The European Medical Device Regulation–What Biomedical Engineers Need to Know [PDF]
IEEE Journal of Translational Engineering in Health and Medicine, 2022 The Medical Device Regulation (EU) 745/2017 (MDR) has replaced the medical device directives which were in place since the early 1990s. MDR introduces a number of changes of relevance to biomedical engineers who work in healthcare institutions or with ...
Tom Melvin
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Medical device regulation (MDR) from a dental perspective [PDF]
Frontiers in Dental Medicine, 2023 A new regulation for the marketing and application of medical devices has become applicable in the European Union as of May 2021. This regulation is termed EU 2017/745 or Medical Device Regulation (MDR). Initially published and entered into force in 2017,
Dirk Mohn, Matthias Zehnder
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Will the EU Medical Device Regulation help to improve the safety and performance of medical AI devices? [PDF]
Digital Health, 2022 Concerns have been raised over the quality of evidence on the performance of medical artificial intelligence devices, including devices that are already on the market in the USA and Europe.
Emilia Niemiec
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Medical device regulation and oversight in African countries: a scoping review of literature and development of a conceptual framework [PDF]
BMJ Global Health, 2023 Regulatory and other governance arrangements influence the introduction of medical devices into health systems and are essential for ensuring their effective and safe use.
Sassy Molyneux +4 more
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How does medical device regulation perform in the United States and the European union? A systematic review. [PDF]
PLoS Medicine, 2012 BackgroundPolicymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems.
Daniel B Kramer +2 more
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Rethinking medical device regulation. [PDF]
J R Soc Med, 2012 Complications with Poly Implant Prosthese (PIP) breast implants1 and Metal on Metal (MoM) hip implants2 reflect systemic failings with the current regulation of medical devices. Yet, these two cases highlight only a fraction of the burgeoning increase in medical device safety alerts3 and problems with device recalls, and are leading to a rethink of the
Heneghan C, Thompson M.
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JMIR Medical InformaticsIn light of rapid technological advancements, the health care sector is undergoing significant transformation with the continuous emergence of novel digital solutions. Consequently, regulatory frameworks must continuously adapt to ensure their
Liga Svempe
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Recent regulatory developments in EU Medical Device Regulation and their impact on biomaterials translation [PDF]
Bioengineering & Translational MedicineWe envision this work to assist researchers and medical device developers (beside other stakeholders) to better understand biomaterial‐based medical device development and its approval process proposed by the new MDR and IVDR in the European Union, as ...
Klaudia M. Jurczak +7 more
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The Medical Device Regulation and its impact on device development and research in Germany [PDF]
Zeitschrift für Medizinische Physik, 2023 Mark E. Ladd
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Balancing innovation and medical device regulation: the case of modern metal-on-metal hip replacements [PDF]
Medical Devices: Evidence and Research, 2016 Jason J Howard1,2 1Division of Orthopedic Surgery, Department of Surgery, Sidra Medical and Research Center, 2Department of Orthopedic Surgery, Weill Cornell Medical College, Doha, Qatar Abstract: Due to problems with wear particle generation and ...
Howard JJ
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