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.
January 12, 2023
Switzerland announced it will implement MDCG 2022-18, to deal with MDR certification gaps under MDR Article 97. Find out the requirements and how to comply.
January 4, 2023
Find out what regulatory news you may have missed from Swissmedic in 2022, and the upcoming 2023 deadlines for medical devices & IVDs in Switzerland.
December 1, 2022
Manufacturers of Class D IVDs must appoint a Swiss Authorized Representative by 31 December 2022. This is required even if the device is CE Marked to the IVDD.
November 28, 2022
Today Swiss Parliament voted to allow FDA approved devices onto the Switzerland market, in addition to European CE marked devices. Read here to find out more.
