SwissMedTech expects "worst case scenario" for medical device manufacturers
The Mutual Recognition Agreement (MRA) between the EU and Switzerland remains unsigned. If no agreement is reached with regard to the trade agreement, Switzerland will (continue to) be considered a "third country" in the future with respect to medical devices.
What this means for Swiss manufacturers is that they will be required to satisfy the requirements applicable to third countries for all medical devices as of 26 May 2020.
What this means for European distributors which purchase devices in Switzerland is that they will be required to comply not only with the obligations for distributors in accordance with Article 14 of the MDR but possibly also with those of importers in accordance with Article 13 of the MDR, unless a political resolution in the matter of the MRA is reached prior to 26 May 2020.