As well known, as of 26 May 2021 – following the full implementation of the MDR (EU) 2017/745 Medical Devices Regulation in Europe and in the absence of an institutional agreement between Switzerland and Europe – Switzerland became a Third Country for the EU.
The regulatory system for Medical Devices has changed in Switzerland, in particular with the Medical Devices Ordinance ODmed SR 812.213.
As a result, EU manufacturers who want to market their Medical Devices in Switzerland are confronted with numerous new requirements to be fulfilled in accordance with progressive deadlines. In this process of adapting to the new requirements in Switzerland, it is important to follow specific steps and to make sure that these steps are correctly carried out.
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