Scoping review on regulation, implementation and postmarket surveillance of medical devices
Mathias Damkjær, Mia Elkjær, Asbjørn Hróbjartsson, Jeppe B. Schroll
Abstract
Regulation and postmarket surveillance of medical devices have been criticized for being too lenient as compared to drug regulation and postmarket surveillance. Little is known about the factors that determine which medical devices are chosen for implementation among similar medical devices.
Introduction
Medical devices are fundamental to medicine, and the basis for a growing billion-dollar industry [1,2]. The World Health Organization estimates that there are more than two million medical devices on the world market and they range from pacemakers, artificial intelligence software to simple instruments such as scalpels [3].
Methods
The study was preregistered, and the protocol was uploaded to Open Science Framework (https://osf.io/mx36f). The scoping review was conducted following the JBI Methods Manual for Scoping Reviews (JBI manual) [19–21] and reported according to PRISMA-ScR [22] for scoping reviews.
Results
The search identified 4,904 records. After de-duplication, 3,862 title/abstracts were screened and 368 full-text studies were assessed, out of which 141 met eligibility criteria, and 139 were included in the final analysis.
Discussion
We included 139 primary studies on medical device regulation, implementation and postmarket surveillance. Studies revealed that it was difficult for regulatory agencies and health care providers to know what clinical evidence suffice for regulatory approval and subsequent implementation of medical devices.
Conclusion
Studies on medical devices are mainly conducted using FDA device databases, since restricted access to publicly available data has hindered research within the EU. Analyses from studies of regulatory approval applications submitted to the FDA have generally found the evidence supporting medical devices to be of low quality.
Citation: Damkjær M, Elkjær M, Hróbjartsson A, Schroll JB (2025) Scoping review on regulation, implementation and postmarket surveillance of medical devices. PLoS One 20(5): e0325250. https://doi.org/10.1371/journal.pone.0325250
Editor: Swarnali Goswami, Neurocrine Biosciences Inc, UNITED STATES OF AMERICA
Received: October 28, 2024; Accepted: May 9, 2025; Published: May 30, 2025
Copyright: © 2025 Damkjær et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: All relevant data are within the paper and its Supporting information files, and at the Open Science Framework fileserver: https://osf.io/nj3be/files/osfstorage.
Funding: The author(s) received no specific funding for this work.
Competing interests: The authors have declared that no competing interests exist.
