EU UDI helpdesk available

Just recent­ly, the Euro­pean Com­mis­sion launched a new helpdesk web­site for EU UDI relat­ed ques­tions under Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices and in vit­ro diag­nos­tic med­ical devices (MDR and IVDR). 

Vis­i­tors will find a col­lec­tion of asso­ci­at­ed guid­ance doc­u­ments and gen­er­al infor­ma­tion, but they have also the pos­si­bil­i­ty to send a request to the helpdesk.

Accord­ing to the Euro­pean Com­mis­sion, “the helpdesk pro­vides sup­port on UDI assign­ment, labelling and reg­is­tra­tion of devices. It also pro­vides sup­port on the use of the Euro­pean Med­ical Devices Nomen­cla­ture (EMDN), which the Euro­pean Com­mis­sion has made avail­able to man­u­fac­tur­ers and oth­er nat­ur­al or legal per­sons required by the MDR and IVDR to use it.” (Euro­pean Commission)

Source: Euro­pean Commission

For fur­ther in depth infor­ma­tion on this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• Arti­cle “Updat­ed Q&A doc­u­ment on MDR and IVDR UDI require­ments from the Euro­pean Commission”
• Arti­cle “Unique Device Iden­ti­fi­ca­tion (UDI) and Reg­u­la­tions (EU) 2017/745 on Med­ical Devices and 2017/746 on In Vit­ro Diag­nos­tics“