Not Just a Patch, a developer of medical CGM covers and patches solutions, has received U.S. Food and Drug Administration (FDA) clearance and European Class 1 medical device certification for its line of waterproof adhesive patches designed for continuous glucose monitoring (CGM) devices. These regulatory milestones will allow the company to expand its distribution footprint across North America and Europe, reinforcing market confidence in its CGM support products.

These approvals validate the safety, performance, quality and commitment of Not Just a Patch’s adhesive patches for CGM users and the growing list of distribution and retail partners.

“This is a critical regulatory step that reinforces our commitment to supporting people with diabetes through high-quality, medically validated CGM covers solutions,” said Pete Lomas, founder of Not Just a Patch. “Our patches are engineered to improve device wearability and patient confidence in daily activities and for all kinds of sports. And now they meet the stringent regulatory standards required for global distribution.”

The patches are designed to address a common challenge among CGM users: keeping the device securely in place during physical activity, showering, and sleep. The product incorporates several differentiators aimed at clinical usability and patient comfort, including:

• Breathable, hypoallergenic materials to minimize skin irritation
• Superior adhesion for active lifestyles, all kinds of sports, and extended wear
• Compatibility with leading CGM devices, including Freestyle Libre, Dexcom, Medtronic, and Omnipod
• A patented non-stick zone that avoids interference with the sensor, enhancing both comfort and sensor accuracy
   

The company emphasized that regulatory clearance will also benefit its distribution partners, many of whom operate across multiple regulatory jurisdictions. With both FDA and EU Class 1 certifications secured, Not Just a Patch becomes the first CGM patch brand with both FDA registration and EU Class I medical device certification and is now positioned to scale distribution with confidence in compliance.

Not Just a Patch reports growing international usage, with patches now shipped to over 40 countries and available through both direct-to-consumer and distribution channels. The products are sold in over 12,000 retail outlets and extensively online.