The regulation of medical devices, particularly those that are implantable or high-risk, has received much attention in the lay media of late. Most recently, the release of analyses from a collaboration of international journalists in November 2018 made front-page news around the world. In many countries, authorities and physicians seemed to be caught on the wrong foot and put in a position of reaction rather than action. However, in Europe, reform of the medical device regulatory processes has been ongoing for a number of years. As cardiology devices are among the most frequent high-risk devices in clinical use, our community is affected more than other specialties. Indeed, among professional societies, the European Society of Cardiology has taken the lead in advocating for improved regulation for much of the last decade1,2.
Medical devices have been regulated in a coordinated fashion throughout Europe since the 1990s. At that time, the first Europe-wide medical device directives (MDD) were published in 1990 and 19933,4. Over the past decade, a number of scandals emerged regarding patients harmed as a result of treatment with approved medical devices. These included the Poly Implant Prothèse (PIP) breast implant scandal, controversy with regard to metal on metal hip replacements, and complications after vaginal mesh implantation. Although the PIP breast implant scandal appeared to be more a case of fraud than a failure of approval processes, the notified body responsible for the conformity assessment of the product was found liable for damages due to failures in monitoring of the manufacturer5.
At the same time, the first steps were taken to overhaul device regulatory processes in Europe in the realisation that the MDD had become outdated. The overall goal of the initiative is to improve the clinical safety of medical devices on the market in Europe and to increase the credibility and reputation of the oversight system. These processes culminated in the publication of the new medical device regulation (MDR) in May 20176. In parallel, a separate regulation was published dealing with in vitro diagnostics. Regulations, unlike directives, immediately become law in all member states. Currently, we are in the middle of a transition period of three years, which permits devices to be evaluated under either MDD or MDR; this will come to an end in May 2020. After this time point, all medical devices must be approved according to MDR processes. Certificates of devices already on the market – known as legacy devices – will remain valid for a further four years until May 2024.
So what are the new features of the MDR and how can an individual cardiologist contribute to improved patient safety? Moreover, what are the new responsibilities for physicians and hospitals and what are the new opportunities for engagement?