Demonstrating the principal mechanism of action of medical devices intended for vaginal use on reconstructed human vaginal epithelium: the case of two hyaluronic acid-containing devices

Demonstrating the principal mechanism of action of medical devices intended for vaginal use on reconstructed human vaginal epithelium: the case of two hyaluronic acid-containing devices

Regulation (EU) 2017/745 on medical devices (MDR) has significantly modified the rules to be adopted for MD qualifications and classification. New requirements require robust evidence on mechanisms of action (MoAs) that cannot be produced by existing common EU or ISO standards. Therefore, on a “case...

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Bibliographic Details
Main Authors: Marisa Meloni, Barbara De Servi, Francesco Carriero, Emmanuelle Simon O’Brien, Dounia Houamel, Philippe Deruelle, Vincent Castagné
Format: Article
Language:English
Published: Frontiers Media S.A. 2024-09-01
Series:Frontiers in Drug Safety and Regulation
Subjects:
film forming
medical device regulation
3D human tissues
re-epithelization
vaginal dryness
Online Access:https://www.frontiersin.org/articles/10.3389/fdsfr.2024.1445519/full
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https://www.frontiersin.org/articles/10.3389/fdsfr.2024.1445519/full

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