Femasys announces initiation of post-market surveillance study for FemBloc

Femasys (FEMY) announced the commencement of a post-market surveillance, PMS, clinical study for its CE-marked FemBloc Permanent Birth Control. This study is being conducted in accordance with the European Union Medical Device Regulation, EU MDR, and numerous thought leaders throughout the region. This PMS study is a key component of Femasys’ long-term commitment to monitor the safety and performance of its products in real-world settings while complying with the rigorous post-market requirements introduced under the MDR framework. The study has received approval from multiple Ethics Committees and is being carried out in compliance with ISO 14155:2020 for Good Clinical Practice and applicable national regulations.