Quality Assured & Recognized

2017 – Years of high-quality research, compliance audits and the implementation of regulatory processes have led to Natural Cycles becoming the first CE marked app (CE0123) in Europe intended to be used as birth control.

 

2018 – The US Food and Drug Administration (FDA) cleared Natural Cycles for use as a digital method of birth control.

Class II Medical Device

In Europe, Natural Cycles is the first CE-marked Class IIb medical device (CE0123) for use as a method of birth control. Depending on its intended purpose, a medical device is categorized into three different classes based on risk and regulatory control  – the higher the classification, the greater the level of assessment required. This means for example that medical devices in Class II/IIb (USA/ Europe), but not those in Class I,  require third-party involvement to assess the clinical evidence.

The US Food and Drug Administration (FDA) granted Natural Cycles’ application for De Novo classification as a Class II medical device.

Both the CE marking and the FDA clearance were based on a large body of clinical data which showed an effectiveness rate of 93% effective with typical use.

We are audited each year by the Notified Body TUV SUD to ensure the app continues to demonstrate the effectiveness levels shown in our published studies.

In countries outside of Europe and the US, Natural Cycles is intended to be used for fertility monitoring.

ISO Standard

We have an extensive quality management system to ensure that Natural Cycles maintains the highest standards in quality and safety. Natural Cycles is certified according to ISO 13485:2016, which sets the international standard for medical devices. This means that every step of product development is guided by a process which is in line with state-of-the-art engineering and management processes. These processes at Natural Cycles have been checked by one of the leading auditing organizations in Europe.

Elina Berglund, CTO & Co-founder of Natural Cycles

- "Natural Cycles plays a huge role in women's lives, which humbles us. So we always have their best interest at heart in every decision we make.”