Medicine and Public Issues
18 April 2023

The New European Medical Device Regulation: Balancing Innovation and Patient Safety

Publication: Annals of Internal Medicine
Volume 176, Number 6

Abstract

The European Union has introduced stricter provisions for medical devices under the new Medical Device Regulation (MDR). The MDR increases requirements for clinical trial testing for many devices before they can legally be placed on the market and extends requirements for rigorous clinical surveillance of benefits and harms to the entire life cycle of devices. New “expert panels” have been established by the European Commission to advise in the assessment of devices toward certification, and the role of previous “notified bodies” (private companies charged by the Commission with ensuring that manufacturers follow the requirements for device testing) is being expanded. The MDR does not contain a grandfathering clause; thus, all existing medical devices must be recertified under the stricter regulation. The recertification deadline has recently been extended to 2027 or 2028, depending on the device's risk class. Whether most device manufacturers can meet these new requirements is uncertain, and the MDR will likely have important consequences for manufacturers, researchers, clinicians, and patients. Enhanced collaborations between the medical device industry and physician partners will be needed to meet the new requirements in a timely manner to avoid shortages of existing devices and to mitigate barriers to development of new devices.

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Information & Authors

Information

Published In

cover image Annals of Internal Medicine
Annals of Internal Medicine
Volume 176Number 6June 2023
Pages: 844 - 848

History

Published online: 18 April 2023
Published in issue: June 2023

Keywords

Authors

Affiliations

Michael Bretthauer, MD, PhD https://orcid.org/0000-0001-9653-6886
Clinical Effectiveness Research Group, University of Oslo, and Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway, and Institute of Clinical Medicine, University of Tromsø, Tromsø, Norway (M.B.)
Sara Gerke, Dipl-Jur Univ, MA https://orcid.org/0000-0002-5718-3982
Penn State Dickinson Law, Carlisle, Pennsylvania (S.G.)
Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Italy, and Humanitas Clinical and Research Center–IRCCS, Endoscopy Unit, Rozzano, Italy (C.H.)
Omer F. Ahmad, BSc, MD
Wellcome/EPSRC Centre for Interventional & Surgical Sciences, University College London, London, United Kingdom (O.F.A.)
Yuichi Mori, MD, PhD
Clinical Effectiveness Research Group, University of Oslo, and Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway, and Showa University Northern Yokohama Hospital, Digestive Disease Center, Yokohama, Japan (Y.M.).
Disclaimer: The views and opinions expressed in this article are those of the authors only and do not necessarily reflect those of the European Union or the Health and Digital Executive Agency.
Grant Support: All authors were supported by European Union grant no. 101057099. Ms. Gerke was supported by European Union grant no. 101057321.
Corresponding Author: Michael Bretthauer, MD, PhD, University of Oslo, Postbox 1089 Blindern, Oslo, 0318, Norway; e-mail, [email protected].
Author Contributions: Conception and design: M. Bretthauer, S. Gerke, C. Hassan, O.F. Ahmad, Y. Mori.
Analysis and interpretation of the data: M. Bretthauer, C. Hassan, Y. Mori.
Drafting of the article: M. Bretthauer, S. Gerke, O.F. Ahmad, Y. Mori.
Critical revision for important intellectual content: S. Gerke, C. Hassan, O.F. Ahmad, Y. Mori.
Final approval of the article: M. Bretthauer, S. Gerke, C. Hassan, O.F. Ahmad, Y. Mori.
Obtaining of funding: M. Bretthauer, Y. Mori.
Administrative, technical, or logistic support: M. Bretthauer.
Collection and assembly of data: M. Bretthauer, Y. Mori.
This article was published at Annals.org on 18 April 2023.

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Michael Bretthauer, Sara Gerke, Cesare Hassan, et al. The New European Medical Device Regulation: Balancing Innovation and Patient Safety. Ann Intern Med.2023;176:844-848. [Epub 18 April 2023]. doi:10.7326/M23-0454

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