Biomedical company Femasys has obtained the EU Medical Device Regulation (EU MDR) certificate and CE Mark certification for four women’s health products.
Now in compliance with the new EU legislation for medical devices, the products – FemaSeed, FemVue, FemCerv and FemCath – are developed for women’s reproductive health.
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The latest development paves the way for the company to commence commercialisation efforts for the products within the European market.
The CE Mark approval for these four products follows closely after the company received the MDR certification.
Femasys’ regulatory team, in collaboration with TÜV SÜD, successfully completed the MDR application process to gain this certification.
Femasys founder, president and CEO Kathy Lee-Sepsick said: “The CE Mark, which follows MDR certification, provides regulatory approval for us to begin marketing four of our products in the European Union. Further, it serves as independent validation of Femasys’ commitment to the highest standards of quality and safety for our customers and their patients.
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By GlobalData“We recently completed the build-out of our initial commercial team in the US, the focus of our primary marketing efforts. Upon receiving CE Mark approval for our portfolio of products, we can now concurrently identify strategic distribution partners to commercialise our products throughout the European Union.”
In January this year, Femasys announced that its pivotal FINALE trial for the FemBloc permanent birth control device was progressing well, with the recruitment of participants ongoing.
The University of Utah Hospital in the US was added as a new recruitment site, joining other medical centres and universities across four US states in the trial.
