The European Medical Device Regulation-What Biomedical Engineers Need to Know.

Melvin, Tom

dc.contributor.author	Melvin, Tom
dc.date.accessioned	2024-05-31T15:28:28Z
dc.date.available	2024-05-31T15:28:28Z
dc.date.issued	2022-07-28
dc.identifier.pmid	36003070
dc.identifier.doi	10.1109/JTEHM.2022.3194415
dc.identifier.uri	http://hdl.handle.net/10147/641730
dc.description	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 medical devices. This includes changes relating to devices produced in healthcare institutions, custom-made devices, single use devices, devices without an intended medical purpose, clinical investigations and device traceability. There are also challenges in implementation of the MDR, with a shortage of available notified bodies needed to conduct conformity assessment, with a consequent risk of product unavailability. Understanding these changes is important as implementing new requirements in practice may require additional resources or the introduction of new processes or systems.	en_US
dc.language.iso	en	en_US
dc.rights	Attribution 4.0 International	*
dc.rights.uri	http://creativecommons.org/licenses/by/4.0/	*
dc.subject	Medical device	en_US
dc.subject	REGULATION	en_US
dc.title	The European Medical Device Regulation-What Biomedical Engineers Need to Know.	en_US
dc.type	Article	en_US
dc.identifier.eissn	2168-2372
dc.identifier.journal	IEEE journal of translational engineering in health and medicine	en_US
dc.source.journaltitle	IEEE journal of translational engineering in health and medicine
dc.source.volume	10
dc.source.beginpage	4800105
dc.source.endpage
refterms.dateFOA	2024-05-31T15:28:30Z
dc.source.country	United States