Decision Tree: Is a Cosmetic Device a Medical Device under UK MDR 2002?
Decision Tree: Is a Cosmetic Device a Medical Device under UK MDR 2002?
The following decision tree is designed to help determine if a cosmetic device will be regulated as a medical device in the UK.
The device is a Medical Device if:
1. It is intended for human use, and
2. It works primarily by physical mode of action, and
3. It has an intended medical purpose (explicit or implied).
If all three criteria are satisfied, then it is regulated as a Medical Device under UK MDR 2002¹.
If one or more of these three criteria is not satisfied, then it is not a Medical Device (likely to be either a cosmetic, a consumer product or a medicinal product).
1. Is the product intended for human use¹?
NO → Not a medical device.
YES → Proceed to Step 2.
2. Does the product achieve its primary intended action by physical means¹?
NO → Not a medical device.
(If the primary action is chemical, metabolic, or immunological, it may be either a cosmetic or a medicinal product).
YES → Proceed to Step 3.
Examples of physical mode of action:
Light (LED, IPL, laser)
Heat or cooling (Monopolar RF, Bipolar RF, cryotherapy)
Mechanical action (microabrasion, microneedling, vibration, suction)
Ultrasound (HIFU high-intensity focused ultrasound, MFU micro-focused ultrasound)
Electrical stimulation (EMS, microcurrent)
3. Does the manufacturer claim, imply, or design the product for an intended medical purpose¹?
NO → Not a medical device. (Likely to be a cosmetic device or consumer beauty device).
YES → Medical Device
A medical purpose includes:
Diagnosis, prevention, monitoring, treatment, or alleviation of disease
Diagnosis, monitoring, treatment, alleviation, or compensation for an injury or handicap
Investigation, replacement, or modification of anatomy or of a physiological process
Control or support of conception
The device does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means.
Examples of medical purpose claims: ² ³
“Treats acne”
“Prevents spots”
“Reduces pain or inflammation”
“Improves circulation”
“Enhances muscle strength and endurance”
“Treats scars or rosacea”
“Stimulate collagen production”
“Attacks hair at the root, impeding the growth of more hair”
“Thermocoagulation treatment for facial thread veins”
“Vagus nerve stimulation”
“Boost cellular energy production”
“Treat musculoskeletal pain”
“Treat arthritis”
“Mitochondrial stimulation and ATP production”
4. MHRA Advice⁴
The MHRA will provide manufacturers with advice on whether a product is a medical device. If the manufacturer is not sure they should approach the MHRA for advice. The MHRA will review:
the intended purpose for the product, including the claims about what the product is and what it does (explicit and implicit)
the mode of action of the product (how it works)
how the product is presented to the public through labelling, packaging, promotional literature and advertisements, including websites
whether there are any similar products on the market and how they are regulated
5. Conclusion
Making a clear distinction between cosmetic and medical device can be challenging. This decision tree is designed to help determine if the device falls under the Medical Device regulations in the UK. Medical devices must meet all three criteria (i) human use, (ii) a physical mode of action and (iii) a medical purpose. Claims of medical benefits such as tissue repair, rehabilitation, and functional improvement, make it a medical device. It is essential that the device is correctly classified to ensure regulatory compliance. If the device manufacturer is unsure then it is recommended that they seek advice from the MHRA in order to ensure they remain compliant.
6. References
1. The Medical Devices Regulations 2002. (2020). Legislation.gov.uk. UK MDR 2002, Part I, Section 2(1), https://www.legislation.gov.uk/uksi/2002/618/regulation/2
2. GOV.UK. (2023, May 4). Regulation 2009/1223 and the Cosmetic Products Enforcement Regulations 2013: Great Britain. https://www.gov.uk/government/publications/cosmetic-products-enforcement-regulations-2013/regulation-20091223-and-the-cosmetic-products-enforcement-regulations-2013-great-britain
3. MHRA Guidance Note 8 A guide to what is a medicinal product. (2025). https://assets.publishing.service.gov.uk/media/68cad9711eabc899da7084f1/MHRA_GN8.pdf
4. Borderline products: how to tell if your product is a medical device and which risk class applies. (2023, July 11). GOV.UK. https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medical-device
