The short answer: maybe.
Annoying, I know.
Whether your product is a medical device starts with what you say it does (Intended Use). If you claim to diagnose, prevent, monitor, treat or relieve a disease or condition, to change how the body works, or for contraception, you’re most likely in device territory in the US, the EU and the UK. Regulators read those claims from everything you publish, not just your label. But what the product actually is can also settle the question for you, however carefully you word things.
Women’s health makes this harder than most fields. Periods, fertility, pregnancy, pelvic health and menopause sit right on the line between normal physiology and pathology, and the words you use (“track”, “support”, “manage”, “prevent”) matter.
The claim decides… until the technology does
Two products can share a sensor, an algorithm and a Bluetooth chip and still end up with different classification and route to market. For low-risk technology, the Intended Use is your North Star: what your device does, how it works, and who it's for.
Take a cycle-tracking app. If its Intended use is to log your periods and predict the next one, it’s an unregulated (or wellness) product in most markets. If you use that same algorithm to predict and display 'safe days' as birth control, you’re making a regulated medical device: Natural Cycles is cleared by the FDA as a Class II device and CE-marked as Class IIb in Europe.
Or a breast pump. “... extract milk from the breast of a lactating woman for the purposes of infant feeding” does not have any inherent medical purpose, according to EU and UK regulators (FDA is a different story here, more on that below). “... extract milk from the breast of a lactating woman for the purposes of preventing engorgement and mastitis” is a medical claim, which moves your breast pump firmly over to the device side.
Wearables work the same way. Showing heart-rate or temperature trends can be wellness. The moment your app calls a reading “abnormal”, names a condition, or tells someone to act clinically, the identical hardware becomes a device.
Sometimes, you really do have a choice as to whether you position your product as a wellness product or a medical device, but this usually comes with some tradeoffs.
When the technology decides for you
The examples above may fall on either side of the line because the underlying technology itself is low risk and noninvasive. Sometimes the technology or form factor will be considered a medical device, regardless of what your claims say.
In the US, the FDA’s 2026 wellness policy doesn’t stretch to anything invasive (even minimally: its own example is a microneedle glucose sensor) or to technology that poses a safety risk, regardless of what you claim. Europe has its own version of this in Annex XVI of the MDR: a list of product groups with no medical purpose that still have to meet device requirements, from high-intensity light equipment for hair removal to equipment for reducing body fat.
A good first test is this: if your product goes into the body, sends energy into it, or changes how it works, look hard at the technology before you spend any time polishing the copy.
How the US, EU and UK decide
All three start from intended purpose. Where they differ is how much room they leave for wellness.
In the US (FDA)
The test: intended use, judged objectively from labelling, marketing and other statements, and compared against hundreds of product codes for a match.
Wellness carve-out: yes. An explicit low-risk policy for general wellness products, updated in January 2026 to cover some non-invasive wearables that measure things like blood pressure or heart-rate variability.
Key guidance: General Wellness: Policy for Low Risk Devices
In the EU
The test: intended purpose under the Medical Device Regulation (EU) 2017/745, whose definition explicitly includes the “control or support of conception”.
Wellness carve-out: no formal carve-out. A product with no medical purpose is simply not a device (with certain exceptions).
Key guidance: MDCG 2019-11 Rev.1 for software (June 2025)
In the UK (Great Britain)
The test: technically: intended purpose under the UK Medical Devices Regulations 2002; for more practical purposes, usually aligned with EU-MDR
Wellness carve-out: no formal carve-out. The MHRA states that general disclaimers do not override medical claims made elsewhere.
Key guidance: MHRA borderline manual
Two things here are relevant for women’s health. First, the EU definition names “control or support of conception” outright, so fertility and contraception products don’t get to argue that conception is normal physiology, not a disease or condition. Second, the FDA’s 2026 update gives some US wearables more room than they’d get in Europe, which can make the US the easier first market for a sensor-based wellness product, and the harder one for others, as you’ll see below. (Northern Ireland, for the record, follows rules closer to the EU’s.)
Same product, different answers
Here’s how five common women’s health products tend to land. Use it to get your bearings, not as a ruling: your exact claims and design decide your status.
Period-tracking app that logs and predicts periods
US: generally not regulated as a device
EU: not a device (no medical purpose)
UK: not a device
App marketed as digital birth control (e.g. Natural Cycles)
US: device, Class II
EU, UK: device, Class IIb
Breast pump for feeding
US: device (Class II if powered)
EU: depends on the intended purpose the manufacturer declares. Infant feeding is not a medical purpose; preventing mastitis would be a medical purpose
UK: not normally a device; it is one if a medical purpose is claimed, such as treating inverted nipples
Electrical stimulator to treat female stress urinary incontinence
US: device, Class II
EU: device, Class IIa
UK: device (CE mark accepted)
Electrical muscle stimulator sold for “toning”
US: device. The FDA regulates muscle stimulators for toning.
EU: not a medical device without a medical claim
UK: not a medical device without a medical claim
Take-home message: an identical device may be a regulated device in one market and a consumer product in another. Consumer products don’t get a free pass, either - different standards may apply, especially around consumer product safety and truth in advertising. If you’re planning a multi-market launch, identifying your product testing and safety requirements early can save you headaches later.
Words that tip you over the line
Most borderline products don’t cross the line in their engineering. They cross it in their marketing copy, often without noticing. Here’s how small the gap can be.
In each pair below, the first usually reads as wellness; the second usually reads as a medical device.
“Track your cycle and see predicted period dates” → “Know your fertile days to avoid conceiving, or increase your chances of pregnancy”
“Build pelvic floor strength” → “Treat stress urinary incontinence”
“See your heart-rate and temperature trends” → “Detect an abnormal reading, or alert you to a condition”
“Understand how sleep and stress affect how you feel” → “Diagnose, screen for or monitor a named condition”
“Talk to your doctor if you have questions” → “Tells you when to start, stop or change a treatment”
A few things catch even careful teams. Your claims aren’t just on your label: regulators look at your website, app store listing, packaging, push notifications, social posts, and what your ambassadors say on your behalf. A disclaimer won’t save you either. Writing “not a medical device” in the footer doesn’t cancel a medical claim on your homepage or your socials.
And claims tend to drift. A product that launched with careful wellness copy picks up medical language one campaign at a time, until one day it isn’t a wellness product anymore. Reviewing your claims is a standing job, not a launch task.
Where I’d start
If you’re not sure which side of the line you’re on, this is what I’d do first.
Write your intended purpose in one sentence, before you write your website: what the product does, for whom, and why. Everything else follows from it. Our free device positioning tool will draft one with you and flag what you still need to decide.
Check every place you make claims against that sentence: site, app store, packaging, emails, social and partners.
Choose your first market on purpose. The same product can be wellness in one market and a device in another, so the right order depends on your claims, your evidence, and where your buyers and investors are.
Write down why you are (or aren’t) a medical device. Investors, notified bodies and retailers will ask, and a referenced one-pager is a lot more convincing than “our lawyer said it was fine”.
I’ve been on the operator side of these decisions, and I know how much easier they are to get right early than to fix later. If you’d like a second pair of eyes on where your product sits, book a free 30-minute call. I’d love to help.
Sources
US FDA, General Wellness: Policy for Low Risk Devices (updated January 2026)
US FDA, Electronic Muscle Stimulators (consumer information page, content current as of December 2017)
European Union, Regulation (EU) 2017/745 on medical devices
European Commission, MDCG 2019-11 Rev.1: qualification and classification of software (June 2025)
MHRA, Borderlines with medical devices and other products in Great Britain
Natural Cycles, certifications behind NC Birth Control
This article is general information, not regulatory advice for a specific product. Status as of November 2026.