Laboratory-Developed Tests: Design of a Regulatory Strategy in Compliance with the International State-of-the-Art and the Regulation (EU) 2017/746 (EU IVDR [In Vitro Diagnostic Medical Device Regulation])

PURPOSE: This study aimed at the development of a regulatory strategy for compliance of laboratory-developed tests (LDTs) with requirements of the Regulation (EU) 2017/746 (“EU-IVDR”) under consideration of international requirements for LDTs as established in major regulatory regions. Furthermore,...

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Detalles Bibliográficos
Publicado en:Ther Innov Regul Sci
Autores principales: Spitzenberger, Folker, Patel, Jaimin, Gebuhr, Inga, Kruttwig, Klaus, Safi, Abdulrahim, Meisel, Christian
Formato: Artigo
Lenguaje:Inglês
Publicado: Springer International Publishing 2021
Materias:
Original Research
Acceso en línea:https://ncbi.nlm.nih.gov/pmc/articles/PMC8294224/
https://ncbi.nlm.nih.gov/pubmed/34291407
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s43441-021-00323-7
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