Medical devices - Switzerland is now a third country

On 26 May 2021, the worst-case scenario became reality - Switzerland became a third country for trade of medical devices without a valid MRA (Mutual Recognition Agreement). With the termination of the negotiations on the institutional framework agreement, which was communicated on the same day, the hopes for a delayed update of the MRA have further diminished. While exporting companies have completely lost access to the European market overnight (unless they have already appointed an EU REP (European Representative)), Swissmedic has been completely cut off from the information in the EUDAMED database and certificates from Swiss notified bodies have been declared invalid for Europe, importing companies still have a few months to adjust to the new situation. Medical devices that still have a valid certificate according to MDD or those that have already been certified or declared compliant according to MDR will continue to have access to the Swiss market. However, Swiss AR’s - graded according to risk class - must be appointed within a very short period of time. For class III products, this is already mandatory by 31.12.2021, for class IIa and IIb by 31.3.2022, for class I products by 31.7.2022. Accordingly, importing companies must quickly contact their manufacturers, discuss the further procedure and find and contract a Swiss AR. SWISS MEDTECH provides useful guidances and information; sample contracts for Swiss representatives can be ordered. Swiss economic actors must register with Swissmedic still this year (by 26 November 2021). This requires a completed form and an excerpt from the Trade Registry, as well as a mandate (Swiss AR) if necessary.