Marketing category, regulatory category

1.4.1Two routes to market, and what each demands

A licensed medicine reaches the UK market through a marketing authorisation. The manufacturer must demonstrate quality, safety and efficacy for defined indications, generally through a staged clinical trial programme, and the regulator scrutinises and approves the specific claims that may be made. The permitted indications are written down. Advertising a licensed medicine is tightly constrained, and prescription only medicines cannot be advertised to the public at all.

A medical device reaches the market differently. The manufacturer compiles a technical file demonstrating that the device is safe and performs as intended, undergoes a conformity assessment appropriate to its risk class, and applies a UKCA or CE mark. Higher risk classes, which include injectable implants of this general kind, involve a notified or approved body rather than self declaration, and the assessment is genuinely substantial. What it is not is an efficacy licence. The question asked is whether the device does what the manufacturer says it does at the level of performance, and whether it is safe. It is not whether it produces a particular cosmetic outcome that a clinic will later advertise.

Neither route is a formality and neither is a rubber stamp. They ask different questions, and the answers therefore support different statements.

1.4.2What a mark on the box entitles anyone to say

A UKCA or CE mark tells you that a conformity assessment has been carried out against the applicable requirements. It tells you there is a manufacturer with a registered address, a technical file, and obligations for post market surveillance and vigilance reporting. Those are meaningful things and a product without them should worry you.

It does not tell you that a regulator has reviewed evidence that the treatment improves skin quality, reduces fine lines, or produces any other outcome a clinic may advertise. Claims of that kind are advertising claims, and the body that polices them in the United Kingdom is not the MHRA but the Advertising Standards Authority, applying the CAP Code. Under that code the advertiser must hold documentary evidence for objective claims before making them, and rulings on cosmetic treatment advertising are published and searchable.

1.4.3What follows for a patient

Three things, and they are all practical.

First, the phrase clinically proven should be treated as an advertising phrase rather than a regulatory one. It has no fixed meaning, and it does not indicate that any regulator has assessed a clinical claim. If you see it, the useful response is to ask what study, in whom, measuring what.

Second, the absence of a licensed medicine framework means that the vigilance data a regulator would hold on a medicine does not exist in the same form. Adverse events involving devices can be reported through the MHRA Yellow Card scheme, and members of the public can report directly, but reporting is voluntary and the resulting picture is incomplete. Read any claim about a low complication rate with that in mind.

Third, the device route is not a loophole and it is not evidence of bad faith. It is the correct route for a great many products that are genuinely devices. The problem is not the route. The problem is the transfer of the credibility of one route onto the claims of another.

1.4.4Products that are neither

There is a third category to be aware of, which is products that are on neither route in the United Kingdom. Aesthetic products travel internationally, and it is entirely possible to encounter a product that is marketed elsewhere and has no UK route. A clinic offering such a product may not present the position clearly, or may not know it.

The single question that resolves it is whether the product carries a UKCA or CE mark and whether you can see the packaging and instructions for use. If the answer involves an explanation rather than a mark, you have your answer.

1.4.5Where the advertising rules bite

Because the regulatory route does not approve claims, the discipline on claims comes from advertising law and the CAP Code. Marketers must hold evidence for objective claims. They must not exaggerate. They must not target advertising for cosmetic interventions at under eighteens. They must not present a procedure as trivial or risk free. Consumer protection law adds a further layer, since misleading a consumer about the characteristics or benefits of a service is capable of being an unfair commercial practice.

The published rulings are worth a reader's time, because they show in concrete terms what the regulator has already decided is unacceptable, and a great deal of it will look familiar from clinic websites.

1.4.6The four questions this article gives you

• What is the product called and who manufactures it?
• Does it carry a UKCA or CE mark, and may I see the packaging and instructions for use?
• When you say approved, approved by whom and for what?
• When you say clinically proven, which study, in whom, and measuring what?

The value of those questions does not lie in catching anyone out. It lies in the fact that a practitioner who has thought carefully about what they inject will find them easy, and a practice built on repeating supplier copy will find them awkward. That difference is informative, and you will notice it within about thirty seconds.