Medical Device Regulation and current challenges for the implementation of new technologies

The European Parliament and the European Council on May 26, 2017 decided to introduce the new regulatory framework for medical devices. The transitional period of the so called Medical Device Regulation (EU 2017/745, MDR) should end on May 26, 2020. Currently the European Commission is working on a...

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Autores principales:	Kaule Sebastian, Bock Andrea, Dierke Ariane, Siewert Stefan, Schmitz Klaus-Peter, Stiehm Michael, Klar Ernst, Leuchter Matthias, Lenarz Thomas, Zygmunt Marek, Schmidt Wolfram, Grabow Niels
Formato:	article
Lenguaje:	EN
Publicado:	De Gruyter 2020
Materias:	medical device regulation ce-certification regulatory affairs Medicine R
Acceso en línea:	https://doaj.org/article/6e80e29241a24717ab6126b0ade16be1
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spelling	oai:doaj.org-article:6e80e29241a24717ab6126b0ade16be12021-12-05T14:10:42ZMedical Device Regulation and current challenges for the implementation of new technologies2364-550410.1515/cdbme-2020-3086https://doaj.org/article/6e80e29241a24717ab6126b0ade16be12020-09-01T00:00:00Zhttps://doi.org/10.1515/cdbme-2020-3086https://doaj.org/toc/2364-5504The European Parliament and the European Council on May 26, 2017 decided to introduce the new regulatory framework for medical devices. The transitional period of the so called Medical Device Regulation (EU 2017/745, MDR) should end on May 26, 2020. Currently the European Commission is working on a proposal to postpone the application for one year to relieve pressure from all stakeholders allowing them to fully focus on priorities related to the coronavirus crisis. From this date or most likely from May 26, 2021, manufacturers must present a CE-certificate according to the new MDR requirements not only for novel medical devices, but also for approved medical devices which are already on the market. The MDR will significantly complicate the process of bringing medical devices into market due to the increased requirements for the CE-certification process, particularly concerning increased documentation effort. This involves a risk for the translation of innovative products due to an overload of the overall system (manufacturers, Notified Bodies, experts) and might lead to shrinkage of the product range of existing products. Thankfully, adaption of transitional periods, special regulations, extensions of deadlines and most probably postponement of the MDR application date will ensure that there will be no gaps in medical supply that endanger patients. Establishing and keeping the relevant regulatory expertise up to date and devoting the necessary financial, time and human resources that is the biggest immediate challenge the medium-sized medical technology sector is facing in the near future. The current article, written about one month before the initially expected end of the first transition period on May 26, 2020, summarized the main aspects of the current state of MDR implementation with respect to regulatory novelties, the current legal basis in Germany, transition periods and changes in the requirements of CE-certification relevant technical documentation. Furthermore, challenges for existing and innovative medical devices were shortly discussed using a new stent based therapy of the proximal Fallopian tubal stenosis and transcatheter aortic valve implantation as two examples.Kaule SebastianBock AndreaDierke ArianeSiewert StefanSchmitz Klaus-PeterStiehm MichaelKlar ErnstLeuchter MatthiasLenarz ThomasZygmunt MarekSchmidt WolframGrabow NielsDe Gruyterarticlemedical device regulationce-certificationregulatory affairsMedicineRENCurrent Directions in Biomedical Engineering, Vol 6, Iss 3, Pp 334-337 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	medical device regulation ce-certification regulatory affairs Medicine R
spellingShingle	medical device regulation ce-certification regulatory affairs Medicine R Kaule Sebastian Bock Andrea Dierke Ariane Siewert Stefan Schmitz Klaus-Peter Stiehm Michael Klar Ernst Leuchter Matthias Lenarz Thomas Zygmunt Marek Schmidt Wolfram Grabow Niels Medical Device Regulation and current challenges for the implementation of new technologies
description	The European Parliament and the European Council on May 26, 2017 decided to introduce the new regulatory framework for medical devices. The transitional period of the so called Medical Device Regulation (EU 2017/745, MDR) should end on May 26, 2020. Currently the European Commission is working on a proposal to postpone the application for one year to relieve pressure from all stakeholders allowing them to fully focus on priorities related to the coronavirus crisis. From this date or most likely from May 26, 2021, manufacturers must present a CE-certificate according to the new MDR requirements not only for novel medical devices, but also for approved medical devices which are already on the market. The MDR will significantly complicate the process of bringing medical devices into market due to the increased requirements for the CE-certification process, particularly concerning increased documentation effort. This involves a risk for the translation of innovative products due to an overload of the overall system (manufacturers, Notified Bodies, experts) and might lead to shrinkage of the product range of existing products. Thankfully, adaption of transitional periods, special regulations, extensions of deadlines and most probably postponement of the MDR application date will ensure that there will be no gaps in medical supply that endanger patients. Establishing and keeping the relevant regulatory expertise up to date and devoting the necessary financial, time and human resources that is the biggest immediate challenge the medium-sized medical technology sector is facing in the near future. The current article, written about one month before the initially expected end of the first transition period on May 26, 2020, summarized the main aspects of the current state of MDR implementation with respect to regulatory novelties, the current legal basis in Germany, transition periods and changes in the requirements of CE-certification relevant technical documentation. Furthermore, challenges for existing and innovative medical devices were shortly discussed using a new stent based therapy of the proximal Fallopian tubal stenosis and transcatheter aortic valve implantation as two examples.
format	article
author	Kaule Sebastian Bock Andrea Dierke Ariane Siewert Stefan Schmitz Klaus-Peter Stiehm Michael Klar Ernst Leuchter Matthias Lenarz Thomas Zygmunt Marek Schmidt Wolfram Grabow Niels
author_facet	Kaule Sebastian Bock Andrea Dierke Ariane Siewert Stefan Schmitz Klaus-Peter Stiehm Michael Klar Ernst Leuchter Matthias Lenarz Thomas Zygmunt Marek Schmidt Wolfram Grabow Niels
author_sort	Kaule Sebastian
title	Medical Device Regulation and current challenges for the implementation of new technologies
title_short	Medical Device Regulation and current challenges for the implementation of new technologies
title_full	Medical Device Regulation and current challenges for the implementation of new technologies
title_fullStr	Medical Device Regulation and current challenges for the implementation of new technologies
title_full_unstemmed	Medical Device Regulation and current challenges for the implementation of new technologies
title_sort	medical device regulation and current challenges for the implementation of new technologies
publisher	De Gruyter
publishDate	2020
url	https://doaj.org/article/6e80e29241a24717ab6126b0ade16be1
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Medical Device Regulation and current challenges for the implementation of new technologies

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