This marks a step forward as the San Diego-based company looks to bring its insulin pump technology to Europe. Unlike in the U.S., European clearance requires audit steps driven by a third party known as the notified body. BSI Group will be the notified body for Modular Medical’s CE mark process, determining safety and efficacy of the device.
The company believes it can obtain CE mark in the first quarter of 2026.
Modular Medical develops patented insulin delivery technologies, aiming to improve access to glycemic control. Its founder, Paul DiPerna, previously founded leading insulin pump maker Tandem Diabetes Care. DiPerna invented and designed Tandem’s t:slim pump.
Modular Medical designed the 90-day MODD1 with new microfluidics technology to allow for the low-cost pumping of insulin. Its new intuitive design makes the product simple to use and easier to prescribe.
The pump has a reservoir size of 300 units/3mL. Users can monitor the pump activity with their cell phone and do not require an external controller. The pump uses a provided, single-use, disposable battery.
Modular Medical earned FDA clearance for MODD1 in September 2024.
“The MODD1 insulin pump is an ideal fit for the European marketplace,” said Jeb Besser, Modular Medical CEO. “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.”
