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

The House of Lords held that the Medical Devices Directive (Council Directive 93/42/EEC) does not apply to products that are cosmetic products within the meaning of the Cosmetics Directive (Council Directive 76/768/EEC). Article 1(5)(d) of the Medical Devices Directive excludes cosmetic products covered by the Cosmetics Directive, and that exclusion must be given its ordinary meaning. The presence of a CE mark under the Medical Devices Directive does not deprive national authorities and courts of their competence to decide that a product is a cosmetic product and to apply the Cosmetics Directive. Applying the legal tests in the Cosmetics Directive (notably Article 1 and Annex I), the Court concluded that Opalescence was a cosmetic product used chiefly to change the appearance of teeth and therefore fell outside the scope of the Medical Devices Directive; the steps taken by the United Kingdom authorities to prevent its marketing were lawful.

Background and parties:

The appellants (Optident Limited and another), exclusive UK distributor of Opalescence (a 10% carbamide peroxide gel releasing about 3.4% hydrogen peroxide), challenged steps by the Secretary of State and the Medical Devices Agency which treated Opalescence as a cosmetic product and prevented its marketing in the United Kingdom. Opalescence was supplied only to dentists and had been CE marked in Germany after Ultradent obtained a certificate from a German notified body.

Nature of the claim:

• The appellants claimed that the respondents had infringed Article 4 of the Medical Devices Directive and Article 30 of the EC Treaty by creating obstacles to the placing on the market or putting into service of devices bearing CE markings. The argument before the House of Lords was confined to Article 4 of the Medical Devices Directive.

Procedural history:

• Preliminary issues were ordered by Popplewell J; Laws J heard them and held that the respondents had infringed Article 4 of the Medical Devices Directive. The Court of Appeal unanimously held that Opalescence was a cosmetic product and therefore excluded from the Medical Devices Directive, meaning the United Kingdom could lawfully prevent its marketing. The appellants appealed to the House of Lords.

Issues framed:

• Whether a product bearing a CE mark under the Medical Devices Directive must be treated as a medical device throughout the Community so as to prevent national authorities treating it as a cosmetic product; and
• Whether Opalescence is a cosmetic product within the meaning of the Cosmetics Directive.

Reasoning and decision:

The Court analysed the two regulatory regimes and found them distinct in purpose and operation. Article 1(5)(d) of the Medical Devices Directive expressly excludes cosmetic products covered by the Cosmetics Directive. The Court rejected the appellants' submission that a CE mark should be determinative across Member States; it affirmed that national authorities and courts retain competence to decide whether a product falls within the Cosmetics Directive and to apply its restrictions. The proper approach is to interpret the Cosmetics Directive's definition of cosmetic product disjunctively (contact with teeth or mucous membranes suffices) and to focus on intended purpose; Opalescence was intended mainly to change the appearance of teeth and therefore fell within the Cosmetics Directive. Because the Court considered the legal questions sufficiently clear, it declined to refer questions to the European Court of Justice under Article 234 of the Treaty. The appeal was dismissed.

Appeal dismissed. The House of Lords held that the Medical Devices Directive does not apply to cosmetic products covered by the Cosmetics Directive (Article 1(5)(d) MDD). National authorities and courts may determine that a product is a cosmetic product and apply the Cosmetics Directive even if the product bears a CE mark under the MDD. Applying the Cosmetics Directive, Opalescence was a cosmetic product whose marketing could lawfully be restricted by the United Kingdom.