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

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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Bibliographic Details
Main Authors: 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
Format: Article
Language:English
Published: De Gruyter 2020-09-01
Series:Current Directions in Biomedical Engineering
Subjects:
medical device regulation
ce-certification
regulatory affairs
Online Access:https://doi.org/10.1515/cdbme-2020-3086

Internet

https://doi.org/10.1515/cdbme-2020-3086

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