Starting from May 26, 2021, in accordance with the full application of MDR (EU) 2017/745 Regulation on Medical Devices and in absence of any institutional agreement between Switzerland and Europe, Switzerland is officially considered a Third Country by Europe. The Mutual Recognition Agreement (MRA), which is a pre-condition to market products barrier-free, has not been updated, therefore the agreement between Switzerland and the EU has not been renewed. In fact, all EU Manufacturers cannot easily place their products on the Swiss market just as it has been until May 26, 2021. Even though there have been some negotiations with the EU for products already present on the market, as of today, Switzerland, does not automatically accept, for its own market, expired or new certificates from EU Manufacturers.

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