Navigating the EU MDR UDI Requirements: The Benefits and Challenges

The benefits of Unique Device Identification (UDI) are well recognized globally, with key markets such as the U.S. having already implemented its regulation. As the 10-year anniversary of the U.S. Food and Drug Administration’s 2013 Final UDI Rule approaches, there are more than 3.8 million device identifier records captured in the agency’s public Global Unique Device Identification Database (GUDID).¹ UDI regulation is also underway in the EU and in the planning stages in the U.K., where the government recently announced its intentions to introduce UDI requirements.²

Europe’s new medical device regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) introduced UDI requirements in the EU. Most devices are currently certified under the previous directives, which do not include UDI requirements. Extending the MDR’s transition period to December 2027 for high-risk devices and December 2028 for medium and lower risk devices³ may lead some manufacturers to postpone UDI implementation but given the many benefits of UDI, there are many reasons companies should stay the course.

The Requirements

MDR Chapter 27 sets out key characteristics of the UDI system and details the requirements that manufacturers, and sometimes, distributors and health institutions, must follow to market devices in the EU. Main requirements summaries follow:

Assignment: Manufacturers must assign a UDI and Basic UDI-DI to their devices. This requirement has been in place since the MDR’s May 26, 2021, Date of Application (DoA). The Basic UDI-DI is a concept created by the EU that connects “devices with the same intended purpose, risk class and essential design and manufacturing characteristics.”⁴ The Basic UDI-DI is the primary identifier for EU regulatory purposes and, unlike the UDI, which is used for device traceability, is not required on device labelling. For many devices, a Basic UDI-DI must be assigned before a conformity assessment application.⁵

Labeling: Manufacturers are required to place UDI carriers on device labels and, if applicable, all higher levels of packaging. The UDI carrier includes the UDI in both human readable interpretation and a machine-readable form, the latter of which allows for Automated Identification for Data Capture (AIDC). Examples of AIDC include linear barcodes, data matrix (2D barcodes) and radio frequency identification (RFID). This requirement has been in place since the DoA for MDR-certified implantable and class III medical devices; by May 26, 2023, class IIa and IIb devices must also have UDI carriers on labeling.

Direct marking: The MDR includes requirements for reusable devices to be directly marked with the UDI carrier. In circumstances where the reusable device requires cleaning, disinfection, sterilization or refurbishing between patient uses, the UDI carrier must be permanent and readable after each process. There are exemptions—when direct marking is not technologically feasible, or would impact device safety and/or performance.

Submission: Manufacturers must submit UDI data such as UDI-DI, Basic UDI-DI and device risk class to the Eudamed UDI module. This submission obligation will apply 24 months after Eudamed becomes fully functional, currently estimated as Q2 2026.⁶ However, manufacturers have been able to submit UDI data to Eudamed voluntarily since October 2021.

Storage: The MDR includes requirements for recording UDIs. Manufacturers must keep up-to-date lists in their technical documentation of all UDIs assigned. The UDI retention requirements are not limited to manufacturers; distributors, suppliers and healthcare institutions all are mandated to store UDIs for all class III implantable devices that have been supplied, preferably by electronic means.

Technical documentation: The MDR details documentation in which the UDI and Basic UDI-DI must be recorded. The Basic UDI-DI is required in the conformity declaration⁷ on technical documentation assessment certificates,⁸ and the Summary of Safety and Clinical Performance.⁹ UDI inclusion is mandated in documentation including manufacturer Field Safety Notices¹⁰ and patient implant cards.¹¹

The EU UDI system uses well-established device identification coding systems, such as GS1 Global Trade and Identification Numbers and HIBCC device identifiers, which have been widely used for supply chain control for many years and are already adopted in the U.S. UDI system. The European Commission has designated four issuing entities in total—GS1, HIBCC, IFA GmbH and ICCBBA, which specialize in medical devices using human tissues.

UDI Benefits

The introduction of EU UDI requirements brings considerable benefits in device identification, traceability and patient safety. UDI assignment and labelling allows unambiguous device identification, unlike traditional identifiers (catalogue or reference numbers), which are not unique to specific manufacturers or devices.

UDI also enables manufacturers to better understand the safety and performance of devices in the market. When included in real-world data sources such as registries and electronic patient health records, useful safety and effectiveness data can be generated.

In addition, UDI enables device identification improvements that strengthen patient safety via vigilance reporting and market surveillance by regulators. UDI makes it easier for Competent Authorities to perform market surveillance in a more standardized way, reinforcing patient safety. Furthermore, the standardized UDI registration process simplifies manufacturers’ workloads, ensures information consistency between EU countries, and decreases administrative costs of medical device registration, compared to current highly individualized national systems.

Recall management: UDI indubitably leads to more effective and efficient device recalls. To ensure the benefits are fully realized, UDIs must be captured and recorded electronically throughout their distribution and use. Device UDIs should be integrated into hospital inventory management systems and patient electronic healthcare records. The MDR storage requirements encourage compliance in this area, but this benefit cannot be realized without an effort by all stakeholders.

MDR Article 89 contains a requirement that manufacturers include UDIs in FSNs to accurately identify devices involved in Field Safety Corrective Actions. While it’s important to include UDIs in FSNs, it is vital the UDIs of affected devices are recorded in an accessible digital format. Too often, hospitals are provided with scanned FSNs in PDF format, from which device information is difficult to extract, making it challenging to quickly identify affected devices that require recall. In a device recall, rapid identification is imperative. The GS1 U.K. Healthcare User Group issued guidance in 2017 (updated in 2019) to address this issue, recommending that manufacturers issuing FSNs include an accompanying digital spreadsheet with the UDIs of all affected devices to more quickly detect affected products and patients.¹²

In the U.K., electronically capturing UDIs in the healthcare system has been successfully demonstrated in the Scan4Safety program. The July 2020 Scan4Safety report details how the average time taken to recall a product at Leeds Teaching Hospitals NHS Trust fell from 8.33 days to less than 35 minutes after implementing Scan4Safety. The organization reported £84,411 of staff efficiency savings on recalls from January 2016 to December 2017 alone.¹³

Empowering the healthcare community with information: The Eudamed UDI module creates greater transparency and empowers the healthcare community with key device identification and safety data. Eudamed provides patients with information to which they did not previously have easy access. There are similar benefits for healthcare professionals. Clinicians will be able to review Eudamed prior to using a device and access specific product information such as associated contraindications/critical warnings and whether the device has been subject to an FSCA.
Supply chain efficiencies: UDI strengthens inventory management and procurement processes throughout the supply chain. It enables more accurate, efficient ordering processes, driving automation.

The Challenges

UDI aims to improve patient safety and healthcare efficiencies, however, challenges lie in the lack of understanding UDI requirements, interoperability of hospital systems, and scanning readiness.

UDI harmonization remains a significant concern. A primary objective of the 2013 International Medical Device Regulators Forum (IMDRF) UDI guidance was to help regulatory authorities achieve a globally harmonized approach to UDI.¹⁴ International regulators have sought to harmonize, but variations between jurisdictions can make compliance difficult by requiring additional resources to effectively monitor and manage.

The 2019 IMDRF UDI guidance¹⁵ highlights the “significant challenge with the assignment of multiple UDI-DIs to devices, which share essential design and manufacturing characteristics.” Inconsistent application by manufacturers of UDI-DI triggers15 and variations in UDI-DI triggers set by regulators can lead to uncontrolled UDI proliferation, diminishing the pivotal traceability/visibility benefits that UDI offers.

UDI implementation for high-volume devices with various permutations (i.e., contact lenses) is also an emerging issue. The UDI Working group of the Medical Device Coordination Group has recognized the potential issues with contact lenses and a specific UDI assignment solution is currently under development.¹⁶

Summary

The success of UDI implementation in the EU not only depends on manufacturers assigning and labeling their devices with UDIs, but also on stakeholders capturing and recording UDI in their systems. Additionally, it is imperative that manufacturers understand how UDIs will be used in healthcare delivery. Manufacturers that implement UDI will reap the full array of patient safety and efficiency benefits associated with its implementation. Therefore, this is not an action that should be postponed until regulatory compliance is mandatory, but rather should be prioritized and encouraged by all stakeholders. 

References
1. GUDID Full release (FDA, Jan. 2023)
2. bit.ly/3mgPND0
3. Regulation (EU) 2023/607
4. bit.ly/3Ye38JE
5.-10. Regulation (EU) 2017/745
11. EUDAMED Time line (EC, June 2022)
12. bit.ly/3EKYiwS
13. bit.ly/3mxvzFz
14. bit.ly/3IZE3xS
15. bit.ly/3KGFcvv
16. bit.ly/3IFiRvD

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At MCRA, Bayode Adisa specializes in the development of technical and regulatory documents such as clinical evaluation and post-market surveillance reports. She also helps clients meet global Unique Device Identification (UDI) regulatory requirements. Bayode has over 13 years of experience working with the U.K. regulator of medical devices, MHRA. She is a subject matter expert in UDI and post-market surveillance and possesses a robust understanding of medical device registries.