The Ovy App, a German menstrual cycle tracking application, has received Class IIB medical device certification under the European Medical Device Regulation (MDR), officially qualifying it as a digital contraceptive. This regulatory achievement, positions the Hamburg-based app among a select group of digital health solutions meeting stringent European standards for safety and efficacy.
Founded by sisters Eva Leonhardt and Lina Wüller, Ovy was initially launched as a Class I MDD cycle tracking app. With this new certification, the app is now approved for both contraception and pregnancy planning, offering users a hormone-free alternative to traditional birth control methods.
The Ovy App functions by calculating a user’s fertile days through an algorithm that processes daily basal body temperature readings and cervical mucus observations. Temperature data can be automatically transmitted via a compatible Bluetooth thermometer, streamlining the tracking process.
“The MDR certification confirms our high standards and provides women with the assurance that our app is medically validated,” explains Eva Leonhardt, co-founder and head of regulatory affairs. “Our vision is to offer women a safe, simple, and hormone-free way to manage their reproductive health independently and based on data.”
The MDR certification represents a significant regulatory hurdle, as it requires validated algorithms and stringent data security protocols. The certification process ensures that health applications meet medical-grade quality standards before being approved as contraceptive devices.
Digital fertility awareness methods have gained increasing attention as alternatives to hormonal contraception, with growing demand for evidence-based, non-hormonal options. The Ovy App operates on a subscription model and works in conjunction with the company’s Bluetooth-enabled basal thermometer.
Beyond its core functionality, Ovy’s product portfolio includes additional apps, proprietary Bluetooth hardware, and test strips. The company has secured investment from medical device manufacturer Beurer and publishing house Klambt.
