping for the best.
Today’s leading sports and fitness innovators are far more sophisticated, curating music experiences that are brand-led, data-informed, tailored to specific audiences and workouts and fully licensed for commercial use.
This shift is being powered by specialist music technology platforms like Tuned Global, which works behind the scenes with brands to manage licensing, catalogue access, analytics and distribution at scale.
Rather than forcing sports brands to become music experts, these platforms allow them to offer legally compliant music in commercial environments, control curation across locations or content formats, and adapt music to different activities and intensities.
Through advanced APIs and centralised cloud infrastructure, operators can manage licensing, catalogue access and music governance at scale, while maintaining full creative control.
They also provide the reporting required by rights holders and integrate music into apps, devices, wearables and connected platforms. The result is music that feels intentional, on-brand and deeply embedded in the experience.
Music in action
Lululemon Studio and Mirror: At-home Fitness and Health
When Lululemon acquired Mirror, it marked a shift towards fully connected, at-home fitness where content, coaching and atmosphere converge.
Music plays a key role in making those workouts feel immersive and motivating, especially without a physical studio or shared space.
Instructors needed access to curated, commercially licensed music delivered consistently across live and on-demand workouts, while remaining compliant with music rights regulations.
Tuned Global provided Lululemon Studio with a branded playlisting app solution that enabled instructors to curate fully licensed music tailored to each workout.
Drawing from a licensed commercial catalogue and supported by usage reporting to rights holders, the system ensured compliance while giving instructors the flexibility to design high-energy, brand-aligned sessions.
The result was a seamless blend of movement, coaching and sound that makes digital workouts feel immersive and premium.
Psycle London: Performance Led Experiences
Con Raso
Boutique fitness studio Psycle London has built a loyal following by transforming workouts into performance-led experiences where music is central to the brand.
Each class is choreographed to sound, with instructors designing sessions that build emotional peaks and sustained intensity.
As Psycle expanded its digital and on-demand offering, it needed a way to give more than 70 instructors access to fully licensed commercial music while protecting the business from legal and reputational risk.
Tuned Global delivered a branded playlisting app that enabled Psycle’s instructors to search a cleared commercial catalogue by artist, genre or BPM, preview full tracks and build tailored playlists for classes ranging from high-intensity rides to strength and conditioning.
Behind the scenes, the music is delivered through secure API infrastructure integrated into Psycle’s own platform, with automated reporting to rights holders and support across label and publishing negotiations.
By combining creative flexibility with licensing governance, Psycle were able to scale its music-led experience across studio and digital environments without compromising on brand integrity, compliance or operational control.
Steezy: Movement and Music
Steezy, one of the world’s leading online dance platforms, sits at the intersection of sport, movement and music.
For dancers, music is not background sound. It defines timing, style and expression.
As Steezy scaled internationally, music became both its greatest asset and its biggest operational challenge. Delivering classes built around commercial tracks created both operational complexity and significant licensing risk.
Tuned Global provided the licensed music catalogue delivery infrastructure that enabled Steezy instructors to search a cleared catalogue, curate playlists tailored to specific classes, and prepare sessions using full commercial tracks.
The system ensured that music used across Steezy’s app and desktop platform was properly licensed and reported to rights holders, supporting global expansion without exposing the business or its creators to legal liability.
By combining instructor-friendly tooling with robust licensing governance, Steezy was able to continue growing its international dance community while keeping music at the centre of the experience.
A wider wellness ecosystem
For wellness, sports, fitness and leisure operators considering deeper music integration, a few principles stand out.
First, treat music as a product feature. It should support the outcome you want, whether that is higher intensity, calm recovery, emotional connection or brand recognition.
Second, get licensing right from day one. Using consumer streaming services in commercial environments exposes brands to legal and reputational risk.
For example, In 2019, more than 20 music publishing groups filed a $150 million copyright lawsuit against Peloton, alleging the company used more than 1000 unlicensed songs in its workout videos.
In another example, just last year the Federal Circuit and Family Court of Australia ordered a Sydney gym chain owner and five of his companies to pay more than $235,000 in damages and interest after operating multiple locations without a valid OneMusic licence.
Third, give creators freedom while maintaining brand control. Instructors, coaches and athletes bring personality, so give them tools to curate music safely within brand guidelines.
Last but not least, use data to refine the experience.
Track how music impacts engagement, completion rates and retention, because music is measurable. Finally, think cross-platform.
Your music strategy should work across physical venues, mobile apps, connected devices and on-demand content. Consistency builds trust.
What’s ahead for music as a performance tool
Music in wellness will become even more adaptive. As AI, biofeedback and real-time analytics become more embedded in fitness technology, music will increasingly respond dynamically to heart rate, pace or emotional state.
Early implementations in health and performance environments are already demonstrating how adaptive music can optimise outcomes.
As wearable technology and connected fitness continue to evolve, music will play an increasingly central role in shaping personalised experiences.
The infrastructure choices operators make now will determine how easily they can adopt these capabilities later. Those who invest early in licensed, data-informed music systems will be best placed to innovate without risk.
Music is a performance tool, a brand asset and a powerful lever for engagement. The examples above show that this applies at every scale, from a single boutique studio to a global combat sports brand.
The most successful innovators understand that when music and movement align, something special happens. With the right technology and licensing in place, that can scale.
About Con Raso, Managing Director of Tuned Global
Con Raso is an entrepreneur passionate about innovation, new technologies, and start-ups.
Over the last few decades he has focused on creating innovative mobile and online distribution models within the B2C entertainment market, enabling brands to utilise music as a marketing tool, via unique customer engagement strategies.
Being inherently well-versed in both technology and music, Con ensures our solutions are aesthetically pleasing, engaging and disruptive.
About Tuned Global
Tuned Global is the leading data-driven Cloud Music Platform that empowers businesses to integrate commercial music into their apps or launch complete streaming experiences using advanced APIs, real-time analytics, licensing solutions, music intelligence and customisable white-label apps.
Our turnkey solutions for music, audio, and video, coupled with a broad ecosystem of third-party music tech integrations, make us the most comprehensive platform for powering digital music projects.
We streamline complexities in licensing, rights management, content delivery and music discovery, enabling rapid innovation and bringing new ideas to life.
Since 2011, we’ve supported 40+ companies in 70+ countries — across telecom, fitness, media, aviation, and more — to deliver innovative music experiences faster and more cost-effectively.
For more information, visit www.tunedglobal.com.
Only 18 per cent of UK workplaces have a menopause policy, according to a new survey. while half of 1,000 women said they feel supported during menopause at work.
The study found that 37 per cent of respondents said their employer does not provide any menopause support at all.
The new study, commissioned by women’s wellness specialist Serenova for International Women’s Day, surveyed perimenopausal, menopausal or post-menopausal women aged 30 or over.
Elle Sheppard, global head of marketing and communications at Serenova, said: “Mid-life women have so many pressures to face, the last thing they need is to feel like they have to suffer in silence at work, or worse, get forced into leaving a career they love due to a lack of support.
“Going through the menopause, including the peri and post stages, can last for years; this isn’t just a ‘flash in the pan’ day when you don’t feel your best, it’s a long period of lacking confidence, feeling exhausted and putting up with physical pain too.
The findings come as the government launched its gender pay gap and menopause action plan guidance on 4 March 2026, which will be compulsory for large businesses by April 2027.
Women working in healthcare and social services reported feeling the most supported, with 57 per cent agreeing they feel “somewhat” or “very” supported.
This was followed by public services, law and security at 53 per cent, education and non-profit at 52 per cent, and business, finance and professional services at 48 per cent.
Women working in retail reported feeling the least supported, at 44 per cent.
Among healthcare and social services workers, 36 per cent said their employer does not provide any support provisions, 22 per cent said their workplace had a menopause policy and 16 per cent said their employer provided counselling support. Just 7 per cent had access to menopause leave.
In comparison, 15 per cent of retail workers said their workplace had a menopause policy, 8 per cent had counselling and 10 per cent had menopause leave.
This was higher than in healthcare and social services, where just 7 per cent had menopause leave.
Regionally, workers in London reported feeling the most supported, with 59 per cent agreeing they feel “somewhat” or “very” supported, nine per cent higher than the national total.
The South East followed at 55 per cent, while Yorkshire and the Humber ranked lowest at 45 per cent.
Sheppard said: “Serenova was launched on International Women’s Day last year, with a goal of helping women take charge of their wellbeing so they can navigate this life phase with clarity and confidence.
“As we celebrate our first anniversary, we wanted to find out how supported women really feel, to shine a light on the reality of navigating midlife as a woman.”
A new daily menopause pill approved for NHS use could bring relief to women with debilitating hot flushes and night sweats.
Around 500,000 women are expected to be eligible for the treatment, which experts say could help those unable to take hormone replacement therapy, or HRT.
The drug, fezolinetant, also known as Veoza, is a daily non-hormonal tablet designed to target the brain signals that trigger some of the most disruptive menopause symptoms.
In final draft guidance published today, the National Institute for Health and Care Excellence recommended the 45mg tablet for women experiencing moderate to severe hot flushes and night sweats.
More than two million women in the UK are thought to suffer these symptoms during menopause, often beginning during the earlier stage known as perimenopause.
For many, the effects are severe, disrupting sleep, affecting concentration and straining relationships. In some cases women are even forced to cut back on work.
An estimated 60,000 women in the UK are currently out of work or on long-term sick leave due to severe menopause symptoms, costing the economy roughly £1.5bn a year.
Research also suggests one in 10 women has left the workforce entirely because of a lack of support.
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