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

• Main Authors: Marisa Meloni (Author), Barbara De Servi (Author), Francesco Carriero (Author), Emmanuelle Simon O'Brien (Author), Dounia Houamel (Author), Philippe Deruelle (Author), Vincent Castagné (Author)
• Format: Book
• Published: Frontiers Media S.A., 2024-09-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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 "...