The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study

The European Union Medical Device Regulations 2017/745 entered into force on May 2021 with changes related to strengthening the clinical evaluation requirements, particularly for high-risk devices. This study investigates how the increased requirements on medical device manufacturers in relation to...

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Detalles Bibliográficos
Autores principales: Kearney, Breda, McDermott, Olivia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10276779/
https://www.ncbi.nlm.nih.gov/pubmed/37198369
http://dx.doi.org/10.1007/s43441-023-00527-z

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10276779/
https://www.ncbi.nlm.nih.gov/pubmed/37198369
http://dx.doi.org/10.1007/s43441-023-00527-z

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