Regulatory developments in the medical devices sector: A long and difficult journey

Abstract

Because the development of medical devices, device users, and the devices themselves often cross borders, medical device regulations in Switzerland are closely aligned with those of the European Union. Therefore, the Regulatory Affairs Watch editorial team wanted to hear first-hand from a European stakeholder who has been involved in this matter since the events that triggered the changes to European medical device regulation. In this first Deep Dive article, Catherine Simonin, MD, who is actively engaged in France’s Ligue contre le cancer (LCC, league against cancer) and the overarching national patient organisation France Assos Santé, discusses some of the drivers of regulatory changes for medical devices. The LCC has long been advocating for medical device legislation to focus more on patient safety, and the effects of its advocacy efforts can be seen in the EU’s changing legislative landscape. Using a Q&A format, Catherine Simonin also presents the perspective of patients and patient organisations on the EU’s recent Medical Device Regulation.