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.

Part of the controversy surrounding competition and health care stems from the complexity connected with delineating the applicability of competition law – encompassing both the provisions governing anticompetitive agreements and abuse of dominance and the state-aid rules. Cases determined at the European Union (EU) level within the past 30 years have developed a broad framework, and notable trends have emerged – for example, a distinction between health care providers and managing bodies (purchasers). The former have been subject to an ‘abstract’ test and the latter to a more sophisticated ‘concrete’ test. In this paper, we chart the development of the EU courts’ approach to developing the ‘undertaking’ concept in health care and examine the current EU competition law framework with a view to identifying future directions. van de Gronden has recently identified a ‘three-prong’ test of exemption from competition law in connection with the recent CEPPB case: firstly, where the supply of services is predominantly dependent upon public financing; secondly, the public funding aims to achieve a public interest goal and thirdly, the activities concerned are closely related to this public interest goal. We examine this test in a health care context, drawing on our findings regarding Dutch competition reforms.