What MDCG 2026-5 Says
In July 2026 the Medical Device Coordination Group published MDCG 2026-5, a position paper on UDI assignment between manufacturers and distributors. It addresses a specific practice: some companies have treated it as compliant with MDR/IVDRfor a distributor to obtain its own UDI-DI and register a device in EUDAMED under its own brand, while the original manufacturer's name stays on the label.
MDCG 2026-5 closes that reading. The manufacturer identified on the label and in the device documentation is the only entity that can assign UDIs to a device placed on the EU market, the only entity that can receive codes from the UDI issuing entities on the device's behalf, and the only entity that can register the device in EUDAMED.
The Private-Label Setup
The arrangement MDCG 2026-5 addresses is built on MDR Article 16(1)(a) / IVDR Article 16(1)(a). Article 16(1) generally treats a distributor that makes a device available under its own name, registered trade name, or registered trademark as taking on manufacturer obligations. Point (a) carves out an exception: where a distributor or importer enters into an agreement with the manufacturer under which the manufacturer is still identified as such on the label, the distributor does not take on those obligations.
In practice this lets a distributor put its own brand on a device's outer packaging or marketing material while the manufacturer's name remains on the label as required. It is a common structure for private-label medical devices and store-brand IVDs sold through a distributor's existing channel.
The question MDCG 2026-5 answers is what happens to UDI assignment and EUDAMED registration inside that structure, since neither the MDR/IVDR text nor earlier UDI guidance addressed it directly.
Why Only the Manufacturer
The UDI system under MDR Article 27(1) and IVDR Article 24(1)defines the UDI-DI as a device identifier "specific to a manufacturer and a device." The identifier is structurally tied to the manufacturer from the point of assignment; it is not a generic product code that any party in the supply chain can request independently.
MDCG 2026-5's conclusion follows directly from that structure. Because an Article 16(1)(a) agreement leaves the manufacturer identified on the label, and because a UDI-DI is defined as manufacturer-specific, a distributor operating under that agreement has no independent basis to obtain a UDI-DI or an EUDAMED device registration in its own right. The manufacturer named on the label is the entity the UDI-DI and the EUDAMED record must point to.
What This Means in Practice
For manufacturers and distributors already operating under an Article 16(1)(a) agreement, MDCG 2026-5 does not require restructuring the commercial relationship. It requires making sure the regulatory paperwork matches who the guidance says is responsible.
| Task | Who Is Responsible | Notes |
|---|---|---|
| Assigning the UDI-DI | Manufacturer | Requested from the issuing entity (GS1, HIBCC, ICCBBA, or IFA) under the manufacturer's account, not the distributor's. |
| Registering the device in EUDAMED | Manufacturer | The device record is submitted under the manufacturer's actor registration (SRN), regardless of which brand appears on distributor-facing packaging. |
| Distributor brand on packaging/marketing | Distributor, by agreement | Permitted under Article 16(1)(a) as long as the manufacturer remains identified on the label itself. |
| Operational data entry for UDI/EUDAMED tasks | Can be delegated to the distributor | Delegation is allowed for the administrative work; legal responsibility and the UDI-manufacturer link cannot be delegated away. |
If a distributor has been assigning its own UDI-DI under an existing private-label agreement, MDCG 2026-5 is the signal to review that setup against Article 16(1)(a) and correct the UDI-DI and EUDAMED record so both trace to the manufacturer before the next registration cycle or notified body review.
Common Mistakes
| Mistake | What Goes Wrong | Correct Approach |
|---|---|---|
| Distributor requests its own UDI-DI for a private-labeled device | Creates a UDI-DI not linked to the manufacturer identified on the label; MDCG 2026-5 treats this as non-compliant even where an Article 16(1)(a) agreement exists | The manufacturer requests and holds the UDI-DI; the distributor's brand appears only on packaging or marketing, not the UDI-DI record. |
| Assuming the Article 16(1)(a) agreement transfers EUDAMED registration duties | The agreement covers labeling and brand use, not UDI or EUDAMED registration responsibility | Read Article 16(1)(a) narrowly: it is an exception to when a distributor takes on manufacturer obligations generally, not a reassignment of UDI/EUDAMED duties specifically. |
| Treating operational delegation as legal delegation | A distributor entering data on the manufacturer's behalf is fine; a distributor being the entity of record in EUDAMED is not | Keep the manufacturer as the actor of record for the device registration, even where a distributor performs the data entry under contract. |
MDCG 2026-5 does not change what data belongs in a EUDAMED device record. It changes, or rather clarifies, who is allowed to be the entity submitting it. For manufacturers running private-label or distributor-branded lines, that is worth confirming now rather than discovering during a notified body review.
Frequently Asked Questions
What does MDCG 2026-5 say about UDI-DI assignment?
MDCG 2026-5, published in July 2026, states that the manufacturer, as indicated on the label of the device and the device documentation, is the only entity which can assign UDIs to a device intended to be placed on the EU market, receive codes from the UDI issuing entities, and register the device in EUDAMED.
Can a distributor register a device in EUDAMED under its own brand?
No. Under Article 16(1)(a) MDR and IVDR, a distributor can make a device available under its own name or trademark while the manufacturer remains identified on the label. MDCG 2026-5 clarifies that this arrangement does not transfer UDI-DI assignment or EUDAMED registration to the distributor. Those stay with the manufacturer.
Does an Article 16(1)(a) agreement change who the legal manufacturer is?
No. Article 16(1)(a) is worded as an exception to the general rule in Article 16(1) that a distributor marketing a device under its own name takes on manufacturer obligations. Where the manufacturer stays identified on the label under a signed agreement, the distributor does not become the manufacturer for regulatory purposes, and MDCG 2026-5 confirms UDI and EUDAMED obligations follow accordingly.
What happens if a distributor already obtained its own UDI-DI for a private-labeled device?
MDCG 2026-5 does not itself impose a retroactive penalty; it states the compliant position going forward. A manufacturer or distributor in this situation should review the arrangement against Article 16(1)(a) and correct the UDI-DI and EUDAMED registration so both trace to the manufacturer, since a device with two independently issued UDI-DIs for the same physical product creates a duplicate-registration and traceability problem in EUDAMED.
Can a manufacturer delegate the operational work of UDI assignment to a distributor?
Yes, as an operational matter manufacturers can contract out tasks like data entry. What cannot be delegated is the legal assignment: the UDI-DI must be linked to the manufacturer in the issuing entity's database and in EUDAMED, and the manufacturer retains responsibility for correctness.
Is MDCG 2026-5 legally binding?
No. MDCG guidance documents are not legally binding, but competent authorities and notified bodies treat them as the interpretive standard for MDR and IVDR. MDCG 2026-5 does not create a new legal requirement; it clarifies how the existing Article 16(1)(a), Article 27 (MDR) and Article 24 (IVDR) UDI provisions apply to private-label arrangements.