In August 2020, the Med­ical Device Coor­di­na­tion Group (MDCG) announced that the eco­nom­ic oper­a­tor reg­is­tra­tion or actor reg­is­tra­tion mod­ule will be avail­able as of Decem­ber 1, 2020. This mod­ule will serve to obtain the Sin­gle Reg­is­tra­tion Num­ber (SRN), which is a pre­req­ui­site to get access to oth­er EUDAMED 3 core func­tions. EUDAMED 3 will be a cen­tral tool for the imple­men­ta­tion of the med­ical devices and in vit­ro med­ical devices reg­u­la­tions (MDR and IVDR).

Just recent­ly, the Euro­pean Com­mis­sion has pub­lished a new web­site (link fur­ther below) with a num­ber of brief guid­ance doc­u­ments includ­ing a user guide and a help­ful video to gen­er­al­ly explain the reg­is­tra­tion process.

Please find below an overview of some essen­tial points:

Our team will do its best to pro­vide you with all the infor­ma­tion you need. Please have a look at the web­site to make your­self famil­iar with the new reg­is­tra­tion process. 

What has not been clar­i­fied yet is to what extent the actor reg­is­tra­tion process can be com­plete­ly or par­tial­ly del­e­gat­ed to a third party. 

Please note also that the MDR requires all eco­nom­ic oper­a­tors to reg­is­ter them­selves in EUDAMED 3 as of May 26, 2021. This, how­ev­er, is true under the con­di­tion that the data­base is ful­ly oper­a­tional. As a result, until fur­ther notice, the reg­is­tra­tion remains vol­un­tar­i­ly. We would nonethe­less sug­gest to ini­ti­ate the reg­is­tra­tion process as soon as possible! 

Source: Euro­pean Commission

To receive fur­ther infor­ma­tion on this sub­ject, please notice the fol­low­ing arti­cles and con­tent on our website