Confirmed! Distributors Are No Longer Allowed to Apply for UDI-DI Independently - Wiselink Group-A More Controllable, Stable, and Future-Oriented Material Direction

Home > News Center > Confirmed! Distributors Are No Longer Allowed to Apply for UDI-DI Independently

Confirmed! Distributors Are No Longer Allowed to Apply for UDI-DI Independently

Time：2026-08-05 13:53:02

The Medical Device Coordination Group (MDCG) has officially released Position Paper MDCG 2026-5, delivering a definitive ruling on the long-standing industry dispute over whether distributors may independently assign UDI-DIs. The document clearly delineates the statutory division of responsibilities between manufacturers and distributors under the UDI system.

原

文

链

接

https://health.ec.europa.eu/document/download/f34c1afd-8d01-44cc-bf94-33e4bcac0ef2_en?filename=mdcg_2026-5_en.pdf

一、Long-standing Industry Dispute

A common business model prevails in the EU medical device market: distributors sign agreements with manufacturers to place devices on the EU market under their own brand names, while retaining the original manufacturer’s information on product labels.

Under this model, many distributors directly apply to EU UDI issuing entities for UDI-DI codes registered under their own legal entities, linking the codes to both the distributor and the manufactured device. Manufacturers then register two sets of UDI-DIs under one Basic UDI-DI in Eudamed:

UDI-DIs assigned by the manufacturer for products sold under its own brand;
UDI-DIs obtained by distributors for the identical devices marketed under the distributors’ private labels.

This practice results in one single medical device being associated with multiple UDI-DIs tied to different legal entities within the Eudamed database.Many companies have assumed that separate UDI-DIs for different trade names comply with regulatory rules, even citing Article 16(1)(a) of MDR/IVDR to argue that distributors may take full charge of UDI assignment. This widespread misinterpretation is the core misconception addressed and corrected in the new MDCG position paper.

二、Clear Official Ruling

The document grounds its conclusions in core provisions of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), establishing manufacturers as the sole legally responsible party for all UDI system obligations:

MDR Article 10(7), Article 27 and corresponding IVDR clauses impose full UDI compliance duties on manufacturers.
Annex VI Part C of both regulations explicitly states two binding requirements:
1. Only manufacturers shall assign and maintain unique UDIs for their devices;
2. Only manufacturers may affix UDIs onto devices or their packaging.

From this regulatory foundation, MDCG lays out four definitive conclusions:

（一）Multiple UDI-DIs for multi-brand products are permitted, yet assignment is exclusive to manufacturers

One medical device sold under multiple brands (manufacturer’s original brand or distributor private label) may carry distinct UDI-DIs. However, every UDI-DI must be assigned solely by the manufacturer; distributors have no authority to independently obtain or allocate UDI-DIs under their own entity names.

（二）All UDI-DIs must be linked to the manufacturer

All UDI-DIs — whether for the manufacturer’s own brand or the distributor’s private label versions — shall be associated exclusively with the manufacturer’s legal identity in two key systems:

Databases operated by EU UDI issuing entities;
The UDI/device registration module within Eudamed.Separate linking to both manufacturer and distributor entities is prohibited.

（三）Third-party delegation of operational tasks is allowed, yet legal liability remains with the manufacturer

Manufacturers may contract third parties (including distributors or authorised representatives) to conduct practical UDI work such as code applications and label affixing. Regardless of delegation arrangements, the manufacturer retains ultimate legal accountability for all UDI regulatory compliance. This aligns fully with official guidance published by the EU UDI Helpdesk.

（四）UDI issuing entities shall refuse UDI-DI issuance to distributors

EU UDI issuing bodies are instructed to verify that all applicants for UDI-DIs qualify as legal manufacturers per EU regulations before releasing codes and completing entity linkage. They must decline applications submitted by distributors, importers or other economic operators acting without manufacturer authorisation.

三、Compliance Remedial Actions for Industry Players

This position paper tightens the accountability framework of the EU UDI system, reiterating manufacturers as the primary liable party. Below are targeted compliance recommendations for manufacturers and distributors respectively.

（一）For Manufacturers

Review all existing distributor partnerships, especially private label arrangements. Identify cases where distributors independently applied for UDI-DIs and implement rectification promptly: all relevant UDI-DIs must be reassigned and registered in Eudamed directly by the manufacturer.
Clarify UDI rights and obligations within distribution contracts: manufacturers shall oversee all UDI applications, ongoing maintenance and Eudamed registrations. Distributors may only support execution-level tasks and are forbidden from submitting independent UDI-DI applications to issuing entities.
Rectify Eudamed registration data: ensure all UDI-DIs corresponding to different trade names of the same device are listed under one Basic UDI-DI belonging to the manufacturer, with consistent manufacturer entity information across all entries.

（二）For Distributors

Cease all independent UDI-DI applications to EU UDI issuing entities immediately. For codes already obtained under your distributor entity, negotiate with upstream manufacturers to complete entity re-linkage or cancel and reissue compliant codes.
Establish formal UDI workflows with your manufacturers to receive brand-specific UDI-DIs directly from them, eliminating regulatory risks arising from mismatched legal entity records.

四、Closing Remarks

MDCG 2026-5 reinforces consistency and transparency across the EU UDI regulatory landscape and draws a clear compliance red line for market operators. For medical device companies exporting to the EU, the UDI system forms a foundational compliance requirement covering the entire product lifecycle. Timely review, adjustment and standardisation of your UDI allocation procedures are critical to avoiding non-compliance penalties during future authority inspections.For further professional consultation, contact Wiselink.

Previous：FDA Human Factors Guidance Updated: Review Standards Become Stricter & More Unified Next：Hong Kong’s Medical Device Regulation Gets Major Upgrade: Clearer, More Granular Market Access Requirements

Fill Form

Whether you need more information or wish to cooperate with us, we will guide you through every step of the regulatory process. Subscribe to our newsletter for the latest global regulatory updates.