This chapter addresses the regulation of medical devices in the European Union. The overall goals of the European regulatory framework for medical devices are the same as the goals of the framework for medicines. It aims to protect public health by ensuring that medical devices are of good quality and safe for their intended use. However, the regulation of medical devices in Europe is very different from the regulation of medicines in two regards. First, unlike medicines, there is no pre-market authorisation by a regulatory authority for medical devices to lawfully enter the EU market. Second, unlike in the United States where the Food and Drug Administration is the primary regulator of devices throughout the nation, the European Union does not have a single regulator of medical devices. Instead, several organisations may be involved, and mainly a notified body in specific cases. The chapter then explains what constitutes a medical device in the EU and how devices are classified according to their level of risk in the EU. It then discusses how medical devices reach the market, how their risks are managed all along their lifecycle, and what kinds of incentives are provided for innovation and competition. The chapter also analyses the balance between public and private actors in the regulation of medical devices. It then concludes with case studies of innovative medical technologies that have challenged the traditional European regulatory scheme and that have led to many revisions in the 2017 device regulations.
The new European regulatory framework for medical devices: opportunities for engagement by electrophysiologists†
