Swissmedic hosted an IvDO/IVDR seminar in early November 2022.
The seminar was conducted as a live stream and not recorded. However, the presentation materials are available: HERE
Below are some highlights for IVD manufacturers to consider.
Swissmedic hosted an IvDO/IVDR seminar in early November 2022.
The seminar was conducted as a live stream and not recorded. However, the presentation materials are available: HERE
Below are some highlights for IVD manufacturers to consider.
Read: What is a CHRN?
For more information about the IvDO, please read: Switzerland Adopts IvDO/IVDR
Struggling to keep up with all the looming deadlines in Switzerland, Europe, and the UK? Download our: Important Dates Chart
*Both IVDD and IVDR CE marked devices require a CH-REP. The classification is based on what the device classification will be under the IVDR. In order to qualify for the transition period, the device must already have been on the European market prior to the IVDR’s date of application (26 May 2022). Any IVDs newly placed onto the market after that date do not qualify for the transition period.
If you have any questions about the process to market in Switzerland, please contact us for support.