Israeli medtech start-up receives European Medical Device Regulation approval

"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 VP says.

Eitan Medical's SapphireTM infusion pump (photo credit: Courtesy)
Eitan Medical's SapphireTM infusion pump
(photo credit: Courtesy)
Israeli medtech company Eitan Medical received EU Medical Device Regulation (MDR) 2017/45 certification for the newest upgrades to its Sapphire™ infusion pump accessories and administration sets, the company announced on Tuesday, two months after receiving FDA approval for its system software Rev15.
The products serve clinicians in hospitals and home care environments across Europe with pain management therapies.
“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," she said.
The Sapphire’s upgraded Rev15 software, certified by EU MDR, delivers a simplified workflow, increasing its ease of use including a perineural route to support a larger range of pain management therapies.
The software was also simplified to reduce key presses, message prompts and preset offerings and includes the FasTest PM preventative maintenance solution, designed for fast and efficient on-site fleet management.
Additionally, the epidural portfolio was updated with NRFit® dedicated connectors.
“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 Roger Massengale, chief commercial officer of Medication Delivery Solutions.

“Achieving MDR clearance was not only necessary from a regulatory perspective, but demonstrates again the safety of our products," he said. "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.