March 9, 2021
Eitan Medical notes their Sapphire infusion system, the pump, accessories, and administration sets, have received EU Medical Device Regulation (MDR) 2017/45 certification. The approval was granted in January 2021.
“This is an important milestone for Eitan Medical, representing our commitment to meeting the most stringent regulatory requirements. We prioritized securing MDR clearance early this year, in order to meet the most stringent up to date standards continually enhancing quality for our customers.” said Judith Antler, Executive Vice President of Quality Assurance and Regulatory Affairs at Eitan Medical. “The sophisticated design of the Sapphire and its accessories enabled us to complete the processes required to meet MDR’s updated safety standards.”
Eitan Medical’s Sapphire™ infusion system serves clinicians in hospitals and home care environments across Europe. The Sapphire’s upgraded software Rev15, certified by EU MDR, delivers a simplified workflow, increasing its ease of use. Additionally, the upgraded Sapphire system offers a new fleet configuration management tool, newly developed administration sets, preset programs, and the FasTest PM preventative maintenance solution, designed for fast and efficient on-site fleet management.
“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,” said Chief Commercial Officer of Medication Delivery Solutions at Eitan Medical, Roger Massengale. “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.”
MDR is an expansion of European medical device regulations that emphasizes transparency, patient safety, and post-market surveillance. Following May 2021, medical devices, including infusion pumps, accessories, and administration sets, that are not MDR approved, can continue to be sold until 2024, after which they must be removed from the market. Other news here.