The project

Accompanying Andro-switch

Our first project is the support of the company Thoreme and its founder Maxime Labrit, inventor of the Andro-switch ring. According to the European Medical Device Regulation (EU 2017/745), Andro-switch, as a contraceptive medical device, falls under class IIb, which corresponds to a fairly high degree of danger (from the least dangerous to the most dangerous: I, IIa, IIb and III).

To make Andro-switch available throughout Europe, it is necessary to obtain the CE mark attesting to its compliance with the European Regulation.

To obtain the CE mark, the safety and performance of Andro-switch must be demonstrated through a clinical study adapted to the requirements of the Regulation.

Certification course

August 2022 - Sept. 2023

Design of the clinical study

The clinical study of Andro-switch is currently being designed.

Our partners are working on its development and defining the size of the panel, the necessary duration and the modalities of the study.

This work will have to be validated by the authorities in order to launch the study at the end of 2023.

March 2023 - July 2023

Andro-switch production compliance

In order to launch the clinical study, Andro-switch rings must be produced in compliance with the Medical Device Quality standard (ISO 13485:2016).

Once the production unit is set up, a new generation of Andro-switch can be validated by the authorities to start the study.

2024 - 2026

Clinical study

At the beginning of 2024, the clinical study will begin.

In all, a panel of around 300 men will be monitored in their use of Andro-switch for almost three years at several sites in France.

Jan. 2027

CE marking audit and market access

Following the clinical study, an audit conducted at Thorème will verify the conformity of the product and the proof of its safety and performance.

This type of audit is carried out by bodies notified by the European Commission.

If this audit is positive, Andro-switch can be declared compliant with the requirements of the European Medical Device Regulation.

Financing

The certification of a medical device implies important costs due to the research time and the multiple skills it requires. To overcome these obstacles, our team implements a financing strategy with each entrepreneur it accompanies, by favoring public and and participatory financing. By joining us, our members also choose to finance the development of the male contraception.

Clinical development

Entrelac.coop guarantees the safety of users and the performance of each medical device that it accompanies to the market by establishing a clinical development strategy and managing each step of the clinical studies. By mobilizing the scientific community, we promote research in the field of reproductive health.

Market access

Each step forward is valuable for the development of male and testicular contraception, so we can offer each entrepreneur support from A to Z in his project: development plan, industrial compliance of the product, marketing strategy.

Entrelac.coop is the springboard for innovation for a more equitable and accessible contraception.

You are developing a solution for a more equitable contraception? contact us!