Ovy app approved as an MDR-certified contraceptive

Ovy app receives MDR approval. The cycle app from Germany is officially recognized as a Class IIb medical device.

Hamburg, April 14, 2025 - The Ovy App, an innovative cycle and health application from Germany, is now officially approved as a Class IIb medical device under the MDR (Medical Device Regulation). This makes the app a hormone-free alternative for contraception and family planning that meets the highest European quality and safety requirements.

Milestone for digital women's health

With MDR certification, Ovy joins an exclusive group of digital health solutions that meet strict medical validation standards. Users can monitor their cycle based on data derived from daily basal body temperature measurements and cervical mucus monitoring. The integrated algorithm uses this data to precisely calculate fertile days and supports women with natural contraception and pregnancy planning.

Foundation and vision

Ovy GmbH was founded by sisters Eva Leonhardt and Lina Wüller in Hamburg. Originally developed as a cycle app for monitoring the menstrual cycle, the Ovy app is now a comprehensive medical product. The founders' vision is to enable women to monitor their reproductive health safely, easily and without hormones.

The MDR certification confirms our high standards and gives women* the assurance that our app is medically sound.

Eva Leonhardt, co-founder and responsible for regulatory affairs at Ovy

Importance of MDR certification

The new European MDR regulation is considered the gold standard for medical devices. It ensures that only applications with scientifically validated algorithms and high data security are approved. This clearly sets the Ovy app apart from other cycle apps that are not certified.

Investors support the expansion

Ovy is supported by medical device manufacturer Beurer and publisher Klambt, among others. With approval as an MDR medical device, Ovy now wants to continue to grow and offer women and couples a digital, self-determined alternative for contraception and family planning. There was already an exciting interview with the Ovy brothers Lina Wüller on the Startbase.