A website, www.trionz.co.uk, which advertised bracelets, stated "No.1 sports health bracelet ... CE Marked as Class 1. Tried and trusted for seven years".
The complainant challenged whether the claim "CE Marked as Class 1" was misleading and could be substantiated.
Arc Quest Co Ltd t/a Trion:Z (Trion:Z) provided a copy of an EC Declaration of Conformity which stated that a range of Trion:Z products met "the provisions of the Council Directive 93/42/EEC for Medical Devices", and a letter from the Netherlands Ministry of Public Health, Welfare and Sports which confirmed the registration of Trion:Z's products as Class I medical devices under European Directive 93/42/EEC.
The ASA understood that the EC Medical Devices Directive included a classification system whereby the level of regulatory control applied to devices was proportionate to the degree of risk associated with the device. Class I was for low risk devices, for which manufacturers could complete the conformity assessment process themselves. Devices were then allowed to carry a CE mark and could be freely marketed throughout the EU.
We noted the certification information provided by Trion:Z and considered it demonstrated that the Trion:Z bracelets were CE marked as Class I medical devices in the EU. We therefore concluded the ad did not breach the Code.
We investigated the ad under CAP Code (Edition 12) rules 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. (Misleading advertising) and 3.7 3.7 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation. (Substantiation), but did not find it in breach.
No further action necessary.