Femasys Inc. EU MDR Final Audit Successfully Completed

– Completion of the European Union Medical Device Regulation (MDR) final audit is the last step in obtaining an MDR certificate and CE marking, confirming Femasys’ compliance with the highest required regulatory standards –

– Femasys continues to fulfill its commitment to bring innovative solutions to women around the world –

ATLANTA, Oct. 26, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative diagnostic products, today 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 has worked diligently to implement the requirements of the EU MDR and completion of the final audit with zero nonconformances and no findings demonstrates Femasys has successfully met the new regulations and can soon supply our products to the European Union market,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “We look forward to continuing to bring our much-needed innovative technologies to women."

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.