EU MDCG 2026-5 Clarifies UDI Assignment Responsibility: Distributor Own-Brand UDI-DIs Must Remain Under the Manufacturer

The European Commission's Medical Device Coordination Group (MDCG) published position paper MDCG 2026-5 in July 2026 to clarify a long-standing but inconsistently understood practice: distributors applying for a UDI-DI in their own name when placing devices on the EU market under their own brand. The paper confirms that two UDI-DIs may exist for the same device sold under two trade names, but both must be assigned by the manufacturer and linked to the manufacturer both in EUDAMED and at the UDI issuing entity. A third party may carry out the operational steps, but legal responsibility cannot be transferred.

What happened

In July 2026, the MDCG published the position paper MDCG 2026-5, "UDI assignment between manufacturers and distributors". The document runs to only three pages and addresses a practice that has long existed on the EU market but has been subject to diverging interpretations: distributors selling devices under their own brand applying directly to a UDI issuing entity for a UDI-DI and registering the code in their own name.

The MDCG's conclusion is direct: where the same device is placed on the market under two different trade names, it may indeed correspond to two different UDI-DIs. However, both UDI-DIs must be held under the manufacturer's name, not the distributor's. This must be consistent in the UDI/Device registration module of EUDAMED and in the database or internal records of the UDI issuing entity.

The purpose of the clarification is stated at the outset of the paper: to avoid confusion, misunderstanding or abuse arising from divergent interpretations among manufacturers, distributors and issuing entities, and to ensure a consistent approach across Member States when applying the UDI provisions and operating EUDAMED.

Legal basis

The rules cited in the document are not new; previously they had simply not been set out in a position paper with a clear scope of application.

• MDR (Regulation (EU) 2017/745): Article 10(7) requires manufacturers to comply with the UDI system obligations under Article 27 and the registration obligations under Articles 29 and 31; Article 27(1)(a)(i) provides that a UDI-DI is specific to a manufacturer and a device; Annex VI, Part C, point 2.2 states that the manufacturer shall assign and maintain a unique UDI for its devices, and point 2.3 states that only the manufacturer may place the UDI on the device or its packaging.
• IVDR (Regulation (EU) 2017/746): the corresponding provisions are Article 10(6), Article 24(1)(a)(i) and Annex VI, Part C.

The practice corrected

The MDCG describes a situation in which some companies consider it compliant with the MDR/IVDR for a distributor to assign the UDI, based on an agreement with the manufacturer (an arrangement permitted under Article 16(1)(a) of the MDR/IVDR, whereby the distributor places the device on the EU market under its own name while retaining the manufacturer's information on the label).

Under this practice, the distributor obtains an alphanumeric code from an EU UDI issuing entity, and the UDI-DI is bound to the distributor and to the device produced by the manufacturer. Under the same Basic UDI-DI, the manufacturer lists and registers two sets of UDI-DIs in EUDAMED: one assigned by the manufacturer, and another assigned by the distributor. The same device therefore appears in EUDAMED with UDI-DIs originating from different entities.

The MDCG considers this to be incorrect.

Conclusion and responsibility boundary

The "Discussion and conclusion" section of the paper states that assigning two different UDI-DI codes to the same device is not in itself a problem, but the assignment may only be performed by the manufacturer. EU UDI issuing entities should ensure that the entity to which they provide and link UDI-DI codes is the company acting as the manufacturer.

At the same time, the paper leaves room for operational flexibility: it does not preclude a third party other than the manufacturer from liaising with the issuing entity on the manufacturer's behalf. According to the EU UDI Helpdesk, the MDR/IVDR only designate the legal entity that bears the UDI obligations; they do not regulate arrangements under which other parties carry out UDI application and assignment activities on that entity's behalf. In principle, a manufacturer may delegate the practical work of UDI assignment and application to a third party (for example, by contract), but the ultimate legal responsibility for complying with the UDI obligations remains with the manufacturer.

The MDCG further clarifies that the provisions of the MDR/IVDR and the explanations of the UDI Helpdesk should not be interpreted as authorising authorised representatives, distributors, importers or other economic operators to assign a UDI to a device. The manufacturer identified on the label and in the device documentation is the only entity that may assign a UDI to a device intended for the EU market and obtain the associated codes from a UDI issuing entity, and the only entity that may register that device in EUDAMED.

Scope of application

The nature of the document itself should be noted: MDCG 2026-5 is an MDCG position paper, and its header states that it is not a European Commission document, does not represent the official position of the European Commission, and that the views it contains are not legally binding; binding interpretation of EU law is a matter for the Court of Justice of the European Union alone.

The document does not set a new compliance deadline and does not list exemptions or transition periods; it clarifies how the existing provisions should be understood and applied.

Sources

• European Commission / Medical Device Coordination Group (MDCG), position paper MDCG 2026-5, "UDI assignment between manufacturers and distributors", marked July 2026, European Commission publication date 22 July 2026: https://health.ec.europa.eu/document/download/f34c1afd-8d01-44cc-bf94-33e4bcac0ef2_en?filename=mdcg_2026-5_en.pdf
• European Commission, MDCG endorsed documents and other guidance (which lists MDCG 2026-5, Publication: July 2026): https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
• EU UDI Helpdesk, UDI assignment obligations: https://webgate.ec.europa.eu/udi-helpdesk/en/udi-assignment/obligations.html

Verification scope and access date: the pages above were accessed on 28 September 2026, and the MDR Articles 10(7) and 27(1)(a)(i), Annex VI Part C points 2.2 and 2.3, IVDR Articles 10(6) and 24(1)(a)(i), and the wording of the "Discussion and conclusion" section of MDCG 2026-5 were checked against the original text.

Applicability note: this article is an interpretation of publicly available regulatory information and does not constitute a conclusion or commitment regarding any specific product, company or registration application. The document is a position paper and is not legally binding; for specific application, the official texts of the MDR/IVDR prevail, and the information may change with subsequent official updates.

AIMEILI regulatory interpretation

Direct impact on Chinese device manufacturers

If a company acts as an OEM/ODM manufacturer for EU distributors, or sells in the EU under a distributor's own brand, this document speaks directly to its UDI process. The common past practice was to let the distributor apply for the UDI-DI, because whoever holds the code in the system appears to be the party owning the device. MDCG 2026-5 tightens this route: there may be two brands, but there can be only one owner of the UDI-DI, namely the manufacturer named on the label.

The practical significance for Chinese manufacturers is that many products exported to the EU go through multi-brand distribution: the same device is sold under the manufacturer's own trademark and under a second trademark held by an EU local partner. In such structures, if code ownership is not properly aligned, a competent authority checking EUDAMED could see a distributor holding the UDI-DI while the label names a Chinese manufacturer; the two do not match, which can trigger requests for explanation or corrective action. Resolving this mismatch is precisely what the document is intended to achieve.

What to check now

• Review agreements with EU distributors and importers, especially arrangements under Article 16(1)(a) where the device is placed on the market under the distributor's name while the manufacturer's information is retained on the label, and confirm in whose name UDI assignment and application are recorded.
• Log into the UDI/Device module of EUDAMED and check whether UDI-DIs assigned by a distributor and registered under a distributor as the registering entity have been mixed into the Basic UDI-DI of your devices.
• Check with the UDI issuing entity you use whether the entity owning the UDI-DI in its records is the manufacturer. The number of recognised EU UDI issuing entities is limited, so confirming ownership entity by entity is more cost-effective than correcting the position after the event.
• Write these three points into the quality system documentation and the annual UDI review process, so that the old practice is not reintroduced at the next certificate update or when a distributor changes brand. For companies with multiple EU distributors, check distributor by distributor rather than by sampling.

Three common misconceptions

• First, that an Article 16(1)(a) agreement makes everything compliant. Such an agreement determines who places the device on the market; it does not change the legal entity that bears the UDI obligations.
• Second, that a code applied for by the distributor means the distributor bears responsibility if something goes wrong. The MDCG and the EU UDI Helpdesk take the same position: operational tasks may be delegated to a third party, but the ultimate legal responsibility remains with the manufacturer.
• Third, that having both sets of UDI-DIs registered is correct. The MDCG accepts that the same device may have two UDI-DIs, but only on the basis that both are assigned by the manufacturer and linked to the manufacturer in both EUDAMED and the issuing entity's records.

Applicability and timing

MDCG 2026-5 is a position paper; it is not legally binding and does not set a uniform deadline for corrective action. It changes the interpretative position and the consistency of enforcement rather than adding a new quantifiable reporting requirement, and the enforcement pace of Member State competent authorities may vary.

The header of the document also states that it does not represent the official position of the European Commission and that binding interpretation of EU law rests solely with the Court of Justice of the European Union. It is therefore better understood as an explanatory statement of the enforcement position than as a dated corrective action notice.

For companies, the more realistic approach is to treat it as a trigger for an internal review: first assess the current position, then decide whether coordination with distributors and issuing entities is needed to reassign codes or correct EUDAMED records. Whether a change is needed, and how extensive it must be, depends on the actual distribution structure and registration route; it must be checked product by product and cannot be generalised. If IVD products are also involved, IVDR Articles 10(6) and 24(1)(a)(i) should be included in the same review.

What companies should check

Priority should be given to the intended purpose, the basis for classification, ISO 13485 quality system evidence, risk management documentation, performance verification data, clinical evaluation or clinical evidence, labels and instructions for use, authorisation documents and existing registration certificates.

Common risks

Common risks include unclear classification decisions, an incomplete evidence chain, non-localised labels and instructions for use, unclear responsibilities of the authorised representative, and inadequate post-market maintenance arrangements.

FAQ

Can MDCG 2026-5 be used directly as a basis for a regulatory submission?

No. This article is intended for preliminary understanding and project assessment; a formal submission must still be based on the latest requirements of the target country's regulatory authority, the product classification conclusion and the company's actual documentation. A position paper such as MDCG 2026-5 explains how existing provisions should be understood and applied, but it does not replace the official legal requirements, conformity assessment outcomes or legal advice.

What should a company do first when it sees an update of this kind?

Start with a documentation gap assessment to determine whether the update affects the registration route, technical documentation, labelling, the quality system or post-market maintenance. Where the update concerns UDI assignment, the first step is to compare the manufacturer named in EUDAMED and in the UDI issuing entity's records with the manufacturer named on the label and in the distributor agreements.

Content review and applicability

Content author: AIMEILI Regulatory Editorial Team. Professional review: AIMEILI International Medical Device Registration Project Team.

Source principles: official regulatory authorities, international organisations, standards bodies and publicly available regulatory materials are prioritised; industry media and project experience are used only as supporting judgement.

Applicability: this article is intended for preliminary understanding, documentation preparation and project planning, and does not replace the formal requirements of the target country's regulatory authority, testing conclusions or legal advice.