THE EUROPEAN MANAGING DIRECTOR AND THE CHALLENGE OF THE SINGLE EUROPEAN MARKET

Any number of factors will affect the profitability and survivability of companies marketing medical devices in Europe in the coming years. Some factors include changing market demands, increasing competition, public procurement and reimbursement practices, and the regulatory factor. The importance of the last, however, continues to elude some European managing directors. In the near future, their companies' medical devices will be the subject of significant new requirements. Managing directors with foresight will begin now to plan for the impending regulations. If they fail to do so and wait until the last minute, they risk increased costs of last-minute compliance, inadequate or incomplete conformity with the regulations, and also loss of competitive edge. This article will examine some of the issues surrounding the readiness of European managing directors to meet forthcoming regulatory challenges in the medical device sector.