February 9, 2024

‘swissdamed’ Registration Database: Launch date pushed to 2nd Half 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

Swiss Federal Council: Drafting New Negotiating Mandate to Remain in the EU Single Market

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 Inspects Swiss Medical Device & IVD Importers

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

Current Status: Swiss Acceptance of US FDA Devices

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

Swissdamed Registration Database: 2024 Release Dates Confirmed

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

2023 Mid-Year Regulatory Updates: EU, UK, and Switzerland

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 Confirms It Will Recognize EU MDR Transition Extension

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

Class B/C IVD Deadline to Appoint Swiss Authorized Rep: 31 Mar 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

Swissmedic Implements MDCG 2022-18 to Deal with MDR Certification Gaps

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.