New web­site on actor reg­is­tra­tion in EUDAMED 3 available

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:

• Man­u­fac­tur­ers must set up an EU Login account
• Man­u­fac­tur­ers will be guid­ed through a num­ber of screens and prompt­ed to pro­vide gen­er­al com­pa­ny and con­tact infor­ma­tion. In this con­text, man­u­fac­tur­ers will also be prompt­ed to upload an orga­ni­za­tion iden­ti­fi­ca­tion document.
• Man­u­fac­tur­ers will be required to iden­ti­fy the Autho­rized Rep­re­sen­ta­tive and upload the belong­ing man­date sum­ma­ry doc­u­ment form. The lat­ter is avail­able on the web­site for down­load. The entire process may only be com­plet­ed when the Autho­rized Rep­re­sen­ta­tive is already reg­is­tered in EUDAMED and a valid MDR/ IVDR man­date is in place. 
• Man­u­fac­tur­ers are prompt­ed to add the details on the Per­son Respon­si­ble for Reg­u­la­to­ry Com­pli­ance (PRRC).
• The details of the con­tact per­son will be tak­en for the first user, who in turn will be the Local Actor Admin­is­tra­tor (LAA). The web­site also includes a brief overview of the dif­fer­ent pos­si­ble profiles.
• The LAA must sign and upload a dec­la­ra­tion on infor­ma­tion secu­ri­ty, which is also avail­able on the website. 
• Once the man­u­fac­tur­er has sub­mit­ted its reg­is­tra­tion request, the Autho­rized Rep­re­sen­ta­tive and final­ly the com­pe­tent author­i­ty will ver­i­fy the request. Upon com­ple­tion, the SRN is assigned.

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

• Actors reg­is­tra­tion, Euro­pean Com­mis­sion website
• Major aspects of the MDR
• Most impor­tant changes on MDR
• Get ready for the eco­nom­ic oper­a­tor reg­is­tra­tion in EUDAMED
• Ear­ly access to Sin­gle Reg­is­tra­tion Num­bers (SRN)
• Device Reg­is­tra­tion and Lega­cy Devices
• Updat­ed timetable for Eudamed