EUDAMED eco­nom­ic oper­a­tor reg­is­tra­tion mod­ule avail­able as of Decem­ber 2020

Last year, the Euro­pean Com­mis­sion has announced that EUDAMED 3 as one cen­tral aspect for the imple­men­ta­tion of impor­tant med­ical devices reg­u­la­tion (MDR) and IVD reg­u­la­tion (IVDR) mech­a­nisms, will not be ful­ly avail­able before May 2022. In March 2020, the Com­mis­sion then con­firmed that the six mod­ules of EUDAMED 3 will be made avail­able sequentially. 

In August 2020, the Med­ical Device Coor­di­na­tion Group (MDCG) has issued guid­ance MDCG 2020-15. It says that the eco­nom­ic oper­a­tor 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 core functions. 

To read the offi­cial posi­tion paper, please fol­low this link to the web­site of the Euro­pean Commission.

Source: MDCG guidance

In order to receive more infor­ma­tions on Guid­ance Doc­u­ments you might chose from the fol­low­ing options

• Browse our web­site by key­word guid­ance doc­u­ments.
• Read our para­graph “Major aspects of the MDR”.
• Read our arti­cle “Most impor­tant changes on MDR“.
• Read our arti­cle “Ear­ly access to Sin­gle Reg­is­tra­tion Num­bers (SRN)“.
• Read our arti­cle “Device Reg­is­tra­tion and Lega­cy Devices“.
• Read our arti­cle “Updat­ed timetable for Eudamed“.