The Swiss Federal Council and EU Commission have each approved their final negotiating mandates. As a result, this month the EU and Switzerland will resume formal negotiations to try and restore mutual recognition.

Switzerland’s update is available: HERE

The EU’s update is available: HERE

The Purpose of the negotiations

It is to try again, to put an updated 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: what the EU felt was an ‘unbalanced playing field’ and Swiss citizens unwilling to concede on certain points, such as immigration.

As a result, while the existing Swiss-EU agreements could remain ‘as is’, the EU would not update the agreements to account for amended/replaced legislations. Nor would they put any new agreements in place.

For more background, please read the EU Parliament Briefing: EU-Swiss trade relations and the institutional framework agreement

Why is this important to the medical device industry?

One of the first industries to be impacted by lack of a new 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.

Measures had to be put quickly into place to cover the gaps, such as:

If the end result of the new negotiations is “approval” on both sides, then Switzerland once again becomes part of the EU Single Market. The above measures would then no longer be needed.

What’s next?

The objective is to finalize negotiations in 2024, after which it will go up for vote.

Some of the main points of contention, which caused the previous agreement to collapse, were around immigration, welfare, and wage protection. While the outlook in Switzerland is more favorable than it has been in previous years, these still appear to remain as ‘sticking’ points to implementing a new agreement.

For example, an excerpt from the November 30, 2023 Swiss Population Survey on the EU Negotiating Mandate (informal English translation):

“The statement that immigration from the EU is becoming a major burden on our social welfare system enjoys the greatest support (62% agree/strongly agree), followed by the arguments that this same immigration from the EU is driving up rents and property prices (61%) and that Switzerland has lost control over immigration (52%). However, in view of this criticism, only a clear minority of respondents agree that Switzerland is not at all dependent on the bilateral agreements (30% strongly/somewhat agree).”

That said, the Swiss Federal Council has been working hard to lobby the new negotiating terms internally, within the Swiss cantons (states).

The EU wants these topics addressed to provide, what they feel, is fairer reciprocity. The EU’s FAQs state that all elements of the package have to advance together, i.e., both the controversial and non-controversial agreements are considered part of a single package.

Will Switzerland rejoin the European market, or stay cut out? At this time, it is hard to predict.

Stay tuned for updates. Casus will be monitoring the negotiations as they progress.

Further Reading

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