MDCG Q4 Working Group Meeting Minutes: Progress on EUDAMED, Harmonized Standards, and more
17 December 2024
UK PMS Requirements: Statutory Instrument (SI) 2024/1368 Published and Effective Mid-2025
26 December 2024Today the Swiss Federal Council issued a press release advising that the Swiss-EU negotiations are in the final stages. The announcement is: HERE
Background
Earlier this year, Switzerland and the EU commenced negotiations to update the long-standing agreements between the two regions. Please read this previous March 2024 article for more details: Switzerland-EU Mutual Recognition – New Negotiation Discussions Underway
Negotiation Outcome
The negotiations have been substantively concluded, in a way the Federal Council feels “correspond to Switzerland’s interests and pave the way for the next steps towards implementing the package strategy”. Therefore, they have instructed the relevant departments to prepare for formal conclusion of the negotiations.
Next Steps
There are still several steps before a final decision can be made:
- The negotiated text will be cleaned up and finalized, and translations made
- In parallel, the Swiss Federal Council will finalize talks with institutional partners (cantons and parliament)
- In the spring of 2025, the chief negotiators on the EU & Swiss sides will initial the final text of the agreements
- The Swiss Federal Council will decide if they want to launch a regular consultation on the draft before summer 2025
- The structure of the package and the type of referendum* will be made once the consultation process commences
- They aim to submit the draft to Parliament by early 2026
From an overall timing perspective, the process will likely take a few years, i.e., status quo for the next 2-3 years.
*As Switzerland is a semi-direct democracy, referendums enable citizens to vote on specific issues. These are categorized as either mandatory or optional, depending on the issue. Mandatory referendums generally require approval from both a majority of voters and a majority of cantons (a double majority). Optional referendums require only a simple majority of voters to pass.
