Modular Medical announces BSI Group as ‘Trusted Body’ for CE mark clearance

Modular Medical (MODD) announced that BSI Group will serve as the notified body for the European regulatory clearance process…”The MODD1 insulin pump is an ideal fit for the European marketplace,” stated Jeb Besser, CEO of Modular Medical. “With U.S. clearance in hand, we are focusing our regulatory efforts on the opportunity in the E.U. In Europe, pump penetration has been challenged with its high cost, considerable environmental impact and complexity of use. We believe that our combination of simplicity to learn and use and the low cost of our device, combined with its lower carbon footprint, reusable electronics and attractive form factor for the patient, will motivate more multiple daily injectors to adopt pumping.”