From dif­fer­ent sources we have heard that the intro­duc­tion of EUDAMED will be delayed – prob­a­bly for two years. In the mean­time, this has been con­firmed on the Euro­pean Commission’s EUDAMED website. 

This plan is off the table and the ini­tial go-live of the data­base will now be in 2022. 

Orig­i­nal­ly, the Euro­pean Com­mis­sion planned the go-live for March 2020. Mod­ules that wouldn’t be ready by then, were to be intro­duced at a lat­er stage. This plan is off the table and the ini­tial go-live of the data­base will now be in 2022. 

Please note that this will not mean that the MDR or IVDR appli­ca­tion will be delayed. How­ev­er, if this sce­nario becomes offi­cial­ly con­firmed, fur­ther guid­ance is expect­ed how issues regard­ing reg­is­tra­tion, vig­i­lance etc. will be han­dled. We will keep you informed about any progress in this direction.

Sources: EUDAMED website

If you are inter­est­ed in more EUDAMED relat­ed infor­ma­tion we warm­ly rec­om­mend the arti­cles list­ed below