March 13, 2024
This month the Swiss Federal Council and EU Commission will resume formal negotiations; if successful, this will restore mutual recognition for medical devices. Find out the details here.
February 9, 2024
Swissdamed is being postponed, due to continued on work on the IT infrastructure. Find out the new 'go-live' dates and when its use will become mandatory.
November 9, 2023
The Swiss Federal Council is drafting a new EU negotiating mandate. If accepted, it would put Switzerland fully back into the EU Single Market, including for medical devices. Find out the plan, timing, and next steps.
October 19, 2023
Swissmedic recently inspected local medical device and IVD importers for compliance. Find out the results and how they may impact your products.
August 31, 2023
Swiss Parliament approved allowing FDA devices almost one year ago (Nov 2022). What is the progress as of today (Aug 2023)? Read here for the most current status.
August 10, 2023
Swissmedic released an update on swissdamed, the medical device registration database. It includes updated 'go-live' dates & user manual. Click for the full details.
June 19, 2023
Find out the major regulatory changes of the 1st half of 2023, and expected changes for the remainder of the year in Europe, the UK and Switzerland.
March 30, 2023
Swissmedic announced today that legacy CE Certificates granted further extension in Europe, will be recognized in Switzerland. Click here for more details.
March 1, 2023
Manufacturers of Class B/C IVDs must appoint a Swiss Authorized Representative by 31 March 2023. This is required even if the device is CE Marked to the IVDD.