Tüv Süd, one of the leading notified bodies worldwide, approved Natural Cycles as a class IIb medical device intended to be used for contraception. This means women across Europe now have a new, clinically tested, regulatory approved contraception method to use besides condoms, the Pill and IUDs.
Natural Cycles was created by husband and wife team (left) Dr Raoul Scherwitzl and Dr Elina Berglund. Dr Elina Berglund is one of the scientists who discovered the Higgs Boson which led to the Nobel Prize in 2013. Natural Cycles is a hormone- and chemical-free birth control alternative and, in 2016, a clinical study showed that the app was as effective as The Pill*. This is good news for the UK’s estimated 3.5m women who use hormonal contraception and following the 2016 University of Copenhagen clinical study, being the largest of its kind with 1 million women, and being confirmed as a link between hormonal contraceptives and depression**.
Natural Cycles works by recording your daily temperature. A smart algorithm then determines whether you are fertile on that day so you accurately know if and when to have protected intercourse - and this helps to prevent (or plan) a pregnancy.
Dr Elina Berglund, CTO and co-founder of Natural Cycles said: “Women around the world are interested in exploring effective non-hormonal, non-invasive forms of contraception - and now they have a new, clinically verified and regulatory approved option to choose from. Our high quality clinical studies, together with the required regulatory approvals, means we can provide women everywhere with a new option for contraception. Natural Cycles allow women to better understand their bodies so they can make choices that are right for them.”
The Natural Cycles app joins a range of medical products that have been clinically tested and regulatory approved to achieve a IIb classification, such as intensive care monitoring and alarm devices, anaesthesia machines, blood pumps for heart-lung machines and blood bags, to name a few. Natural Cycles is used by over 150,000 women in 161 countries and is the first fertility tracking app for women to be regulated as a medical device. The device is available on naturalcycles.com, the App Store for iPhone, Apple Watch and iPad, and Google Play Store.