Back­ground:
Endorsed by the Med­ical Device Coor­di­na­tion Group (MDCG) in August 26, 2025, MDCG 2024-14 Rev. 1 offers prac­ti­cal guid­ance for imple­ment­ing the “Mas­ter UDI-DI” solu­tion for con­tact lens­es under the EU Med­ical Devices Reg­u­la­tion (MDR).

Pur­pose:
This doc­u­ment helps man­u­fac­tur­ers nav­i­gate the Mas­ter UDI-DI frame­work by clar­i­fy­ing assign­ment rules, label­ing require­ments, and links to Com­mis­sion Del­e­gat­ed Reg­u­la­tion (EU) 2025/788 and con­sol­i­dat­ed MDR texts.

You may access the doc­u­ment and down­load it from our website.

Source: MDCG

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website