EDI is expected to be the dominant form of business communication between organisations 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 move specifically its application to the Medical Devices Vigilance System. At a first place, the potential of this approach is examined, after an initial brief presentation of the EDI concept and its application in healthcare. This presentation is followed by an overall description of the EDI prototype system, which was developed in the context of the EUROMEDIES Concerted Action, in order to facilitate the requirements definition phase.