Approved as a contraceptive - what does that mean exactly?
Perhaps during your research on hormone-free contraception, you’ve come across one or another cycle computer.
Many of the competing products advertise with „cycle monitoring,“ „getting to know your own cycle better,“ or „recognizing the fertile phase.“ The word „contraception“ is cleverly avoided – and we’ll also explain to you why:
Almost none of these systems are officially approved as contraceptives. They do not meet the legal standards to which contraceptive products are subject and are therefore not allowed to call themselves contraceptives.
Is trackle a contraceptive?
trackle is a contraceptive. Only a few manufacturers in Europe are allowed to formulate such a simple sentence for their products because contraceptives in Europe have to meet very strict legal requirements. Those who do not meet these requirements have to come up with more complicated phrases and beat around the bush with „monitor your cycle“ or „get to know your body“. In Europe, a contraceptive is a Class IIb medical device, i.e. the second-highest class of medical devices – and the higher the class, the higher the requirements placed on the manufacturer and the product.
Clinical Evaluation
As part of the clinical evaluation, the manufacturer must demonstrate through scientific studies that the product is indeed capable of effectively being used as a contraceptive.
Biocompatibility
The manufacturer must demonstrate that their product is completely safe for use in the body and does not cause mucosal irritation, cytotoxic effects, or carcinogenic effects. The manufacturer must provide evidence of this through testing in specially accredited laboratories.
Product Development
In product development, all components and processes used must comply with state-of-the-art technology.
Software Development
In software development, the classification of risks in the event of software failure for end-users must be determined, and accordingly, special requirements for planning, development, testing, and documentation of the software must be met.
Software development starts with fundamental questions: Who will use the software? What exactly will this person do with the software and under what circumstances? What is the best possible function of the software to meet these requirements?
Comprehensive change processes must be followed for any changes to any software to ensure that no errors can occur and to demonstrate through comprehensive testing that any application, even with the input of incorrect or contradictory data, always provides correct results at all times and under all circumstances.
Manufacturing of Products
The manufacturer must ensure at all times and for each component that it is always traceable what exactly was installed and that the quality of the installed parts is flawless. They must closely monitor all suppliers and, of course, all products supplied by the suppliers. They must monitor the quality of the products throughout the manufacturing process so that defective devices do not enter circulation.
Product Monitoring
Once the products are in the hands of users, the manufacturer must comprehensively monitor their products and have established processes prepared for irregularities or even hazards to be able to react immediately and without delay in case of emergencies to prevent potential harm to users.
Regular Process Audits
And it is not enough for the manufacturer to define and implement appropriate processes for the mentioned (and numerous other requirements); these processes are regularly audited and reviewed at least once a year by a so-called „Notified Body“, in the case of trackle, by TÜV Rheinland. Only with the issuance of the certificate by the Notified Body, confirming compliance with all legal requirements independently, may a manufacturer ‚place their contraceptive on the market‘, i.e., make it available for use by people.“
What does it mean to you to use a certified contraceptive?
A medical device placed on the European market must meet stringent regulatory requirements. You can rely on this: trackle GmbH’s processes are regularly audited and monitored. Based on this monitoring, our product is permitted to bear the CE mark. Because trackle is a Class IIb medical device, it is one of only a few products on the European market approved for contraception and is permitted to use this term in its advertising.
You can pay attention to which products explicitly allow „contraception“ and which ones don’t use this word, but instead refer to ovulation trackers, fertility monitoring, or similar euphemisms.
And that’s not all: trackle is not only officially approved for contraception, but also follows the guidelines of the symptothermal method, which has been recommended by the German Society for Gynecology and Obstetrics (DGGG) as the only safe method of contraception in Natural Family Planning (NFP) since 2024. Trackle uses this method for evaluation – and this is essential for contraceptive safety.
trackle is therefore a safe product produced by a regularly and independently tested manufacturer, allowing you to use it safely.
