MDCG 2025-8 pub­lished — Mas­ter UDI-DI for spec­ta­cles and asso­ci­at­ed products

MDCG 2025-8 pro­vides prac­ti­cal guid­ance on imple­ment­ing the Mas­ter UDI-DI for spec­ta­cle frames, spec­ta­cle lens­es and ready-to-wear read­ing spec­ta­cles. Build­ing on the med­ical devices reg­u­la­tion (MDR) and Com­mis­sion Del­e­gat­ed Reg­u­la­tion (EU) 2025/1920, it clar­i­fies assign­ment rules, labelling, EUDAMED reg­is­tra­tion, vig­i­lance report­ing and time­lines. The guid­ance can be found here. 

EU Dig­i­tal Omnibus & Dig­i­tal Omnibus AI

The Com­mis­sion pub­lished two noti­fi­ca­tions on propos­ing a Dig­i­tal Omnibus Reg­u­la­tion (har­mon­is­ing cross-cut­ting dig­i­tal rules: data, cook­ies, cyber­se­cu­ri­ty inci­dent report­ing, eIDAS) and a com­ple­men­tary Dig­i­tal Omnibus AI Reg­u­la­tion (tar­get­ed AI mea­sures to reduce frag­men­ta­tion and align AI oblig­a­tions). Togeth­er they aim to sim­pli­fy com­pli­ance, stream­line report­ing and align AI-spe­cif­ic rules with broad­er dig­i­tal-law reforms — key impli­ca­tions for AI-enabled med­ical devices, cyber­se­cu­ri­ty and reg­u­la­to­ry reporting. 

The noti­fi­ca­tions can be found here (EU Dig­i­tal Omnibus) and here (Dig­i­tal Omnibus AI).

EU AI Act Whistle­blow­er Tool 

The Euro­pean Com­mis­sion has launched on Novem­ber 24, 2025, a secure, encrypt­ed chan­nel to report sus­pect­ed AI Act breach­es direct­ly to the EU AI Office. Avail­able in all EU offi­cial lan­guages, the tool sup­ports con­fi­den­tial or anony­mous report­ing and fol­low-up, help­ing detect vio­la­tions that could endan­ger health, safe­ty or fun­da­men­tal rights. Addi­tion­al infor­ma­tion can be found here.

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website