of users, who, when the devices initially arrive at the place of intended use, struggle with an important task of correctly identifying and registering these devices in their local databases. This means that there are a number of players, having quite different responsibilities and levels of understanding of the processes, but all with one common interest, that of ensuring the availability of sound medical devices to the general public. To assist in this very important process there is a need for a common method INTRODUCTION Within all regulations concerned with medical devices, there are a number of obligations placed upon the manufacturer. In addition, the authorities are faced with the task of regulating the manufacturers and their devices, and there are the people involved in the trade of these devices (e.g., the suppliers), before the devices themselves are brought into use. Finally, of course, there is the myriad

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devices have extended the ability of physicians to diagnose and treat diseases, making great contributions to health and quality of life, and without any doubt, these technologies have changed the mainstream practice of medicine. The intended primary mode of action of a medical device on INTRODUCTION The term 'Medical Devices' includes everything from highly sophisticated, computerized, medical equipment, right down to simple wooden tongue depressors. Medical

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