We have exciting news: the Ovy App is now officially introduced as a certified medical device under the Medical Device Regulation (MDR)!
This means that the Ovy App has been approved as a contraceptive and fertility support tool in medical device class IIB. This step marks a significant milestone for us as developers of a cycle tracking app and demonstrates that the Ovy App meets the high security and performance standards of a modern medical product.
With MDR certification, we are strengthening our position as a leading health-tech company in the field of digital contraception and family planning. We are setting a benchmark for quality, safety, and innovation. Our goal is to establish the Ovy App as the standard in digital women’s health, supporting women and couples worldwide in personalized life planning.
Background: The MDR certification (Medical Device Regulation) is a legally binding EU-wide regulation that defines the standard for the safety and quality of medical devices. With this certification, the Ovy App joins an exclusive group of digital health solutions that meet the strict European requirements for quality, safety, and medical validation. The Ovy App was certified through an external, independent review process. This assessment includes comprehensive testing, risk evaluations, and stringent requirements for the software and its algorithm.
What does this mean for Ovy App users?
Mandatory Ovy App Update 7.0.0
All users are required to update the Ovy App to version 7.0.0 via the App Store or Google Play Store. This update is mandatory for continued use of the Ovy App. The previous “Cycle Tracking” feature will now be continued under the name “Contraception.” The algorithm will continue to evaluate data using the Symptothermal Method. No further action is required from users after the update – the switch to the new mode will happen automatically. The “Get Pregnant” mode remains unchanged.
Supported Operating Systems
As of version 7.0.0, the Ovy App will only support the following operating systems:
📱 iOS 16 or higher
🤖 Android 12 or higher
You can check your current operating system in your smartphone settings and update it if needed. If your device is running an OS version lower than the ones listed above, you will no longer be able to use the Ovy App. For more information, please refer to the FAQ.
New Instructions for Use
As part of the update, a new Instructions for Use document will be made available. It includes information on contraindications, IT security standards, and important regulatory notices. The instructions will be available in multiple languages via the Ovy App. We kindly ask you to review this information carefully.
Availability in EU Countries and Switzerland
The MDR certification of the Ovy App currently applies only to EU countries and Switzerland. Therefore, the Ovy App has been removed from app stores in all Non-EU countries.
Medical Device Regulation (MDR) Compliance
With the 7.0.0 update, the Ovy App has been adapted to comply with the regulatory requirements of the Medical Device Regulation (MDR). You can find more information here.
Please note that these changes are mandatory for us as a company in order to ensure the safe and legally compliant use of the Ovy App.
If you have any questions, our customer support is available on weekdays from 9 AM to 6 PM.
We have also answered important questions on this topic on our website.
Thank you for being part of our journey – we’re excited to continue shaping the future of women’s health together with you!
Warm regards,
Eva & Lina
