Biological assessment of dental materials in Europe 1993--recommendations and regulations.

The requirements for biological testing in Europe have evolved over the last 30 years. A milestone was passed when the EEC Directive concerning Medical Devices was published on 1 February, 1993. It included the essential requirements for medical devices used in dentistry. Many administrative problems have to be resolved in the following two years until the requirements outlined become mandatory. The certification of medical devices used in dentistry will be based on European standards which are identical or similar to international (ISO) standards.