Eitan Medical announced that it received European Union Medical Device Recognition (MDR) certification for its Sapphire infusion pump.
Approval for the Sapphire infusion pump, along with its accessories and administration sets, was granted in January 2021, according to a news release. The certification is EU MDR 2017/45.
Sapphire includes upgraded Rev15 software, also EU MDR certified, to deliver a simplified workflow along with a new fleet configuration management tool, newly developed administration sets, preset programs and a preventative maintenance solution for on-site fleet management.
Eitan Medical EVP of quality assurance & regulatory affairs Judith Antler said in the release that the company prioritized securing MDR clearance earlier this year, with the “sophisticated design” of Sapphire and its accessories enabling the company to meet MDR’s updated safety standards.
“For over a decade, Eitan Medical has developed innovative, future-ready infusion solutions. Receiving MDR clearance was a critical priority for us to ensure that we continue to serve as a reliable partner to our Sapphire™ customers in hospitals, alternate site, homecare and pre-hospital settings,” Eitan Medical chief commercial officer of medication delivery solutions Roger Massengale said in the release. “Achieving MDR clearance was not only necessary from a regulatory perspective, but demonstrates again, the safety of our products. Clinicians can rest assured that they are delivering optimal care to their patients with our infusion solutions.”