Recent regulatory developments in EU Medical Device Regulation and their impact on biomaterials translation

Abstract We envision this work to assist researchers and medical device developers (beside other stakeholders) to better understand biomaterial‐based medical device development and its approval process proposed by the new MDR and IVDR in the European Union, as more complex biomaterials emerge, with...

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Bibliographic Details

Published in:	Bioengineering & Translational Medicine
Main Authors:	Klaudia M. Jurczak, Torben A. B. van derBoon, Raul Devia‐Rodriguez, Richte C. L. Schuurmann, Jelmer Sjollema, Lidia vanHuizen, Jean‐Paul P. M. De Vries, Patrick vanRijn
Format:	Article
Language:	English
Published:	Wiley 2025-03-01
Subjects:	biomaterials biomaterials clinical translation In Vitro Diagnostic Regulation Medical Device Regulation medical devices
Online Access:	https://doi.org/10.1002/btm2.10721