MDCG 2026-5: UDI assign­ments between man­u­fac­tur­ers and distributors

The Med­ical Device Coor­di­na­tion Group (MDCG) has endorsed a Posi­tion Paper in July 2026 – the aim is to clar­i­fy UDI assign­ment between man­u­fac­tur­ers and dis­trib­u­tors under Reg­u­la­tions (EU) 2017/745 and (EU) 2017/746 (MDR and IVDR).

We sum­ma­rized the key points for man­u­fac­tur­ers in a brief overview:

• A dis­trib­u­tor mar­ket­ing a manufacturer’s device under its own name may not obtain UDI-DIs in its own name from an EU issu­ing entity.
• Two UDI-DIs for two trade names remain accept­able — but both must be assigned by the man­u­fac­tur­er and linked to the man­u­fac­tur­er at the issu­ing entity.
• Only the man­u­fac­tur­er may reg­is­ter the device in Eudamed.
• Prac­ti­cal tasks relat­ed to UDI can be del­e­gat­ed to a third par­ty; the legal lia­bil­i­ty stays with the manufacturer.

If relat­ed sce­nar­ios apply, man­u­fac­tur­ers and dis­trib­u­tors should con­sid­er the pro­vi­sions of the posi­tion paper and imple­ment those. The paper can be down­loaded here. 

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• New har­monised stan­dards for ster­il­iz­ers and hear­ing aids list­ed under the MDR
• EC REP to EU REP: A new sym­bol for Euro­pean Autho­rized Representatives