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The European Medical Device Regulation–What Biomedical Engineers Need to Know
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...
Formato: | Online Artículo Texto |
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Lenguaje: | English |
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IEEE
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9395138/ https://www.ncbi.nlm.nih.gov/pubmed/36003070 http://dx.doi.org/10.1109/JTEHM.2022.3194415 |
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collection | PubMed |
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. |
format | Online Article Text |
id | pubmed-9395138 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | IEEE |
record_format | MEDLINE/PubMed |
spelling | pubmed-93951382022-08-23 The European Medical Device Regulation–What Biomedical Engineers Need to Know IEEE J Transl Eng Health Med Article 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. IEEE 2022-07-28 /pmc/articles/PMC9395138/ /pubmed/36003070 http://dx.doi.org/10.1109/JTEHM.2022.3194415 Text en https://creativecommons.org/licenses/by/4.0/This work is licensed under a Creative Commons Attribution 4.0 License. For more information, see https://creativecommons.org/licenses/by/4.0/ |
spellingShingle | Article The European Medical Device Regulation–What Biomedical Engineers Need to Know |
title | The European Medical Device Regulation–What Biomedical Engineers Need to Know |
title_full | The European Medical Device Regulation–What Biomedical Engineers Need to Know |
title_fullStr | The European Medical Device Regulation–What Biomedical Engineers Need to Know |
title_full_unstemmed | The European Medical Device Regulation–What Biomedical Engineers Need to Know |
title_short | The European Medical Device Regulation–What Biomedical Engineers Need to Know |
title_sort | european medical device regulation–what biomedical engineers need to know |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9395138/ https://www.ncbi.nlm.nih.gov/pubmed/36003070 http://dx.doi.org/10.1109/JTEHM.2022.3194415 |
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