Femasys Inc. announced that it has successfully completed the Stage 2 European Union (EU) Medical Device Regulation (MDR 2017/745) onsite audit resulting in zero nonconformances and no findings. This is the final audit phase in the MDR designation process that was conducted by TUV SUD America Inc., a recognized Auditing Organization and Notified Body. Successful completion of both Stage 1 and Stage 2 MDR audits confirms Femasys is compliant in all areas of MDR and may progress to issuance of the MDR certification, allowing for Femasys?

products to secure CE Marking. Femasys is creating accessible innovative options for women, as exemplified by its lead product candidate, FemBloc in late-stage clinical development for permanent birth control and its United States Food and Drug Administration (FDA)-cleared product, FemaSeed for infertility treatment that is also approved in Canada. The Company is also commercializing complementary diagnostic products, FemVue, FemCath and FemCerv, all of which were internally developed through its in-house R&D and manufacturing capabilities, with regulatory approvals in the U.S., Canada and other ex-U.S. territories.