BIOLOGICAL ASSESSMENT OF DENTAL MATERIALS IN EUROPE 1993 - RECOMMENDATIONS AND REGULATIONS

The requirements for biological testing in Europe have evolved over th e last 30 years. A milestone was passed when the EEC Directive concern ing Medical Devices was published on 1 February, 1993. It included the essential requirements for medical devices used in dentistry. Many ad ministrative problems have to be resolved in the following two years u ntil 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.