MiniMed, a global leader in diabetes technology, has announced CE (Conformité Européenne) Mark for the MiniMed Flex, the company’s next generation, app-controlled insulin pump designed to fit seamlessly into daily life.
“This is a proud moment for our team and an important step forward for people living with diabetes across Europe,” said Que Dallara, CEO of MiniMed. “We believe diabetes technology should deliver best-in-class clinical outcomes while being discreet enough to fade into everyday life. This milestone brings us closer to making that experience available to more people across Europe.”
Designed to help reduce the daily burden of living with diabetes, the MiniMed Flex system combines dependable clinical performance with greater freedom and discretion. About half the size of other MiniMed pumps, it is MiniMed’s most compact insulin pump while still holding 300 units of insulin. With an easy-to-use app interface for discreet control, it is designed to be worn more flexibly and comfortably – whatever a person chooses to wear.
Powered by MiniMed’s most advanced SmartGuard algorithm, the MiniMed Flex system joins the MiniMed 780G system as the only systems with Meal Detection technology, which detects rapid rises in sensor glucose and delivers a correction dose when meal boluses are occasionally missed or carbohydrate counts are underestimated.
Working seamlessly in the background, the system continuously adjusts and autocorrects insulin delivery up to every 5 minutes using real-time glucose readings from a MiniMed sensor, helping users spend more time in target range with less daily effort. Real-world results have demonstrated 80% Time in Range (TIR)1,2 with recommended settings – exceeding worldwide TIR recommendations.
Compatible with MiniMed’s Extended infusion set, the system can also support up to seven days of wear and up to 96% fewer injections compared with traditional insulin therapy.
The CE mark announcement builds on a series of recent innovations introduced in Europe, including the MiniMed Go Smart MDI system and the ongoing rollout of the Instinct and Instinct Go sensors – made by Abbott for use with MiniMed smart dosing systems. MiniMed recently launched the MiniMed Flex system with both the Simplera Sync and Instinct sensors in the United States.
“What stands out most to me about the MiniMed Flex system is how simple and seamless it feels. The pump is lighter and being able to manage everything from my phone means I hardly ever interact with the pump itself,” said Mattie Fisher, a MiniMed customer and participant in an early customer pilot in the US.
MiniMed anticipates the European commercial launch of the MiniMed Flex system will begin with a customer experience phase later this year in select European countries, followed by a broader commercial launch toward the end of 2026. The Company will showcase MiniMed Flex at the European Association for the Study of Diabetes (EASD) in Milan from 28 September – 2 October.
MiniMed also today announced a programme planned for select European countries that will allow eligible existing and new MiniMed 780G system users to enrol for an upgrade to the MiniMed Flex system when it becomes commercially available in their country.
In Europe, the MiniMed Flex system is indicated for use by individuals aged two years and older with insulin-treated diabetes (type 1 and type 2). The system is also CE Marked in Europe for use during pregnancy.
