Cerus Corporation Advances INTERCEPT RBC CE Mark Submission with Successful Completion of Clinical Module Review by TÜV-SÜD
Reuters
Jul 02
<a href="https://laohu8.com/S/CERS">Cerus Corporation</a> Advances INTERCEPT RBC CE Mark Submission with Successful Completion of Clinical Module Review by TÜV-SÜD
Cerus Corporation (Nasdaq: CERS) has announced progress in the European regulatory process for its INTERCEPT Red Blood Cell $(RBC)$ program. TÜV-SÜD, the company's Notified Body, has successfully completed the review of the clinical module, which included positive results from the U.S. Phase 3 ReCePI clinical trial. This marks a crucial step in Cerus' enhanced CE Mark submission, which aims to cover all patient indications for RBC transfusion. The State Institute for Drug Control (SÚKL) in the Czech Republic will now review the active pharmaceutical ingredient $(API)$ module. Following this, the submission will return to TÜV-SÜD for manufacturing facility audits and certification, as required under the European Medical Device Regulation $(MDR.AU)$ for Class III devices.
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