Products and machines carry a lot of vocabulary: approved, certified, medical grade, clinically proven, patented. Each of these words has either a specific meaning, a vague one, or none. Sorting them takes a few minutes and it is the same method each time.
Get the name first
Nothing can be checked without a name. Ask, in writing, for the full product or device name and the manufacturer. A clinic proposing to inject something into your face, or to use a machine on your skin, can name it.
If the answer is a treatment brand rather than a product, ask again for the product and manufacturer. Treatment names are marketing labels and are frequently applied to different underlying products in different places.
- Open
- The Medicines and Healthcare products Regulatory Agency on GOV.UK
gov.uk, MHRA guidance and the Yellow Card scheme at yellowcard.mhra.gov.uk - Type in
- The full product name and manufacturer as given to you in writing. Look for the product category, whether it is regulated as a medicine or a device, and any published safety information.
- A good result looks like
- Clear information about how the product category is regulated, and a route to report a problem, so that you can describe the product accurately rather than by its treatment name.
- An ambiguous result looks like
- A treatment brand name that does not correspond to any product you can identify. A clinic unwilling to name the manufacturer. Claims of approval that name no approving body.
- What it does not prove
- That the product is suitable for you, that the practitioner is trained to use it, or that a cosmetic result has been endorsed by any regulator.
- Note
- Whatever you find, ask that the product name and batch number are written in your notes on the day.
Regulatory status claims
The Medicines and Healthcare products Regulatory Agency is the UK regulator for medicines and medical devices. Two distinctions are worth carrying.
Medicines are authorised. A medicine placed on the UK market holds a marketing authorisation, and authorised medicines have public information about their approved uses. Botulinum toxin products are prescription only medicines, which is why they cannot be advertised to the public.
Devices are conformity assessed. Devices are placed on the market under conformity assessment procedures with a marking such as UKCA or CE. That process relates to the product meeting requirements for being placed on the market. It is not a regulator's endorsement of a cosmetic result, and it says nothing at all about the person using the device on you.
So the sentence it is fully approved means different things depending on which category the item is in, and often means less than the speaker intends. Ask which category, and by whom.
Clinical evidence claims
Clinically proven is not a regulated phrase and is used across a wide range of underlying evidence. The way to test it is to ask a single question: which study, and where can I read it.
What you are looking for is a traceable reference. A published paper in a journal, with authors and a date, that you can look up. Where a claim is significant to your decision, that reference is a reasonable thing to ask for, and advertisers should hold evidence for objective claims before making them, as set out in the advertising article.
Two cautions once you have a reference. Study populations may not resemble you, and a study of one product does not support claims about another. And a study funded by a manufacturer is not thereby worthless, but the funding is a fact you should know and it is usually declared in the paper.
Where a treatment has been examined by a national body such as NICE, that assessment is public and readable, and it is a more useful source than a marketing summary of it.
| Claim | What it can mean | The question that tests it |
|---|---|---|
| Approved | Authorised as a medicine, or conformity assessed as a device | Which category, and by whom |
| Clinically proven | Anything from a published trial to an in house test | Which study, and where can I read it |
| Medical grade | No defined regulatory meaning here | What do you mean by that |
| Patented | A property right over an invention | What does the patent claim, and how is that relevant to results |
| Recommended by professionals | Anything or nothing | Which professionals, and on what basis |
| Award winning | Depends entirely on the award | Which award, given by whom, judged how |
A framework written by this publication to organise the procedure. It is not a measurement, a guideline or a regulator's classification.
Vocabulary that means nothing in particular
Some terms carry no defined regulatory meaning in this context and should be treated as description rather than credential.
- Medical grade. Not a defined regulatory category for cosmetic products. Ask what is meant.
- Pharmaceutical grade. Similarly undefined in this usage.
- Patented. A patent is a property right over an invention. It is not evidence that the invention works.
- Award winning. Ask which award, given by whom, and on what basis.
- Advanced or next generation. Marketing language, carrying no defined content.
None of these means a product is bad. They mean the words are not doing the work people assume, and that the actual question, which is what the product is and what evidence supports the claim, has not yet been answered.
Supply chain, briefly
For medicines, the supply route matters, and products obtained outside proper channels are a genuine concern that the MHRA takes seriously. You are entitled to ask that the product name and batch number are recorded in your notes, and to be shown the packaging.
For devices, the same request is reasonable. A clinic that records product and batch as routine practice is doing what a well run service does, and it is also creating the record you would need if anything went wrong. See records and photographs.
Reporting a problem with a product
The MHRA Yellow Card scheme receives reports about suspected side effects of medicines and about adverse incidents involving medical devices, and patients can report directly. It needs the product name and ideally the batch number, which is the second reason to have recorded them.
Reporting is one of the few things a single patient can do that contributes to detecting problems affecting other people. It takes a few minutes and requires no permission from anyone. What else to do at that point is in what to do when something goes wrong.