Brussels Says Only Manufacturers May Assign a Device's UDI

A labeling workaround that let distributors put their own identity onto a device's official identifier has run out of road. On 22 July 2026, the Medical Device Coordination Group published MDCG 2026-5 — a position paper on UDI assignment between manufacturers and distributors — concluding that only the manufacturer may assign a device's UDI-DI for the EU market, regardless of whose brand name appears on the box.

The workaround MDCG is closing

The problem MDCG describes is specific and, evidently, common enough to warrant a position paper: a distributor that makes a manufacturer's device available on the EU market under its own brand name has been treating itself as entitled to assign that device's UDI-DI — the identifier that anchors the device's record in EUDAMED and on its label. In the arrangement MDCG describes, the distributor ends up holding an alphanumeric code that is linked both to itself and to the underlying manufacturer's device, even though the manufacturer's own indication stays on the label throughout. Some companies in this chain have treated the arrangement as compliant with the MDR and IVDR. MDCG's position paper says it is not.

What MDCG actually concluded

The position is narrow but firm: UDI-DI assignment for a device placed on the EU market belongs to the manufacturer, full stop. That holds even when a device reaches the market under more than one brand — MDCG confirms a device sold under different brand names can carry different UDI-DIs for each brand, but every one of those identifiers must remain linked back to the manufacturer that assigned it, not to the distributor selling it. Distributors are not cut out of UDI work entirely; they can still support the operational side of UDI activities. What does not move is legal responsibility — that stays with the manufacturer regardless of who does the administrative work of getting a code into EUDAMED.

Why the line matters

• Traceability: the UDI-DI is the anchor for a device's identity across EUDAMED, vigilance reporting, and field safety corrective actions. If a distributor's own-brand code and the manufacturer's code drift apart, tracing a specific device back to its manufacturing record gets harder, not easier.
• Own-brand distribution is common: private-label and rebranded device arrangements are routine in the EU device market, which is exactly why MDCG felt the need to draw the line explicitly rather than leave it to inference from the regulation's general UDI provisions.
• Notified bodies read position papers as the working standard: MDCG guidance is not binding law, but notified bodies and market surveillance authorities apply it as the shared interpretation of MDR and IVDR obligations until something more formal supersedes it.
• Contracts, not just labels, are exposed: distribution and private-label agreements that assumed the distributor could assign and own its UDI-DI now sit on the wrong side of MDCG's reading — a compliance gap that shows up in the contract file before it shows up on the label.

What changes now

MDCG 2026-5 does not rewrite the MDR or IVDR; it interprets an obligation that was always the manufacturer's. What changes is that the interpretation is now explicit and public, which removes the room private-label arrangements had been operating in. Manufacturers and distributors running own-brand device lines in the EU have a position paper to check their UDI assignment practice against — and, where a distributor has been assigning its own UDI-DI, a compliance gap to close before a notified body or market surveillance authority checks it for them.