ABSTRACT
Medical devices are the bread and butter of which health care and clinical research are made. In Europe, medical devices are under-researched areas and their contributions to people's health and well-being hugely underestimated when compared to prescription drugs. The medical device industry was drawn into the dynamics of European integration and changing government-industry relations with the creation of the single European market in the mid-1980s. While public health and health-care policy are powers of the member states, European Union (EU) institutions have jurisdiction over trade, competition, and international competitiveness. Research into the intricacies of EU medical device regulation began in the early 1990s with a general study of EU regulatory policy and global harmonization and interviews were conducted in France, Germany, and the UK in 1994. The work of the scholars on the French bureaucracy is authoritative and allows for situating domestic coordination of EU policy in an established framework.
