Start­ing May 26, 2025, man­u­fac­tur­ers of class I med­ical devices and Class B and C in vit­ro diag­nos­tic (IVD) med­ical devices must com­ply with the Unique Device Iden­ti­fi­ca­tion (UDI) label­ing require­ments under the EU Med­ical Device Reg­u­la­tion (MDR) and In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (IVDR). More specif­i­cal­ly, by that date the UDI car­ri­er must be reflect­ed on the label of devices.

The UDI sys­tem enhances trace­abil­i­ty, patient safe­ty, and coun­ter­feit pre­ven­tion by assign­ing a unique numer­ic or alphanu­mer­ic code to each device. This code must be dis­played on the device, its pack­ag­ing, or instruc­tions for use, ensur­ing clear iden­ti­fi­ca­tion through­out its lifecycle.

Ear­li­er dead­lines applied to high­er-risk devices, includ­ing class III and implantable devices (May 2021) and class IIa and IIb devices or class D IVD med­ical devices (May 2023). Man­u­fac­tur­ers must ensure com­pli­ance by prop­er­ly affix­ing UDI car­ri­ers and updat­ing their label­ing infor­ma­tion if applicable.

With the dead­line approach­ing, com­pa­nies should review their label­ing process­es to meet reg­u­la­to­ry require­ments and avoid mar­ket disruptions.

Source: MDR, IVDR

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

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