A new platform for post-marketing surveillance and real-world evidence data collection for substance-based medical devices

The recent passage of European Union (EU) Regulation 2017/745 on medical devices (MDs) has improved the classification of MDs and revised their approval process and the post-marketing evaluation of their safety and effectiveness, promoting transparency and post-marketing oversight in Europe. This ne...

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Principais autores:	Roberto Cioeta, Andrea Cossu, Emiliano Giovagnoni, Marta Rigoni, Paola Muti
Format:	Artigo
Jezik:	Inglês
Izdano:	Frontiers Media S.A. 2022-12-01
Serija:	Frontiers in Drug Safety and Regulation
Teme:	EU Regulation 2017/745 substance-based medical devices post-market surveillance benefit–risk ratio real-world data online platform
Online dostop:	https://www.frontiersin.org/articles/10.3389/fdsfr.2022.992359/full
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