Updat­ed Q&A doc­u­ment on MDR and IVDR UDI require­ments from the Euro­pean Commission

The Euro­pean Com­mis­sion has updat­ed its Q&A doc­u­ment on UDI require­ments under the Med­ical Devices Reg­u­la­tion (MDR) and In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (IVDR). The paper pro­vides answers to basic ques­tions on the UDI sys­tem require­ments under the new Reg­u­la­tions and how those relate to the oblig­a­tions of eco­nom­ic operators.

Source: Euro­pean Commission

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

• Our Com­plete Down­load Section.
• Para­graph “Major aspects of the MDR”.
• Arti­cle “Most impor­tant changes on MDR“.
• Arti­cle Unique Device Iden­ti­fi­ca­tion (UDI) and Reg­u­la­tions (EU) 2017/745 on Med­ical Devices and 2017/746 on In Vit­ro Diagnostics
• Arti­cle Updat­ed timetable for Eudamed