To date, a CE certificate is the only way that this ring technique will be accessible to everyone, and reimbursed in France, for example, or that the health authorities will finally come out of their silence and dare to make recommendations on the method.
In our case, a CE is issued for a device, not a method. We therefore need to go through the object so that this contraceptive method is finally recognized as it should be. This will make it possible to secure all DIY and emerging practices on this theme, for example, by giving them a reassuring aura and scientific and medical recognition of this technique.
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 - Obtaining CE marking
It will be 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.
