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February 1, 2003

Legal Re-classification of Breast Implants as a Medical Device in The European Union

Arnold & Porter Advisory

Breast implants are regulated as medical devices in the European Union under Council Directive 93/42/EEC as amended by Directives 98/79/EC and 2000/70. The Directive contains the essential requirements, in terms of quality and safety, that medical devices such as breast implants must meet in order to ensure a high level of protection of consumer health. There are also specific obligations imposed on the manufacturer of the device with regard to labelling and information provided to the patient and the physician.