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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Detalhes bibliográficos
Principais autores: 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
Formato: Artigo
Idioma:English
Publicado em: Wiley 2025-03-01
coleção:Bioengineering & Translational Medicine
Assuntos:
Acesso em linha:https://doi.org/10.1002/btm2.10721