From this page you can download SSI Diagnostica's ISO 13485 certificate. 

ISO 13485

Info for distributors concerning new EU regulation MDR and IVDR

SSI Diagnostica antisera and antigen products are classified as general IVDs (Class A or B) so there will be no change of the CE-marking for these.

Further guidelines are awaited to be able to classify our ImmuView and PCR product lines correctly.

We are confident that, if required, we can provide CE-certificates from a Notified Body in time before May 2022.

All distributors will be contacted directly if any changes should occur to the CE-marking of our products.