The Euro­pean Com­mis­sion has announced recent­ly that the EUDAMED UDI/Devices and NBs and Cer­tifi­cates mod­ules are now ready. Specif­i­cal­ly, the UDI/Devices mod­ule is prob­a­bly of inter­est for many man­u­fac­tur­ers as it is the part where man­u­fac­tur­ers will have to reg­is­ter their prod­ucts and the belong­ing UDI codes under Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices or in vit­ro diag­nos­tic med­ical devices (MDR and IVDR) respectively.

Togeth­er with the actor reg­is­tra­tion mod­ule, three out of six parts of EUDAMED are now live. It is expect­ed that the data­base will be ful­ly oper­a­tive in spring 2022.

The Commission’s noti­fi­ca­tion also makes clear that the man­u­fac­tur­ers may start enter­ing data on a vol­un­tary basis. This is in line with arti­cle 123 of the MDR and asso­ci­at­ed guid­ance doc­u­ments. mdi Europa nonethe­less strong­ly rec­om­mends to start work­ing with the new mod­ule and use the time to famil­iar­ize with the new reg­is­tra­tion mechanisms.

We antic­i­pate that local coun­try reg­is­tra­tions and MDD/ IVDD reg­is­tra­tion mech­a­nisms will remain in place as long as the use of the EUDAMED data­base is voluntary.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website