ABSTRACT
The Medical Devices Directive (MDD) (93/42/EEC) (EC93a) is by far the most wide-ranging of the three medical device Directives, and represents the most comprehensive regulation of medical devices ever seen in Europe. Because of the interest it has aroused, the extent to which it is being adopted by other administrations, and the author’s belief that it represents a model for a global system for medical devices, it is described here in considerable detail.
Basic structure of the Directive
