Neither protective nor harmonized: the crossborder regulation of medical devices in the EU.

Abstract

To what extent does inadequate market regulation contribute to poor health outcomes? A series of prominent scandals involving harmful medical devices has made improving the regulation of these devices an urgent problem for the European Union (EU). This is, however, a specific example of a general phenomenon. The EU remains first and foremost a large and integrated market within which the EU institutions have considerable regulatory authority. Even if there is little EU commitment to a health or social policy agenda, its use of that regulatory authority shapes health care cost and quality and should be understood as health policy. We use data from EU-level and national policy documents to analyse the EU's current regulatory framework for medical devices and assess its likely future efficacy. Despite revising the medical devices directive to require more stringent pre-authorization requirements for high-risk medical devices and improvements in post-market surveillance, the key underlying problems of market fragmentation and patient safety persist. Without strong and consistent support for the implementation of the new directive, the likely result is the status quo, with significant consequences for health in Europe.