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

• मुख्य लेखकों: Marisa Meloni (लेखक), Barbara De Servi (लेखक), Francesco Carriero (लेखक), Emmanuelle Simon O'Brien (लेखक), Dounia Houamel (लेखक), Philippe Deruelle (लेखक), Vincent Castagné (लेखक)
• स्वरूप: पुस्तक
• प्रकाशित: Frontiers Media S.A., 2024-09-01T00:00:00Z.
• विषय: article
• ऑनलाइन पहुंच: 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 "...