In July 2025, the Med­ical Device Coor­di­na­tion Group (MDCG) endorsed MDCG 2025-7, a posi­tion paper under Arti­cle 103 of the MDR (Reg­u­la­tion EU 2017/745). This fol­lows the EU’s rolling imple­men­ta­tion of its Unique Device Iden­ti­fi­ca­tion (UDI) sys­tem and builds on ear­li­er guid­ance on UDI-DI requirements.

Pur­pose

MDCG 2025-7 defines clear time­lines for assign­ing the ‘Mas­ter UDI-DI’ to spe­cif­ic opti­cal devices—contact lens­es, spec­ta­cle frames, spec­ta­cle lens­es, and ready-to-wear read­ing spec­ta­cles. By lay­ing out phased dates for com­pli­ance, the paper helps man­u­fac­tur­ers, importers, and noti­fied bod­ies pre­pare labelling, data sub­mis­sion to EUDAMED, and sup­ply-chain track­ing. Its goal is to ensure har­monised UDI roll­out, improve device trace­abil­i­ty, and bol­ster patient safe­ty across the EU opti­cal device sector. 

As quot­ed from the doc­u­ment, the cor­re­spond­ing time­lines are described as follows

Appli­ca­tion of UDI labelling requirements:

As estab­lished in Arti­cle 123(3)(f) of the MDR, the pro­vi­sions of Arti­cle 27(4) on the place­ment of UDI car­ri­ers on the label of the device and on all high­er lev­els of pack­ag­ing apply for class­es IIa and IIb devices from 26 May 2023, while for class I devices they apply from 26 May 2025.

Manda­to­ry use of the UDI/Device reg­is­tra­tion mod­ule in Eudamed:

As estab­lished in Arti­cle 29 and in Arti­cle 123 of the MDR, as amend­ed by Reg­u­la­tion (EU) 2024/1860, and accord­ing to the lat­est avail­able Eudamed time­line, the use of the UDI/Device reg­is­tra­tion mod­ule of Eudamed should become manda­to­ry to use as from the first quar­ter (Q1) of 2026, it is to say, 6 months after the pub­li­ca­tion in the Offi­cial Jour­nal of the Euro­pean Union (OJEU) of the notice con­firm­ing the func­tion­al­i­ty of that module. 

Imple­men­ta­tion of Mas­ter UDI-DI to con­tact lenses:

As estab­lished in Com­mis­sion Del­e­gat­ed Reg­u­la­tion (EU) 2023/2197 of 10 July 2023, as amend­ed, the Mas­ter UDI-DI solu­tion must be imple­ment­ed by man­u­fac­tur­ers of con­tact lens­es as from 9 Novem­ber 2026, three years after the enter­ing into force of the act. Con­tact lens­es pro­duced pri­or to 9 Novem­ber 2026 are not required to have a Mas­ter UDI-DI on the label. 

Imple­men­ta­tion of Mas­ter UDI-DI to spec­ta­cle frames, spec­ta­cle lens­es and ready­to-wear read­ing spectacles:

As estab­lished in Com­mis­sion Del­e­gat­ed Reg­u­la­tion of 12 June 2025, the Mas­ter UDI-DI solu­tion must be imple­ment­ed by man­u­fac­tur­ers of spec­ta­cle frames, spec­ta­cle lens­es and ready-to-wear read­ing spec­ta­cles as from Sep­tem­ber 2028, three years after the enter­ing into force of the act.

Man­u­fac­tur­ers with the cor­re­spond­ing prod­uct range are invit­ed to con­sid­er the pro­vi­sions in the doc­u­ment. The doc­u­ment can be down­loaded from our web­site.

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website