MDCG 2026-5: UDI assignment between manufacturers and distributors, explained
Only the manufacturer may assign UDIs — the MDCG's answer to distributors obtaining their own UDI-DI codes for rebranded devices.
Some distributors who sell a device under their own brand (while keeping the manufacturer on the label) have been obtaining their own UDI-DI codes from issuing entities. MDCG 2026-5 shuts that down: two trade names may mean two UDI-DIs, but both must be assigned by — and linked to — the manufacturer. A distributor may operate the mechanics under contract, but never in its own name, and only the manufacturer registers the device in EUDAMED.
Who this applies to
Manufacturers whose devices are sold by distributors under a second trade name (with the manufacturer still identified on the label — the Article 16(1)(a) MDR/IVDR arrangement), the distributors in question, and EU UDI issuing entities, who are told to check whom they hand codes to.
The problem the paper addresses
It became common practice for such distributors to request UDI-DI codes from an EU issuing entity in their own name. The result in EUDAMED: one physical device carrying UDI-DIs linked partly to the manufacturer and partly to the distributor. The MDCG's position is that this misreads the regulations:
Allowed |
Not allowed |
|---|---|
Two different UDI-DIs for the same device sold under two trade names |
A distributor obtaining UDI-DI codes from an issuing entity in its own name |
A third party operating UDI assignment on the manufacturer's behalf, under contract |
UDI-DIs linked to anyone but the manufacturer in EUDAMED or issuing-entity records |
The manufacturer registering all UDI-DIs, including for the distributor's brand |
Any economic operator other than the manufacturer registering the device in EUDAMED |
The legal chain is short: a UDI-DI is "specific to a manufacturer and a device" (Article 27(1)(a)(i) MDR / 24(1)(a)(i) IVDR), the manufacturer "shall assign and maintain unique UDIs for its devices" and is the only actor who may place the UDI on the device (Annex VI Part C, 2.2–2.3). Delegating the practical work is fine; the code ownership and the legal liability are not delegable.
What this means for you, practically
- Manufacturers: audit your distribution agreements. Identify any UDI-DI codes held by a rebranding distributor in its own name, stop creating new assignments that way, and agree the remediation with the distributor and issuing entity.
- Register both brands yourself. The UDI-DIs for your own trade name and for the distributor's belong in your EUDAMED registration; the distributor never registers the device.
- Distributors: your own-name UDI codes are the red flag. Acting as the manufacturer's contractor for UDI mechanics is permitted; obtaining codes from an issuing entity as yourself is not — unless you actually take on the manufacturer role, with everything that entails.
- Expect issuing entities to check. The paper instructs EU issuing entities to ensure the entity they link codes to is the party acting as manufacturer.
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