EU Policymaking on Medical Devices

European Union (EU) policymaking on medical devices represents regulatory policy-making par excellence. There are two novel aspects of regulatory policymaking that merit attention in the EU era. First, the EU-wide regulation of medical devices came about as a result of the political decision to launch the single European market project. Second, EU policymaking on medical devices is closely connected to global regulatory activities. EU member states' autonomy over health protection and the organization of the delivery system is being challenged by the dynamic economic spillovers and little publicized rulings by the European Court of Justice (ECJ) and an increasing body of pertinent case law. In some EU countries in the 1990s, payers imposed restrictive measures to stem rising health-care costs. For example, payers in France and the UK limited access to innovative treatments or procedures and Germany introduced similar measures.