Eitan Medical Receives EU MDR Clearance for Sapphire™ Infusion System

Sapphire™ achieves regulatory milestone

Netanya, Israel – March 09, 2021 – Eitan Medical, a global leader in advanced infusion therapy and
drug delivery devices across the care continuum, announced today that its Sapphire™ infusion
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.

About Eitan Medical

Eitan Medical is reimagining drug delivery, with reliable innovations that put patients at the center of care, making drug delivery easier and safer than ever before.

Patient safety and care are only the starting point, as Eitan Medical goes beyond- delivering connected, intuitive drug delivery and infusion solutions that are designed to improve patient and clinician quality of life across the continuum of care, including hospital, ambulatory, and home care environments. For over a decade, Eitan Medical has provided safe, intuitive, and flexible solutions that meet evolving drug delivery needs. Eitan Medical’s product lines include the SapphireTM infusion platform*, providing connected infusion therapy systems in hospital and ambulatory settings; the SorrelTM wearable drug delivery platform**, the patient-centric on-body injector for delivery of biologic treatments; and AvosetTM, connected infusion systems for the home care market.

For more information, visit: https://eitanmedical.com/.
* Q Core Medical Ltd is legal manufacturer of the SapphireTM infusion pump.
**Sorrel Medical Ltd is legal manufacturer of the SorrelTM wearable drug delivery platform (FDA investigational device).
***The AvosetTM devices are under development.
Eitan Medical, Sapphire, Avoset, and Sorrel are trademarks or registered trademarks of Eitan Medical.

EU MDR certificate