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. Unlike the U.S. process, European Union clearance of a medical device is driven by a series of audit steps driven by a third party, known as a notified body, retained by the sponsor of the device to determine safety and efficacy, and the notified body then certifies that the CE mark standards have been met. Once the CE mark is obtained, a device can be marketed and sold in Europe and other areas that rely on the CE mark. BSI Group will serve as the notified body for Modular Medical for its CE clearance process. Modular Medical currently believes that it will obtain the CE mark during the first quarter of 2026.