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.
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