We at trackle have had ours right from the start Sensorsystem designed so that you can also use it for contraception - and not just fulfill a wish to have children. We know: many women are looking for a safe, hormone-free alternative to the pill.
Approval as a contraceptive in Germany is subject to high regulatory hurdles - today we want to explain to you what's actually behind it. Here we go:
Only class IIb medical devices are approved as contraceptives. That's pretty high, because after that there's only Class III. It would go too far to explain the classification in detail here, but you should know what medical device approval is all about:
What is tested on a medical device?
The manufacturer of a medical device proves to a "notified body", i.e. an external company, that the processes within the company meet all legal requirements for the manufacture of a medical device. Thoroughness is required here, because it would be fatal if a manufacturer used the wrong components, employed poorly trained personnel, or did not properly maintain its documentation. All of this can have an impact on health, which is why a medical device manufacturer must work according to a quality management system.
In addition, the technical set-up of a medical device is checked: which material is used? What laboratory results can the manufacturer show? How was the software programmed and tested? Which components were installed? The product is completely screened from A-Z.
And there is a large clinical part in the approval. Here experts check whether the manufacturer fulfills the clinical application well, i.e. what makes the medical product a “medicine” product. Did he give enough thought and literature studies beforehand? Do you have your own study results? Is there a risk in the application, has this been adequately investigated? And does he also check after the product is on the market whether everything is still running smoothly?
All of this is examined by various external specialists very regularly and, depending on the class of the product, in varying degrees of detail.
The same legal regulations apply to all medical device manufacturers in Europe - regardless of whether they are large corporations or a small start-up. For customers, the medical device certification is a sign that the processes and quality standards in these companies are really good and regularly checked and are safe.
By the way: only medical devices that are approved in the high risk class IIb may also use the term "contraception" in their marketing.