New MDCG guid­ance doc­u­ment maps IMDRF UDI prin­ci­ples with MDR and IVDR

The Med­ical Device Coor­di­na­tion Group (MDCG) has issued anoth­er guid­ance doc­u­ment. MDCG 2021-10 ref­er­ences cer­tain prin­ci­ples and ter­mi­nol­o­gy used in appen­dices E – I of the IMDRF N48 guid­ance doc­u­ment on Unique Device Iden­ti­fi­ca­tion (UDI) systems.

The doc­u­ment states that there are prin­ci­ples and ter­mi­nol­o­gy that are not ful­ly aligned with Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices and in vit­ro diag­nos­tic med­ical devices (MDR and IVDR). MDCG 2021-10 intends to pro­vide clar­i­ty in that regard and includes a use­ful table that maps the con­cerned prin­ci­ples and terms.

Should you require the doc­u­ment, please don’t hes­i­tate to get in touch. 

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

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