Anna Sahlholm
Consultant manager, GBA Key2Compliance
When the same medical device is sold under different trade names, it may seem logical for each brand owner to obtain its own UDI-DI. Under the EU MDR and IVDR, however, the decisive question is not who owns the brand, but who acts as the legal manufacturer.
MDCG 2026-5 addresses arrangements in which a distributor markets a device under its own trade name while the legal manufacturer remains identified as the manufacturer on the label.
The conclusion is clear: differently branded versions may have different UDI-DIs, but the identifiers must be assigned by, and linked to, the legal manufacturer.
For companies using own-brand or private-label distribution models, this is a good reason to review existing UDI records, agreements and post-market data flows.
What does MDCG 2026-5 clarify?
Under both the MDR and IVDR, the UDI-DI is specific to a legal manufacturer and a device. The legal manufacturer is responsible for assigning and maintaining the UDI and for registering the device in EUDAMED.
MDCG 2026-5 considers a situation where:
- a legal manufacturer places a device on the EU market;
- a distributor sells the device under another trade name;
- the legal manufacturer remains identified on the label; and
- the distributor does not assume the role of manufacturer.
In this situation, the differently branded products may have separate UDI-DIs. However, all identifiers must be assigned by and linked to the legal manufacturer—not separately to the legal manufacturer and distributor.
Read the MDCG Position Paper here:
MDCG 2026-5: UDI assignment between manufacturers and distributors
Administration can be delegated, responsibility cannot
A legal manufacturer may ask a distributor or service provider to perform administrative tasks, such as communicating with a UDI issuing entity or supporting the application process. This does not transfer the regulatory responsibility for assigning the UDI.
Quality and distribution agreements should therefore make clear the authorities set for the distributor.
Clinical and post-market implications
When one device is sold under several trade names, commercial branding should not fragment the clinical and post-market picture.
The manufacturer needs to be able to:
- consolidate complaints and vigilance data across trade names;
- trace every marketed version to the correct manufacturer and device;
- identify signals linked to a specific brand, market or distributor;
- maintain consistent intended purposes, claims and instructions; and
- connect each version to the relevant clinical evaluation, risk-management file and PMS plan.
This does not mean that differently branded versions can automatically be treated as clinically identical. Differences in claims, intended purpose, users, instructions or configuration still need to be assessed.
The objective is traceability in both directions: from each branded product to its supporting evidence and from every safety signal to all affected marketed versions.
Five checks to perform now
- Map own-brand arrangements List all devices sold under alternative trade names, including distributors, markets, catalogue numbers, Basic UDI-DIs and UDI-DIs.
- Confirm the legal manufacturer Verify which entity is identified as the legal manufacturer on the label and whether any distributor or importer has assumed manufacturer obligations under Article 16 MDR or IVDR. Commercial terms such as “private label”, “brand owner” and “OEM” do not determine the regulatory role.
- Review UDI records Check whether each UDI-DI is linked to the correct manufacturer in both the issuing entity’s records and EUDAMED. Pay particular attention to identifiers obtained directly by distributors.
- Reconcile controlled information Compare the UDI records with labels, declarations of conformity, technical documentation, certificates, PMS documents and internal product-master data. Any discrepancy should be documented and assessed for its effects on compliance and traceability.
- Clarify responsibilities Update quality or distribution agreements where necessary. The agreements should cover UDI administration, EUDAMED registration, change communication, data verification and the exchange of complaint and vigilance information. If an identifier is linked to the wrong actor, treat the correction through appropriate change-control and CAPA processes rather than as a simple administrative update.
A useful audit question
For every UDI-DI associated with one of your devices, can you demonstrate who assigned it, which manufacturer it is linked to, where it is registered and how the related PMS data reach the legal manufacturer?
If the answer depends on informal explanations or undocumented assumptions, the organisation may have a data-governance problem as well as a UDI problem.
Conclusion
MDCG 2026-5 does not prohibit different UDI-DIs for the same device sold under different trade names. It clarifies that those identifiers must originate from and remain linked to the legal manufacturer.
Legal manufacturers and distributors should use this clarification to review their UDI records, contractual responsibilities and post-market data flows. The goal is not merely correct registration—it is a consistent and traceable regulatory identity throughout the device lifecycle.
Need support with UDI or own-brand arrangements?
If you are unsure whether your UDI setup, responsibilities or post-market data flows are aligned with the latest guidance, our medical device experts can help you review your current arrangements and identify any gaps.
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