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After the four-year transition period: Is the European Union's Medical Device Regulation of 2017 likely to achieve its main goals?

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  • Shatrov, Kosta
  • Blankart, Carl Rudolf

Abstract

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.

Suggested Citation

  • Shatrov, Kosta & Blankart, Carl Rudolf, 2022. "After the four-year transition period: Is the European Union's Medical Device Regulation of 2017 likely to achieve its main goals?," Health Policy, Elsevier, vol. 126(12), pages 1233-1240.
  • Handle: RePEc:eee:hepoli:v:126:y:2022:i:12:p:1233-1240
    DOI: 10.1016/j.healthpol.2022.09.012
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    References listed on IDEAS

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    1. Stern, Ariel Dora, 2017. "Innovation under regulatory uncertainty: Evidence from medical technology," Journal of Public Economics, Elsevier, vol. 145(C), pages 181-200.
    2. Matthew Grennan & Robert J. Town, 2020. "Regulating Innovation with Uncertain Quality: Information, Risk, and Access in Medical Devices," American Economic Review, American Economic Association, vol. 110(1), pages 120-161, January.
    3. Campillo-Artero, Carlos, 2013. "A full-fledged overhaul is needed for a risk and value-based regulation of medical devices in Europe," Health Policy, Elsevier, vol. 113(1), pages 38-44.
    4. Blankart, Carl Rudolf & Dams, Florian & Penton, Hannah & Kaló, Zoltán & Zemplényi, Antal & Shatrov, Kosta & Iskandar, Rowan & Federici, Carlo, 2021. "Regulatory and HTA early dialogues in medical devices," Health Policy, Elsevier, vol. 125(10), pages 1322-1329.
    5. Zippel, Claus & Bohnet-Joschko, Sabine, 2017. "Post market surveillance in the german medical device sector – current state and future perspectives," Health Policy, Elsevier, vol. 121(8), pages 880-886.
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