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EDI is expected to be the dominant form of business communication between organizations moving to the Electronic Commerce era of 2000. The healthcare sector is already using EDI in the hospital supply function as well as in the clinical area and the reimbursement process. In this paper, we examine the use of EDI in the healthcare administration sector and more specifically its application to the Medical Device Vigilance System. Firstly, the potential of this approach is examined, followed by the definition of the EDI System Reference Model and the specification of the required system architecture. Each of the architecture's components are then explained in more detail, followed by the most important implementation options relating to them.