Get ready for the eco­nom­ic oper­a­tor reg­is­tra­tion in EUDAMED

In a recent arti­cle we have report­ed that the EUDAMED eco­nom­ic oper­a­tor reg­is­tra­tion mod­ule will be avail­able as of Decem­ber 2020.

The cor­re­spond­ing reg­is­tra­tion will trig­ger the assign­ment of a Sin­gle Reg­is­tra­tion Num­ber (SRN). With­out an SRN, man­u­fac­tur­ers, autho­rized rep­re­sen­ta­tives and oth­er eco­nom­ic oper­a­tors won’t be able to oper­ate in EUDAMED. Fur­ther­more, eco­nom­ic oper­a­tor reg­is­tra­tion is a require­ment also for man­u­fac­tur­ers that will con­tin­ue to place their prod­ucts on the mar­ket under the med­ical devices direc­tive (MDD) beyond May 26, 2021. 

Although the reg­is­tra­tion dead­lines apply once EUDAMED becomes ful­ly func­tion­al, mdi Europa thinks it is high­ly rec­om­mend­able to apply for an SRN as ear­ly as possible. 

Accord­ing to Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR), an eco­nom­ic oper­a­tor must pre­pare the fol­low­ing details as per sec­tion 1 of part A of annex VI:

• type of eco­nom­ic operator(manufacturer, autho­rised rep­re­sen­ta­tive, or importer, 
• name, address and con­tact details of the eco­nom­ic operator, 
• where sub­mis­sion of infor­ma­tion is car­ried out by anoth­er per­son on behalf of any of the eco­nom­ic oper­a­tors men­tioned under Sec­tion 1.1, the name, address and con­tact details of that person, 
• name address and con­tact details of the per­son or per­sons respon­si­ble for reg­u­la­to­ry com­pli­ance referred to in Arti­cle 15.

Read our full arti­cle “EUDAMED eco­nom­ic oper­a­tor reg­is­tra­tion mod­ule avail­able as of Decem­ber 2020“.

Do you require addi­tion­al details or assis­tance with obtain­ing the SRN? Then please get in touch with our team!

Source: MDCG guid­ance, MDR

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

• Para­graph “Major aspects of the MDR”.
• Arti­cle “Most impor­tant changes on MDR“.
• Arti­cle “Ear­ly access to Sin­gle Reg­is­tra­tion Num­bers (SRN)“.
• Arti­cle “Device Reg­is­tra­tion and Lega­cy Devices“.
• Arti­cle “Updat­ed timetable for EUDAMED“.
• Tag “Guid­ance Doc­u­ments“.