The Swiss Federal Council has begun formal steps to re-initiate negotiations with the EU. The announcement is available: HERE
It is to try again, to put an overarching agreement in place. This would allow continued mutual recognition between the two regions and allow Switzerland to remain part of the European Single Market.
The previous discussions broke down over larger political issues, and what the EU felt was an unbalanced ‘playing field’.
One of the first industries to be impacted by the lack of a new overarching agreement was the medical device sector. With the EU unwilling to update the Mutual Recognition Agreement to cover the MDR and IVDR, Switzerland was left a third country on their respective application dates. Among other things, non-Swiss manufacturers had to scramble to appoint a Swiss Authorized Representative and Swiss manufacturers to appoint an EU Authorized Representative.
For more background, please read the EU Parliament Briefing: EU-Swiss trade relations and the institutional framework agreement
Switzerland and the EU have conducted exploratory talks since 2022 on an agreement package, with the last one occurring on 27 October 2023. They now consider the exploratory talks concluded.
The Swiss Federal Council also conducted internal discussions with the cantons (i.e., the member states of the Swiss Confederation), social partners, and the business community.
As a result of the above, they feel they are in a position to prepare a new draft negotiating mandate.
The next step is that the Swiss Federal Council will draw up a negotiating mandate. Then, by the end of this year, they will decide if they will adopt it and submit it to the Foreign Affairs Committees (FACs) and the Conference of Cantonal Governments (CCG) for consultation.
Switzerland continues to be motivated to remain a part of the European single market. This is not only related to medical devices but to the continued recognition of textiles, machinery, agricultural products, electricity, etc.
That said, it will not happen overnight. Further, being a direct democracy, it requires buy-in from a majority of the Swiss population.
Casus will keep you apprised as news develops.