EU Medical Devices Standards

Meeting the Most Stringent EU Medical Devices Standards

The INTERCEPT^TM Blood System has received CE Mark certification as a Class III medical device. As part of the regulatory and certification process, all supporting data and claims are reviewed and approved by TÜV SÜD (Cerus’ notified body) before they are issued.

When claims are made on the INTERCEPT Blood System, you can be sure they have been validated by the appropriate government agencies and authorities:

• CE Mark certified as a Class III medical device
• Approved as alternative to gamma irradiation to prevent TA-GVHD (Available upon request)
• Approved as replacement for CMV serology testing (Available upon request)

Meeting the most stringent EU medical standards for the INTERCEPT Blood System has also led to successful approvals by leading regulatory agencies throughout the world.