Natural Cycles is available as a method of birth control in the US, Europe, Canada, Australia, and Singapore. In countries outside the US, Europe, Canada, Australia, and Singapore, Natural Cycles is intended to be used for fertility monitoring.
Our certifications have been granted based on mandatory clinical data that demonstrates that the effectiveness rate of Natural Cycles is 93% with typical use and 98% with perfect use. Read more about our effectiveness here.
Natural Cycles is the first CE-marked Class IIb medical device (CE0123) for use as a method of birth control.
The CE mark is a way for manufacturers to indicate that a product follows the mandatory European standards and laws, including those related to health and safety. Many different types of products need to be CE marked before they can be sold within the European Union, and the CE mark also covers the UK.
There are different ways to become a CE mark product, depending on the type of product and on how you plan to market the product within the EU. Machines and apps, such as Natural Cycles, that are used within or for healthcare are often defined as medical devices, which by law requires the products to be CE marked and follow certain standards.
At Natural Cycles, we put the safety and security of our users first, including following the rigid safety standards of the European Union. This allows us to put a CE mark on Natural Cycles. It requires us to conduct a thorough analysis of any potential risks with using Natural Cycles, to conduct an evaluation of the clinical performance of Natural Cycles and much more. We have also conducted multiple clinical studies, to evaluate the accuracy and effectiveness of Natural Cycles and to continue to move the research field forward.
In addition to the mandatory requirements, Natural Cycles has also undergone a voluntary ISO 13485 certification. You can read more about this below.
Natural Cycles is the first and only birth control app to be cleared by the FDA. Natural Cycles is cleared as a Class II medical device, which means that it can be used as a birth control method in the US.
The FDA clearance is based on evaluating the results of three clinical studies, which included over 20,000 users, as well as a prospective study of more than 15,000 users. You can read more about our initial FDA clearance here. Natural Cycles received a second FDA clearance to integrate with third party wearables.
Listed in the ARTG in Australia
Since 2020, Natural Cycles is listed in the ARTG (the Australian Register of Therapeutic Goods), meaning that the app can be used as birth control in Australia.
Listed in the SMDR in Singapore
Natural Cycles is also listed in the SMDR (the Singapore Medical Device register) since 2021.
Authorized for sale by Health Canada
Natural Cycles received a Class II Medical Device License from Health Canada in December 2023.
At Natural Cycles, we have a quality management system. Natural Cycles is certified with EN ISO 13485, which is the latest harmonized standard for medical devices. This means that every step of the product cycle is guided by processes which are consistent with state-of-the-art engineering and management processes, and ensures that you can benefit from the highest standards of quality and safety. Processes at Natural Cycles have been audited internally and externally.
We put you first in everything we do — from designing the app, to implementing and testing it, marketing, and supporting you as a user.