Eitan Medical, Netanya, Israel, announced 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,” says 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.
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.