Unique Device Identifier Deployment: Role and Challenges in Traceability and Expedited Device Approvals Across the European Union and United States

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Technical Review Article | Open Access | Published 2 July 2026

Unique Device Identifier Deployment: Role and Challenges in Traceability and Expedited Device Approvals Across the European Union and United States

Divyasree Baraneetharan, M Pharm¹*, Dr. Shivanand K Mutta, M Pharm, Ph D² | EJPPS | 312 (2026) https://doi.org/10.37521/ejpps31209

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Abstract

Unique Device Identifier (UDI) system has become an important regulation instrument in enhancing medical devices traceability and post-market supervision in the European Union (EU) and the United States (US). UDI systems enhance patient safety, efficiency of recall, and facilitate creation of real-world evidence to make regulatory decisions by allocating standardized identifiers and connecting these identifiers with centralized databases on devices. This review will summarize regulatory requirements and implementation experience of UDI under the European medical device regulations and the United States Food and Drug Administration UDI rule, and highlight the supply-chain transparency, lifecycle monitoring as well as a possible way of enabling expedited approvals of devices. Although these regulations have been made, there exist numerous obstacles which prevent an effective implementation, such as old information technology infrastructure, poor data quality, lack of complete integration with clinical and administrative systems, inconsistent adoption of standards, and delays in the full operationalization of databases. These issues limit the achievement of UDI advantages of surveillance and regulatory dependence. The review presents feasible measures in implementing stage-by-stage, better governance, and coordination of cross-stakeholders to effectively utilize UDI in traceability, post-market surveillance, and evidence-based regulatory directions in interjurisdiction.

Keywords: Medical Device Traceability, Post-market Surveillance, Real-world Evidence, Regulatory Science, Unique Device Identifier.

Introduction

The Unique Device Identifier (UDI) program is a significant development in the regulation of medical devices, which allows us to identify the devices in the entire life cycle in a standard manner and enhance the safety monitoring and traceability. The UDI System was developed in the United States by the U.S. Food and Drug Administration (FDA) to assist with the post-market monitoring modernization, improve the recalls of devices, and incorporate the device identifiers into the electronic health records and supply-chain processes ¹. At the same time, the European Union introduced unique device identification (UDI) requirements under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), with the assistance of which device data is centrally stored in the European Database on Medical Devices (EUDAMED) to increase the level of transparency, monitoring, and harmonized monitoring throughout Member States ².

A winning implementation of UDI is essential in enhancing the generation of real-world evidence (RWE). The efforts by U.S. to develop two systems like the National Evaluation System for Health Technology (NEST) have proved UDI capture within clinical systems can create linkages between devices, outcomes, and patient characteristics to provide opportunities to identify safety signals, enhance quality, and generate regulatory evidence ³. Early FDA demonstration projects have also demonstrated that UDIs can be incorporated throughout provider workflows and hospital information systems, but several structural and operational issues are still present ⁴. The results are supported by more extensive studies that emphasized that UDI is associated with the enhancing of patient safety, recall responsiveness, and all-inclusive post-market surveillance systems ⁵.

Recent regulatory changes in Europe focus on how UDI can be used to enhance the strength of device traceability, harmonize surveillance frameworks, and coordinate EU-level oversight under MDR/IVDR ⁶. The experiences that were described in France, and others that are country specific, demonstrate the practical dimensions of implementing UDI, including the readiness of the national system, stakeholder involvement, and alignment with capabilities of the manufacturers ⁷. In addition to regulatory regulation, harmonized nomenclature standards such as GMDN and SNOMED CT are important in facilitating semantic consistency in EUDAMED and across the rest of the world databases, facilitating proper classification of devices and interaction ⁸.

To demonstrate that the system is usable everywhere, it has been supported by some projects such as BUILD in a large number of institutions that UDI is applicable in long-term clinical data networks. They demonstrate that a method of linking data with identifiers could assist in generating high-quality real-world information to regulators and clinical decision makers ⁹. These moves are in line with general studies that explain how to utilize real-life evidence (RWE). These include the identification of devices, accelerating the learning process once the product is available in the market, and making regulatory science dynamic ¹⁰. Regulatory commissions are also considering the possibilities of UDI in enlightening accelerated review schemes and expedited routes in the medical devices and its applicability to changing regulatory paradigms in the USA and in the EU ¹¹.

Though there has been improvement, UDI implementation still has a lot of challenges. In the case of software-based devices, the process of adapting the UDI frameworks to the models of digital distribution and lifecycle management is even more complicated, and it needs to be provided with more clear instructions and unified enforcement ¹². Manufacturers have cited significant strain in operation under the EU MDR, and much of this strain has been brought about by increased clinical-evaluation and documentation requirements, and authors observed that the administrative burden and strain this places on resources could act as a hindrance in systems transitioning to, and being ready to comply with regulations such as EUDAMED ¹³. In addition, the need to revise the schedules, enhance the functionality of the system, and provide economic actors with more expectations is supplemented by the evolving Q&A documents published by the European Commission ¹⁴.

It has been demonstrated that the role of UDI in improving traceability in both the distribution and use of medical devices has contributed to the ability of health systems to better track individual devices through supply chains and correctly attach device identifiers with clinical and inventory data to respond to supply-chain issues more quickly ³. The practical implementation analysis, such as consulting guidance, points to the barriers in the aspects of data governance, the IT infrastructure preparedness, and the lack of uniform preparedness of the manufacturers in Europe ¹⁵. The additional academic literature highlights the fact that MDR/IVDR change that involves complete UDI operationalization is transforming the compliance expectations, vigilance reporting, and device lifecycle test ¹⁶.

UDI implementation is an indication that there are larger regulatory questions such as the inconsistent use of nomenclature, poor interoperability and varying expectation among jurisdictions, which require concerted measures to maintain global trading and provide coordinated vigilance ¹⁷. Health systems’ case reports also demonstrate that there is a lack of UDI capture at the point of care, barcode scanning, and inconsistencies in integration, which directly impact the quality of real-world evidence and post-market surveillance. To these results, industry partner technical guidance documents present useful measures on enhancing the operationalization of UDI, the quality of the data, and compliance preparedness in a multifaceted portfolio of devices ⁵.

Altogether, the facts along with evidence indicate that, though UDI systems in the USA and the EU have contributed significantly to the possibility of global traceability and faster regulatory decision-making, further harmonization, technological investment, and alignment of all stakeholders are needed to achieve the maximum of the advantages of device identification systems.

Method

Through this review, a novel mixed-source narrative review methodology was employed, which incorporates the primary aspects of scoping review methodology suggested by Arksey and O'Malley and developed by Levac et al. to help to map the extensive area of regulatory and empirical evidence ¹⁸,¹⁹. To improve the transparency, some elements of PRISMA 2020 (e.g., structured search reporting and screening steps recording) were selected to be administered, but that did not confine the approach to systematic review format ²⁰. This non-collaborative, hybrid solution has never been applied to UDI implementation before and is thus a new methodological addition to the regulatory, technical, and health-services research spheres.

Focus of Analysis

The literature review considered articles that covered:

The UDI systems in EU and USA have been designed in a regulatory manner.

Digital infrastructure (e.g. labelling, data submission, database architecture).

Traceability, patient safety, and surveillance impacts, including integration with registries and RWE systems.

Role of UDI in expedited approval pathways, real-world evidence generation, and regulatory decision-making.

Findings were synthesized across four themes: regulatory design, implementation, traceability impact, and RWE/expedited approvals allowing structured comparison between EU MDR/IVDR and U.S. FDA frameworks.

Data Sources and Scope

Evidence was sourced from PubMed/MEDLINE, Web of Science, Scopus and Google Scholar, supported by key regulatory documents including the FDA UDI Final Rule and GUDID guidance ¹,²¹, EU MDR/IVDR UDI requirements and MDCG guidance ²²,²³, and IMDRF UDI framework documents ²⁴. HTA and system-level implementation reports, such as the SHTG assessment and NESTcc UDI Playbook, were also included ²⁵,²⁶. Searches covered 2013–2025 and used terms related to UDI, traceability, post market surveillance, real-world evidence, MDR, GUDID and EUDAMED, with additional targeted queries for health-system implementation, device categories and expedited approvals. Eligible sources comprised peer-reviewed literature and official regulatory/HTA documents in English, while technical barcode studies, non-medical identification systems and non-substantive commentaries were excluded. Screening of titles, abstracts and full texts was followed by structured extraction of jurisdiction, device type, implementation focus, and regulatory relevance, with evidence triangulated across regulatory and empirical sources rather than formally appraised for bias.

Results

Regulatory Design and Scope

USA (FDA UDI & GUDID)

Mandatory UDI labelling and GUDID submission for most device classes, with phased compliance dates; some enforcement discretion for certain class I devices ¹. UDI is required for key regulatory and surveillance functions, including recalls, adverse event reporting, and some post-market studies.

EU (MDR/IVDR UDI & EUDAMED)

UDI requirements apply to all but custom-made and investigational devices, with deadlines staggered by risk class (implantable/Class III first; class I last) ². EUDAMED UDI/device module is functional but becomes mandatory for manufacturers only from 28 May 2026, reflecting a slower operational roll-out compared with the US GUDID ²⁷. These two systems are based on common issuing entities (GS1, HIBCC, ICCBBA, IFA), that enables interoperability of trade and data globally ².

Table 1. Comparative Overview of UDI Regulatory Frameworks: EU vs USA ¹,²,²⁷

Feature	EU (MDR/IVDR)	USA (FDA UDI Rule)
Central Database	EUDAMED	GUDID
Implementation Status	Staged rollout; mandatory from May 2026	Fully operational since 2013
Scope	All devices except custom-made and investigational	Most device classes; some Class I exemptions
Risk-based Timeline	Class III/implantable first, Class I last	Class III first (2013-2014), Class I last (2018)
UDI Issuing Entities	GS1, HIBCC, ICCBBA, IFA	GS1, HIBCC, ICCBBA, IFA
Integration with Regulatory Processes	Embedded in certificates, declarations of conformity, clinical documentation via Basic UDI-DI	Required for recalls, adverse event reporting, select post-market studies

Implementation in Health Systems and Supply Chains

Empirical research and HTA reports point out:

Inconsistent UDI capture at the point of care: Regulatory progress has not been completely realized into most US health systems through the implementation of UDI scanning into EHRs, peri-operative systems, and inventory ⁵. The experience of EU is less advanced or similar and includes national pilots and professional society initiatives and little published implementation data ²⁵.

Barriers: Outdated IT infrastructure, absence of standardized tasks, absence of clarity over accountability between the supply chain and clinical teams and perceived costs exceeding short-term benefits ⁵.

Facilitators: Have strong executive support, are in agreement with all the grand digital health and quality initiatives, and are perfectly clear about the way UDI enhances safety and regulatory reporting ⁵.

Traceability, Recalls, and Safety Outcomes

Regulatory and HTA documents (e.g., SHTG assessment) stress that a well-functioning UDI system should improve patient identification in recalls, reduce staff time needed to locate affected devices, and strengthen surveillance ²⁵. However, multiple reviews report that quantitative evidence of improved clinical outcomes due specifically to UDI remains limited, largely because UDI capture is still incomplete and time series are short ²⁵.

UDI, Real-World Evidence, and Expedited Approvals

US policy documents and viewpoints argue that UDI is essential to realize the "public health promise" of device RWE, enabling device-specific analyses in EHR, registry and claims data ²⁸. Dhruva et al. and Wilson et al. describe how health systems participating in NESTcc view UDI as a prerequisite for generating RWE that could support premarket decisions (e.g., PMA supplements), post-approval commitments, and surveillance of high-risk cardiovascular devices ³. EU MDR explicitly tightens pre-market clinical evidence requirements and calls for robust post-market clinical follow-up and surveillance; UDI-tagged data in EUDAMED, registries and EHRs are expected to underpin this more dynamic lifecycle approach ². Nevertheless, there are few real-life cases of UDI-driven RWE that are forcing quick approvals or label amendments, and most people are discussing theories or what could occur rather than providing us with completed regulatory narratives ⁵.

Table 2. Identified Gaps Limiting UDI Impact on Traceability and Expedited Approvals ¹³,²⁹,³⁷

Gap category	EU context (MDR/IVDR)	US context (FDA UDI Rule)	Implications for traceability & expedited approvals
Regulatory design gaps	Delayed full EUDAMED functionality and non- mandatory use	GUDID operational but not explicitly embedded in expedited approval frameworks	Fragmented datasets; limited regulatory reliance on UDI-linked RWE
Data interoperability gaps	Limited integration of UDI with national EHRs and registries	Variable EHR vendor support for UDI fields	Incomplete longitudinal device tracking; weak evidence for accelerated decisions
Point-of-care capture gaps	Pilot-based adoption; lack of standardized clinical workflows	Inconsistent barcode scanning and documentation practices	Reduced recall precision and surveillance sensitivity
Manufacturer implementation gaps	Compliance- focused UDI	Uneven alignment between UDI	UDI Underutilized in regulatory submissions
Regulatory use gaps	Conceptual support for UDI – enabled RWE, few documented cases	Similar lack of published regulatory case studies	Limited demonstration of UDI value in expedited approvals

Discussion

Centrality of UDI in contemporary device regulation: UDI is no longer viewed as a technical labelling mandate, but as an element of structure in both European and American lifecycle regulation, but the scholarly and regulatory discourse of both regulatory law, informatics, and hospital operations and HTA is scattered.

Regulatory convergence with divergent implementation: Although the EU and US models are conceptually aligned, the schedule, database maturity, and downstream adoption are vastly different, and this may have consequences in both manufacturer-based on both markets and global ventures in RWE ².

Ambitious expectations vs. limited outcome data: Policy documents are a guarantee of improved safety, faster recalls, and assistance in rapid or responsive approvals, yet we still do not have concrete evidence that these benefits actually occur at a large scale ²⁵.

Digital health and software device implications: SaMD is now moving extremely rapidly, and it is a nightmare to lock down stable IDs, monitor versions, and trace the entire life cycle, so UDI rules are even more significant in this area than ever ¹².

Key Comparative Insights

Regulatory maturity:

USA - we have implemented it previously, GUDID is fairly solid, and we have been fairly useful with UDI when we need to recall something or when we need to keep surveillance systems .

EU: Later timelines, EUDAMED still in staged deployment, but MDR/IVDR embed UDI more tightly into certificates, declarations of conformity, and clinical documentation (via Basic UDI-DI) ².

Downstream use for RWE and expedited approvals: Both regions see UDI as key for robust, device-specific RWE. However, in practice, the main bottleneck is not regulation but data capture and linkage at the health-system level. Without routine scanning of UDI into EHRs, registries and claims, regulators cannot reliably use RWD to support breakthrough or conditional approvals for devices, nor to manage high-risk classes under MDR ³.

Research Gaps

From this synthesis, several priority gaps emerge:

Outcome-level evidence of impact: Few studies directly quantify whether UDI implementation reduces time to complete recalls, decreases patient harm, or improves long-term outcomes for recipients of high-risk devices. Robust quasi-experimental or interrupted time-series studies are needed comparing pre- and post-UDI eras in both jurisdictions ³⁸,³⁹.

Explicit regulatory case studies: There is limited published documentation of regulatory decisions (e.g., label modifications, indication expansions, expedited approvals) explicitly supported by UDI-enabled RWE. Detailed case studies from FDA, notified bodies and HTA agencies could clarify how UDI data are, or could be, operationalized in practice ⁵,⁴⁰.

EU-specific implementation evidence: Compared with the US, there are fewer peer-reviewed evaluations of UDI deployment in EU hospitals and national registries, particularly in the context of MDR transition and EUDAMED mandatory use in 2026 ².

SaMD and rapidly iterating devices: Methodological frameworks for assigning, updating and using UDI for AI-enabled and software-based devices are still emerging. Bianchini et al. note the difficulties but fail to determine how regulators and health systems are to make sense of all those frequent version changes ¹².

Economic evaluations and equity impacts: In addition to the exemplary costing analysis of SHTG, there are not many articles that systematically assess the cost-efficiency of UDI infrastructure, especially in the scaled-up form across EU Member States or different health systems of the US25. Whether or not small hospitals or manufacturers are disadvantaged by the costs of UDI implementation is an area that is mostly untouched in terms of its potential equity implications.

Global harmonization and third-country alignment: Due to the examples of the European Union and the United States, which have developed widely adopted models, there is an urgent necessity of the empirical research of the way the harmonization of unique device identifiers affects not only access to medical devices but also the dependence on regulatory information in low- and middle-income countries ¹⁷.

Conclusion

The comparative analysis shows that UDI implementation in the EU and USA has provided a solid regulatory backbone of better traceability of devices and data-driven regulation, but its ultimate potential is limited by technical, organizational, and data-governance loopholes. In order to transform UDI into a compliance mandate and into a real acceleration and lifecycle-based approvals enabler, the two jurisdictions should focus on the full rollout of databases, regular UDI capture of clinical and administrative systems, the alignment of data standards, and organised utilisation of UDI-linked real-world evidence in regulatory judgements.

Declarations

Funding statement

The study received no external funding.

Author contributions

Conceptualization, D.B. and S.K.M. Methodology, D.B. Formal analysis, D.B. Investigation, D.B. Data Curation, D.B. Writing-Original draft preparation, D.B. Writing-Review and editing, S.K.M. Visualization, D.B. Supervision, S.K.M. Project administration, S.K.M.

Conflict of interest

The authors declare no competing interest.

Data availability

The data supporting the findings of the study are derived from publicly available regulatory guidelines and peer reviewed literature. No new Primary datasets were generated.

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