Medical Device Regulations

Amendments to two Swiss ordinances affecting the clinical testing, regulatory approval and marketing of medical devices in Switzerland came into effect on 1 September 20041. The ordinances - the MedicalDevicesOrdinance, MepV, SR 812.213, and the Clinical Trials of Therapeutic Products Ordinance, Vklin, SR 812.214.2 - are two of the regulations adopted in support of the Swiss Therapeutic Products Law (Heilmittelgesetz). They cover implants, instruments, medicinal equipment, in vitro diagnostics and materials for use with the above mentioned categories.