EDI System Definition for a European Medical Device Vigilance System G. Doukidis 1 , N. Pallikarakis 2 , G. Pangalos 3 , G. Vassilacopoulos 4 , K. Pramataris 1 1 Dept. of Informatics, Athens University of Economics and Business, Greece 2 Institute of Biomedical Technology (INBIT), Patras, Greece 3 Informatics Lab., Faculty of Technology, Aristotle University of Thessaloniki, Greece 4 Dept. of Informatics, University of Piraeus, Greece Abstract. 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 more specifically its application to the Medical Device Vigilance System. At a first place, 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. Keywords: medical device vigilance, EDI 1. Introduction The Medical Device Vigilance System (MDVS) is a Europe-wide system that has been created in response to the requirements imposed by the Active Implantable Medical Devices (AIMD) and the Medical Devices (MD) directives of the European Commission. The system has three main objectives [1]: • to protect reoccurrence of incidents with the same type of medical device, at another place, at another time; • to encourage manufacturers to perform investigations and take corrective actions if necessary; • to enable competent authorities to monitor the investigation procedures and intervene when necessary. To achieve these objectives, a considerable amount of regulatory data needs to be stored and communicated among the parties involved in the investigation and reporting process regarding medical devices. These parties are: competent authorities (e.g. government agencies), notified bodies (e.g. standardisation organizations), manufacturers and/or their authorized representatives, users of the medical devices (e.g. hospitals), and the European Commission. This need of communication and information exchange has given rise to the European Medical Device Information Exchange System (EUROMEDIES) concerted action project [2]. The main objective of this project was to investigate the requirements for a telematics-based system with respect both to database applications for storing regulatory data and incident reports, pertaining to the medical devices, and to the network services for the exchange of the required information among the involved parties. This action is intended to promote a harmonized approach for different initiatives, to be undertaken by concerned parties in different countries, in order to face the MD requirements [3]. 1