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.
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.
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.
At the beginning of 2024, the clinical study will begin.
In total, a panel of about 200 men will be monitored in their use of Andro-switch for almost three years on several sites in France.
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.
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