The Med­ical Devices Coor­di­na­tion Group (MDCG) has pub­lished a num­ber of guid­ance doc­u­ments on the top­ic of UDI over the past months. More recent­ly, the MDCG issued guid­ing prin­ci­ples for issu­ing enti­ties, in which it was spec­i­fied that the max­i­mum num­ber of char­ac­ters in the Basic UDI-DI will be lim­it­ed to 25.

More­over, the MDCG announced that a deci­sion has been made with regards to the nomen­cla­ture sys­tem to be used in EUDAMED: Eco­nom­ic Oper­a­tors will have to use the Ital­ian CND nomen­cla­ture, which will be mapped to the GMDN nomenclature. 

Final­ly, the Euro­pean Com­mis­sion adopt­ed an imple­ment­ing act assign­ing the issu­ing enti­ties under the Reg­u­la­tions. Man­u­fac­tur­ers may choose to work with GS1 AISBL, Health Indus­try Busi­ness Com­mu­ni­ca­tions Coun­cil (HIBCC), ICCBBA or Infor­ma­tion­sstelle für Arzneis­pezial­itäten (IFA GmbH).

Should you require more details, please don’t hes­i­tate to get in touch.

Sources: MDCG guidance

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