March 15, 2022
Swissmedic published additional updates regarding the Swiss Single Registration Number (CHRN) and device registration requirements. Quick Refresher - The Swiss Single ...
March 4, 2022
It appears that Swissmedic, despite some opposition by Swiss industry groups, will implement the IVDR on its date of application: 26 May 2022. Quick Refresher: As Casus ...
March 1, 2022
The deadline to appoint a Swiss Authorized Representative (AR) for mid-risk devices is nearly here. Manufacturers of Class IIb non-implantable ...
January 24, 2022
Originally, EUDAMED was to be fully functional on 26 May 2020 and align with the MDR's original date of application, ...
December 3, 2021
In April 2021, the Swiss Federal Council published the draft IVD Ordinance for public consultation. The draft regulation referred to ...
November 29, 2021
It has now been six months since the Swiss Federal Council and the EU Commission published that they cannot come ...
May 27, 2021
Swexit Update: Both the EU Commission and Swiss Federal Council released statements that they could not come to terms regarding ...
December 1, 2020
The Medical Devices Regulation (MDR) date of application is looming: 26 May 2021. And yet, still no update has been ...