EU MDR v. CH MedDO: How are medical devices regulated on the Swiss market?

Due to the absence of the Mutual Recognition Agreement between the EU and Switzerland on the day the EU MDR became fully applicable on the European market, Switzerland lost its special status and became a ´’third country’’ as we reported previously. This resulted in the creation of a separate regulatory framework that started being applicable in Switzerland as of 26 May 2021.

The Swiss Medical Device Ordinance contains 110 Articles and 6 Annexes, and while it regulates medical devices on the Swiss market solely, it . . .

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