What is not a medical device?
This page is based on the definition in Regulation 2(1) of the UK MDR 2002 and MHRA's published borderline guidance. A product that does not meet the definition of a medical device — or falls within a recognised exclusion — is not subject to UK MDR 2002 requirements.
This site provides general information only and does not constitute legal or regulatory advice. Borderline determinations can be complex and fact-specific. Always consult MHRA's borderline guidance and, where appropriate, a qualified regulatory professional.
The principle: intended purpose is determinative
Whether a product is a medical device depends almost entirely on its intended purpose — what the manufacturer claims or implies the product does, through labelling, instructions for use, promotional materials, and any other means.
The same physical product can be:
- A medical device if the manufacturer claims a medical purpose
- Not a medical device if the manufacturer makes no medical claims
This means that regulatory status is partly a choice made by the manufacturer — but manufacturers who make medical claims for products that are not suitably designed, tested, and assessed risk enforcement action by MHRA.
Products that are not medical devices
1. Medicinal products
Products that achieve their principal intended action through pharmacological, immunological, or metabolic means are not medical devices — they are medicinal products regulated under the Human Medicines Regulations 2012 and by MHRA's medicines licensing function.
Examples: tablets, capsules, injections, patches delivering a pharmacological agent, vaccines, monoclonal antibody treatments.
A product may be partly medicinal and partly a device (combination products). See Devices incorporating a medicinal substance.
2. Cosmetic products
Products intended solely for cosmetic purposes — improving appearance without a medical purpose — are regulated under the UK Cosmetics Regulation (Retained Regulation (EC) No 1223/2009), not UK MDR 2002.
Examples: moisturisers, lipstick, hair dye, non-prescription sunscreen (for cosmetic use only).
However: A product can cross into medical device territory if it makes claims that go beyond cosmetics — for example, a cream that claims to treat eczema or psoriasis rather than simply moisturise.
In the EU, certain cosmetic/aesthetic devices — non-corrective contact lenses, dermal fillers for cosmetic use, lipolysis equipment — are regulated as medical devices under Annex XVI of EU MDR 2017/745. The UK MDR 2002 does not have an equivalent provision. These products are not currently regulated as medical devices in Great Britain. This is a meaningful difference for manufacturers of these product types.
3. Biocidal products
Products intended to destroy, deter, or control harmful organisms (bacteria, fungi, insects) by chemical or biological means are biocidal products regulated under the UK Biocidal Products Regulation (retained EU BPR 528/2012).
Examples: disinfectants for environmental surfaces, rodenticides, insect repellents, preservatives.
However: A medical device that incorporates an antimicrobial or antifouling substance where that substance plays an ancillary role (e.g., an antibiotic-impregnated catheter where the catheter function is primary) may still be a medical device. The principal mode of action is key.
4. Food and nutritional products
Products ingested as food, supplements, or nutrition — intended to nourish or support general health — are regulated as food products under the Food Safety Act 1990 and related regulations, not UK MDR 2002.
Examples: vitamins, minerals, protein supplements, functional foods, probiotic yoghurt.
However: If a supplement makes claims to diagnose, prevent, treat, or alleviate a specific disease, it risks being characterised as an unlicensed medicinal product or a medical device depending on its mode of action.
5. Lifestyle, wellness, and general-purpose products
Products intended for general wellness, fitness, or lifestyle improvement — without specific medical claims — are not medical devices.
Examples:
- Fitness trackers measuring steps or general activity (no medical diagnostic claim)
- Smart scales measuring body weight without medical diagnostic output
- General-purpose pulse oximeters sold as fitness accessories without clinical accuracy claims
- Blue-light-blocking glasses without therapeutic vision claims
- Air purifiers marketed for general air quality (not as medical treatment)
- Posture support cushions marketed for comfort (not for treatment of a condition)
The line: Add a medical purpose claim and the same product may become a medical device. A consumer wearable that simply counts steps is not a medical device. The same wearable marketed to detect atrial fibrillation and alert a clinician is.
6. Veterinary devices
Devices intended solely for use on animals are not medical devices under UK MDR 2002 (which covers devices for human beings only). Veterinary devices may be subject to other legislation but are outside MHRA's scope.
7. Non-medical laboratory equipment
General-purpose laboratory equipment — centrifuges, pipettes, microscopes, spectrophotometers, incubators — used in scientific research without a specific intended purpose of examining human specimens for diagnostic purposes is not an IVD medical device.
The same equipment, if marketed and intended by the manufacturer specifically for use in clinical diagnostics on human specimens, may qualify as an IVD.
8. Research tools
Reagents, chemicals, or instruments sold exclusively "for research use only" (RUO) — with a clear RUO declaration and no claims of clinical utility — are not medical devices. They are intended to support scientific investigation, not to diagnose or treat.
Important caveat: RUO labelling does not automatically exempt a product. If a manufacturer knows that their RUO-labelled product is being used clinically (e.g., used in patient diagnosis without further validation), MHRA may consider them to be effectively placing a medical device on the market without compliance.
9. Disabled aids without medical purpose
Certain assistive products — walking sticks, grab rails, bath lifts — may assist persons with disabilities without constituting medical devices, provided no medical diagnostic or therapeutic claims are made. Classification depends on the specific claims and whether the product is intended to compensate for an injury or disability (medical purpose) or simply provide general assistance.
Borderline products — where lines blur
Several categories sit at the boundary between medical devices and other regulatory frameworks. MHRA publishes borderline guidance and can provide informal opinions on specific products.
Drug-device combination products
Products combining a medicinal substance and a medical device element where both contribute to the product's purpose. The primary mode of action determines which regulatory framework leads:
- Device-led → regulated as medical device under UK MDR 2002 (with MHRA input on the medicinal component)
- Medicine-led → regulated as medicinal product under Human Medicines Regulations 2012 (with relevant device standards applied to the device component)
Software and apps
Software is explicitly within the medical device definition, but not all health-related software qualifies. Software that merely stores, archives, or transmits data without interpretation is not a medical device. Software that analyses data and outputs a result that informs clinical decisions likely is. See Software & AI as a medical device.
Dental products
Some dental products (toothpastes, mouthwashes) are cosmetics or medicines. Dental instruments and implants are medical devices. Whitening products above a certain hydrogen peroxide concentration are borderline between cosmetics and medicines.
Contact lenses
Corrective contact lenses (prescription) are medical devices under UK MDR 2002. Non-corrective (cosmetic/coloured) contact lenses are currently not regulated as medical devices in Great Britain — unlike in the EU, where they fall under Annex XVI of EU MDR 2017/745. MHRA's reform programme may address this gap.
Near-patient testing (NPT) kits sold to professionals
Kits sold exclusively to healthcare professionals for use in a clinical setting are IVD medical devices. The same kits sold to members of the public are self-test IVD medical devices with additional requirements.
Getting a borderline opinion from MHRA
If you are uncertain whether your product is a medical device, MHRA offers a pre-submission meeting service through which manufacturers can seek informal guidance on borderline questions before making a regulatory decision. This is not a formal binding determination, but it is the most reliable way to get MHRA's current thinking on your specific product.
Contact: MHRA pre-submission service
MHRA also participates in the Borderline and Classification Section (BCS) network of European regulators, even post-Brexit, and publishes borderline product assessments on gov.uk.
Related pages
- What is a medical device?
- What is an IVD?
- Software & AI as a medical device
- Devices incorporating a medicinal substance
- Great Britain vs Northern Ireland — Annex XVI gap between GB and NI
Official references
| Reference | Description |
|---|---|
| UK MDR 2002, Reg 2(1) | Definition of medical device — basis for all exclusion analysis |
| Human Medicines Regulations 2012 | Medicinal product framework |
| UK Cosmetics Regulation (retained) | Cosmetic product framework |
| UK Biocidal Products Regulation (retained) | Biocidal product framework |
| MHRA: Borderline products guidance | MHRA guidance on products that may or may not be medical devices |
| MHRA: Pre-submission meetings | How to request a borderline opinion from MHRA |