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.