Optident Limited and Another v. Secretary of State for Trade and Industry

A cosmetic product covered by Council Directive 76/768/EEC is excluded from Council Directive 93/42/EEC on medical devices. The attachment of a CE marking cannot bring such a product within the medical-devices regime or prevent national authorities and courts from determining its proper classification.

Classification as a cosmetic depends principally upon the product’s intended purpose, rather than whether its effects are temporary, superficial or reversible. A product intended for contact with teeth mainly to change their appearance is a cosmetic product. References in the definition to different body parts are disjunctive.

Opalescence was a tooth-bleaching gel containing carbamide peroxide which released substantially more hydrogen peroxide than the maximum permitted for oral-hygiene products under Council Directive 76/768/EEC. Its manufacturer obtained certification from a German notified body and applied a CE marking under Council Directive 93/42/EEC. United Kingdom authorities nevertheless prohibited its supply as a cosmetic product.

Laws J held that the CE marking had to be respected unless challenged in the state where it was granted and that Opalescence was not a cosmetic. The Court of Appeal unanimously reversed that decision, holding that the product was a cosmetic and therefore excluded from the medical-devices regime.

The central issues before the House were whether a CE marking prevented national authorities from classifying the product as a cosmetic, and whether Opalescence fell within the Cosmetics Directive.

1. Appeal dismissed unanimously. Lord Slynn of Hadley delivered the leading speech. Lord Steyn, Lord Hope of Craighead, Lord Clyde and Lord Hutton agreed with his reasons and conclusion.

2. Per Lord Slynn, the regimes created by Council Directive 76/768/EEC and Council Directive 93/42/EEC were separate and distinct. Article 1(5)(d) of the latter meant that none of the Medical Devices Directive applied to a cosmetic product covered by the Cosmetics Directive. The earlier directive established a detailed and self-contained code for cosmetics, while the later directive prescribed a different system based on essential requirements, product classes and conformity assessment.

3. Per Lord Slynn, attaching a CE marking did not deprive national authorities or courts of competence to determine whether a product was truly a medical device. A notified body principally performed verification and audit functions. It had no jurisdiction conclusively to determine whether a product fell within the Medical Devices Directive. This was especially clear for Class I devices, for which the manufacturer attached the marking without intervention by a notified body. Protection under Article 4(1) required the product to be a medical device and not a cosmetic.

4. Per Lord Slynn, Articles 8 and 18 did not require a cosmetic bearing a CE marking to be treated as a medical device. A marking wrongly attached under the Medical Devices Directive could not bypass the possibly more stringent conditions imposed by the Cosmetics Directive.

5. Per Lord Slynn, Opalescence was a cosmetic product. The references in the statutory definition to teeth and oral mucous membranes were disjunctive. It was sufficient that the product was intended for contact with the teeth. Its principal intended purpose was to change or restore their appearance. Classification did not depend upon its effects being temporary, superficial or reversible. Nor did use to ameliorate a troublesome condition prevent classification as a cosmetic.

6. Per Lord Slynn, it was unnecessary to decide whether Opalescence could otherwise satisfy the definition of a medical device. The relevant questions of Community law were sufficiently clear to make a reference under Article 234 of the EC Treaty unnecessary. Questions of fact remained for the national court. The United Kingdom had therefore committed no breach of Article 4 by preventing the product’s marketing and had complied with its obligations under the Cosmetics Directive.

1. House of Lords: Dismissed the appeal unanimously and affirmed the Court of Appeal’s conclusion that Opalescence was a cosmetic product excluded from the Medical Devices Directive.

2. Court of Appeal: Unanimously allowed the respondents’ appeal. It held that Opalescence was a cosmetic product and therefore could not fall within the Medical Devices Directive.

3. High Court (Laws J): Held that the CE marking brought Article 4 of the Medical Devices Directive into operation unless successfully challenged in the state where the marking was obtained. He also held that Opalescence was not a cosmetic product and that the respondents had infringed Article 4.