Pearl Fertility reached a great milestone recently: The Pearl Fertility App and test kits are now CE certified and one of the first mobile medical apps to receive this status!
After one year of building up technical documentation and clinical evidence we are finally ready to reach a new continent. We’ve learned SO much during this process and are very thankful for having been able to work together with TÜV and for the efforts of the whole Pearl team.
What does CE mean?
The abbreviation "CE" means "Communauté Européenne", the French term for "European Community". It stands for EU-wide harmonized regulations. It is intended to simplify the European movement of goods. It’s the equivalent of an FDA approval in the European Union and it certifies that Medical Devices are safe, and perform according to the highest standards backed by science. With this achievement the Pearl App is one of the first mobile apps to obtain the status of Medical Device, and to be certified as an In Vitro Diagnostic Medical Device.
What is an In Vitro Medical Device and why is Pearl certified as one?
An In vitro diagnostic (IVD) is a term for medical devices for medical laboratory examination of samples taken from the human body. These are examined outside the body (in vitro is Latin for 'in glass'). Since Pearl works with samples of your urine in order to make an analysis of your hormones along the cycle, it falls under this category and needs to meet the special regulations that apply for such devices.
What does “CE certified” mean?
With the CE mark on our product, we officially declare that all legal requirements for Pearl are met. The aim of the CE marking is to document the fulfilment of the basic safety requirements of the applicable EU regulations, e.g. for toys, machines- or in our case- medical devices.
This certification is a clear seal of quality for us. In the rapidly growing market for health apps, Pearl Fertility is now one of less than one percent certified as a medical device and thus sets its digital health solution very clearly apart from the usual lifestyle apps.
Pearl’s CE certificate
Before the CE mark could be put on Pearl, a conformity assessment and the issue of an EU declaration of conformity was required. For a successful conformity assessment procedure a notified body must be involved. In our case, this notified body was TÜV Deutschland. So called TÜVs (Technical Inspection Associations) are German and/or Austrian businesses that provide inspection and product certification services. With their many years of experience, they reliably supported us in determining conformity with the applicable EU directives. This enables us to fulfil our responsible task as a manufacturer and secure access to the European market. Due to this recent CE marking, we will also be updating our website and packaging. But rest assured, the Pearl test will remain the same innovative, accurate fertility test and our team will continue to support you in any way we can!
In which countries is Pearl Fertility now available?
Pearl is now available in the U.S., Canada, Australia, South Africa and Europe including Switzerland, the UK, Finland, Denmark and Sweden, Iceland and even Turkey! We’re delighted to grow our community of Pearl users and can’t wait to accompany you on your journey to get to know your body, your cycle and yourself better- no matter where you are!
Why is it important for a product to be approved by the FDA?
The FDA is the US "Food and Drug Administration", the state supervisory authority responsible for the control of all goods placed on the US market. This also includes all imports, which is why the guidelines and regulations of the US authority are also important for foreign manufacturers. For exporters to the USA these are even binding, because not every product approved in Germany or the EU is automatically FDA-compliant. If a product is “FDA approved”, it means that it has been independently evaluated for safety and effectiveness and given a thumbs up by the FDA.
Are there other Fertility Tests with CE AND FDA clearance?
The list of apps that are CE certified AND cleared by the FDA is actually pretty short. In fact, less than one percent of today’s health apps are certified as a medical device and Pearl is one of the first apps to receive this status. As the quality and validity of Pearl is one of our top priorities, this marks a great milestone for us. You can find a full list of CE certified and FDA cleared apps here.
Thank you for your support dear Pearl Community!
We will continue making Pearl a product that speaks for itself bringing the highest quality and standards into it.