The CE mark is a way for manufacturers to indicate that the products follow 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.
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 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. In addition to the mandatory requirements, we have undergone a voluntary ISO 13485 certification, which shows that we have a structured Quality Management System that complies with additional European requirements regarding safety and quality for Medical Device manufacturers. We have also conducted multiple clinical studies, to evaluate the accuracy & effectiveness of Natural Cycles and to continue to move the research field forward.
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