As from 26 May 2021, EU manufacturers of medical devices intending to (continue to) place their products on the Swiss market must comply with additional requirements. Which requirements exactly must be met by an individual manufacturer depends on the class of the product in question and on the applicable distribution channel. Just designating a «Swiss Authorised Representative» will not suffice; rather, there are several different additional requirements to be complied with. With regard to the applicable requirements, the particular circumstances of each individual case must be taken into account. The information available on this website shall assist EU manufacturers in identifying the relevant requirements and conditions.
As a first step, a distinction must be made depending on whether the product to be placed on the Swiss market is a product in accordance with the MDD or the MDR: