The Medical Device Regulation (MDR) aims to strengthen the EU internal market and increase patient safety.

Initial reactions of scholars, physicians, and industry diverge strongly.

We analyze the main stakeholders and processes set out in the MDR.

The regulation introduces multiple regulatory instruments that are likely to enhance trade.

It will ensure collection of empirical data on patient safety and its systematic analysis.

Following a series of major scandals over the past two decades, the medical device industry is now undergoing a major regulatory change: the implementation of the European Union Medical Device Regulation (MDR) of 2017. After a transitional period of four years, the MDR became fully binding in May 2021. Although the medium- and long-term impacts of the MDR are still unclear, a range of scholars, health care professionals, and industry representatives have begun to publish early evidence and publicize their views on how the new regulation may impact free trade and patient safety. Even a cursory view of their output reveals hypotheses and opinions that could hardly be more divergent. The reasons for this disagreement are unclear and may extend beyond the different interests of the various stakeholder groups. To find out why this might be the case, we examine the MDR and seek to improve scholarly understanding of this most extensive regulation of medical devices since the early 1990s. We offer policymakers suggestions to help them improve future regulation. Based on theoretical considerations, we conclude that while the MDR is highly likely to strengthen the internal market of the EU, its impact on patient safety will remain unclear as long as there are no comprehensive studies on this topic that are based on empirical data.

Public health

Clinical evidence

Transparency

Market entry

Competition

© 2022 Published by Elsevier B.V.