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Switzerland must be considered a foreign country regarding the CE marketing of medical products.
Switzerland must be considered a foreign country in the marketing of Medical Products. The European Commission published on May 26, 2021, a note addressed to economic operators related to the situation of the EU-Switzerland Mutual Recognition Agreement for medical products.

In this note, it specified:
For new products, that is, those placed on the market after May 26, 2021, Swiss manufacturers will be treated like any other manufacturer from a third country intending to introduce medical products into the EU. They must have an Authorized Representative established in the European Union. All products requiring a Notified Body must be accredited by the European Union. Distributors of these products intending to introduce them into the EU will become importers, so in the case of Spain, they must obtain the prior operating license for facilities granted by AEMPS. For now, this situation does not affect in vitro products, as the application of the IVDR is scheduled for May 26, 2022.
That said, products placed on the EU market before May 26, 2021, can be marketed in Spain, provided the company has documentation proving that the products were manufactured and placed on the market before the mentioned date. This documentation must unequivocally identify the product and its quantity, i.e., its serial number, reference, batch, name, etc. Of course, they must have their CE Declaration of Conformity, proper labeling, and instructions (when applicable).

The AEMPS has decided to grant a deadline until September 30, 2021 to comply with all the requirements.