Is My Product a Medical Device? A UK and EU Guide to Borderline Products

Short answer: A product is a medical device if its intended purpose is medical, for example to diagnose, prevent, monitor, treat or alleviate a disease or injury, and it achieves that mainly by physical rather than pharmacological, immunological or metabolic means. The claims you make on your packaging, website and social media are what define the intended purpose, so the same product can be a cosmetic in one brand's hands and a medical device in another's.

Cosmetics, wellness products, food supplements and apps all sit close to the medical device line. Crossing it changes everything: the regulations, the evidence you need, the conformity assessment route and your post-market obligations. Getting the qualification right before launch is far cheaper than fixing it afterwards.

What counts as a medical device?

In both the UK and the EU, a medical device is broadly any instrument, apparatus, software, implant, reagent, material or other article intended by the manufacturer to be used for a medical purpose. Medical purposes include:

• Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
• Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
• Investigation, replacement or modification of the anatomy or of a physiological or pathological process
• Control or support of conception

Two things decide whether your product qualifies: what you say it is for, and how it works.

Test 1: What is the intended purpose?

Intended purpose is what the manufacturer says the product is for. Regulators look at everything you say, not just the label:

• Packaging, labels and leaflets
• Your website and online product listings
• Social media posts, influencer content and adverts
• Sales materials and presentations
• Customer reviews and testimonials that you share or promote

If any of these make a medical claim, regulators may treat your product as a medical device (or a medicine), even if you designed it as a cosmetic or wellness product.

Claims that usually point to a medical purpose

• "Treats", "cures", "heals" or "relieves" a named condition
• "Diagnoses", "detects" or "screens for" a disease
• "Prevents infection" or "reduces the risk of" a disease
• References to symptoms of a condition, for example eczema, psoriasis, acne as a disease, hot flushes, insomnia or atrial fibrillation

Claims that usually stay outside medical device rules

• "Moisturises", "hydrates", "soothes dry skin" (for cosmetics, with evidence)
• "Tracks your steps", "monitors your sleep patterns for general wellbeing" (for wellness apps)
• "Supports a healthy lifestyle"

Test 2: How does it work?

If a product has a medical purpose, the next question is how it achieves its main effect.

• Mainly physical or mechanical action (a barrier film, a gel that cools, a spray that flushes, a dressing that absorbs) points towards a medical device.
• Mainly pharmacological, immunological or metabolic action (it acts chemically on the body) points towards a medicine, which is a much stricter regime.

Some products combine both. In those cases, the principal mode of action decides which framework applies.

Common borderline products

• Moisturiser: usually a cosmetic. It crosses the line if it claims to treat eczema, psoriasis or dermatitis.
• Saline nasal spray: usually a medical device. Adding an active drug ingredient makes it a medicine.
• Mouthwash: usually a cosmetic. It crosses the line if it claims to treat gum disease or infection.
• Fitness or step-tracking app: usually not regulated. It crosses the line if it detects, diagnoses or monitors a condition.
• Personal lubricant: usually a medical device already.
• Head lice treatment: a device or a medicine, depending on whether it works physically or chemically.
• Scar gel: a device or a cosmetic. Claims to treat or reduce scars point to a device.
• Sunscreen: usually a cosmetic. It crosses the line if it claims to protect against skin cancer or a medical condition.

For more examples, see our articles on where wellness ends and wearables begin, intimate wellness products, women's health apps and "medical grade" skincare.

Is software or an app a medical device?

Software can be a medical device in its own right. An app is likely to be a medical device if it is intended to diagnose, monitor, predict or guide treatment of a condition for an individual patient. Examples include apps that analyse heart rhythm, calculate medication doses or assess skin lesions.

Apps for general fitness, wellbeing, record keeping or communication usually are not. As with physical products, the claims you make decide where your app sits. Our UK software as a medical device services explain how we support app developers.

Non-medical products regulated as devices in the EU

The EU MDR also covers some products with no medical purpose at all, because they carry similar risks. These include coloured contact lenses, dermal fillers, some liposuction equipment and certain laser and intense pulsed light equipment used for hair removal or skin treatment. If you work in aesthetics, check whether your products fall into this group.

What happens if you get it wrong?

Placing a medical device on the market as a cosmetic or wellness product can lead to:

• Products being withdrawn or recalled
• Enforcement action from the MHRA, trading standards or EU authorities
• Advertising complaints and rulings
• Relabelling costs and lost stock
• Damage to your brand's reputation

It works the other way too. Some companies treat products as medical devices when they do not need to, taking on unnecessary cost and delay.

How to check whether your product is a medical device

1. Write down the intended purpose in one sentence. What problem does the product solve, and for whom?
2. Audit every claim, everywhere. Include social media, influencer briefs and marketplace listings.
3. Work out the mode of action. Is the main effect physical or chemical?
4. Check the regulator guidance. The MHRA publishes guidance on borderline products and on software and apps. The European Commission publishes a borderline manual.
5. Get a qualification opinion before launch if you are unsure. It is much cheaper than a recall.

Frequently asked questions

Can a cosmetic make medical claims?

No. A cosmetic is intended to clean, perfume, protect, change the appearance of, or keep the skin, hair, nails, teeth or mouth in good condition. If it claims to treat or prevent a disease, it is no longer a cosmetic.

What is the difference between a medical device and a medicine?

Both have a medical purpose. A medical device mainly works by physical or mechanical means, while a medicine mainly works through pharmacological, immunological or metabolic action.

Is a wellness app a medical device?

Usually not, if it is for general wellbeing or fitness. It becomes a medical device if it is intended to diagnose, monitor or treat a medical condition for an individual.

Who decides if my product is a medical device?

The manufacturer is responsible for deciding, based on the intended purpose and mode of action. Regulators can disagree and take enforcement action, so it is important to document your reasoning.

Do claims on social media count?

Yes. Regulators look at all the claims you make, including on social media and in content you share from customers or influencers.

How Taylored Consultancy can help

We work across cosmetics, food supplements and medical devices, so we see borderline products every day. We can review your product and claims, give you a qualification opinion and help you choose the right regulatory route. Get in touch to talk through your product.

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