Actegy Ltd, R (on the application of) v The Advertising Standards Authority Ltd & Anor

CE certification under the medical-devices regime authorises a product to be placed on the market. It does not, by itself, substantiate efficacy claims made in an advertisement. Advertising controls under the Unfair Commercial Practices Directive operate separately from the medical-devices regime.

An advertising regulator may require rigorous and relevant evidence, assess the quality as well as the quantity of evidence, and consider the totality of the material. Relevant considerations may include equivalence between tested and advertised devices, mode of use, target consumers, methodology and sample sizes. Judicial review remains supervisory: the court must not substitute its scientific assessment for that of the regulator.

The claimant manufactured and advertised the Revitive DX medical device. Following complaints, the Advertising Standards Authority upheld complaints that efficacy claims concerning improved circulation and reduced pain, swelling and discomfort were misleading or inadequately substantiated.

The claimant sought judicial review of the ASA’s ruling and of the Independent Reviewer’s refusal to recommend reconsideration. It argued that the ASA had applied an excessive and disproportionate evidential standard, had acted irrationally and unfairly, and had unlawfully disregarded CE certification under the Medical Devices Directive.

1. Outcome. The claim against both defendants was dismissed. No discrete challenge to the Independent Reviewer’s reasoning had been advanced. In any event, if the ASA’s decision survived, the claim against the Independent Reviewer would also fail and would be academic (paras [75]-[86], [132]).
2. Scope of the review. The ASA is a non-statutory body amenable to judicial review. The court exercises only a supervisory jurisdiction and will interfere on conventional grounds such as irrationality, illegality or procedural impropriety. It will not substitute its own judgment where the regulator’s interpretation and assessment fall within a reasonable range (paras [35]-[48]).
3. Separate regulatory regimes. The Medical Devices Directive concerns authorisation to place a device on the market. The Unfair Commercial Practices Directive concerns misleading commercial practices and permits or requires controls on advertising. CE certification therefore did not automatically substantiate advertising claims, and the ASA was entitled to assess the evidence independently (paras [47]-[49], [102]-[104], [130]).
4. Evidence and proportionality. The ASA was entitled to require evidence that was rigorous in methodology and relevant to the advertised device, users and uses. It was not required to accept the conclusions of the clinical evaluation or to treat evidence of moderate or low quality as sufficient. The ASA had assessed the evidence as a whole, while giving proper attention to equivalence, mode of use, consumer groups, blinding, sample sizes and other methodological issues. That approach was rational and did not impose a requirement that only a single high-quality randomised controlled trial could suffice (paras [89]-[104], [114]-[130]).
5. Proportionality and fairness. The analysis pursued the legitimate objective of consumer protection, was suitable and necessary, and was not shown to be more restrictive than an identified alternative. No unfairness or legal error was established (para [129]).