ABSTRACT
The European Community’s program on the Completion of the Internal Market has, as the primary objective for medical devices, to assure Community-wide free circulation of products. The Active Implantable Medical Devices Directive adopted by the Community legislator in 1990 and the Medical Devices Directive in 1993 cover more than 80% of medical devices for use with human beings. The major legal responsibility the Directives place on the manufacturer of a medical device requires the device meet the Essential Requirements set out in Annex I of the Directive which applies to them, taking into account the intended purpose of the device. It is necessary for the manufacturer of a Medical Device to have some degree of proof that a device complies with the Essential Requirements before the CE marking can be applied. Type testing of many kinds of medical devices, particularly electromedical equipment, is required under some national regulations.
