To date, a CE certificate is the only way to make this technique accessible to everyone and to ensure it is reimbursed in countries like France. It will also encourage health authorities to break their silence and make recommendations on the method.
In our case, a CE certificate is issued for a device, not a method. Therefore, we need to focus on the object to get this contraceptive method recognized properly. This will help secure all DIY and emerging practices related to this technique by providing them with reassurance and scientific and medical recognition.
The journey is long and costly:
- 2022 - Incubation of Thoreme at Entrelac.coop
- 2023 - Homologation of the andro-switch manufacturing and distribution process (craft, low-tech, micro-industrial)
- 2024 - Monocentric safety test
- 2026 - Multicenter performance trial -> Pearl index will be officially calculated.
- 2028 - CE marking obtaining
This will make it the first medical device specifically designed for male contraception to be recognized and available to everyone in Europe.
Disclaimer: The information provided in this FAQ is based on user testimonials and is for general information purposes only. It does not constitute medical advice, diagnosis or professional treatment. We are not medical doctors. Always consult a qualified healthcare professional for personalized and appropriate medical advice. We accept no responsibility for any consequences arising from the use of the information provided in this FAQ. Send us an e-mail.
