What Is Unique Device Identification (UDI)?

The unique device identification system is a framework for labeling medical devices with a specific identifier, the UDI, which enables accurate tracking and data collection throughout the device’s lifecycle. A UDI consists of two parts:

1. Device Identifier (DI): Identifies the specific version or model of the device.
2. Production Identifier (PI): Contains variable information related to production, such as lot number, expiration date, and serial number.

This identifier, displayed on device labels in human- and machine-readable forms, allows regulatory bodies, manufacturers, and healthcare providers to track medical devices for improved patient safety, easier recalls, and more efficient inventory management.

Why Global UDI Implementation Matters

Given the international reach of many medical device companies, understanding the nuances of UDI requirements across different regions is essential. Non-compliance with UDI regulations in any given market can restrict a manufacturer’s ability to sell products in that area, which can have significant financial and operational repercussions. With each region implementing its UDI regulations in unique ways, manufacturers must adopt a tailored approach to meet compliance in each market.

UDI Implementation in Key Regions

The global adoption of the UDI system is led by major regulatory bodies, each with its own requirements and compliance timelines. Let’s explore the key differences in UDI regulations across regions.

1. United States: FDA UDI Requirements

The Food and Drug Administration (FDA) was the first major regulatory body to mandate the UDI system, introducing requirements in 2013 for medical devices sold in the United States. The FDA’s UDI rule applies to most devices and emphasizes patient safety through accurate device tracking. Key requirements include:

• Labeling Requirements: All UDI labels must contain both human-readable and machine-readable information, typically as a barcode.
• Global Unique Device Identification Database (GUDID): Manufacturers must submit UDI information to the FDA’s GUDID database, which stores critical device information accessible by healthcare providers and the public.
• Class-Based Compliance Timelines: The FDA rolled out UDI requirements in phases based on device risk class, with high-risk (Class III) devices required to comply first, followed by moderate-risk (Class II) and low-risk (Class I) devices.

The FDA’s phased approach emphasizes patient safety and helps manufacturers adapt their production and labeling systems. Non-compliance can result in penalties, market access restrictions, or delays in FDA approval.

2. European Union: MDR and EUDAMED Database

The European Union’s approach to UDI is outlined in the Medical Device Regulation (MDR), which replaced the previous Medical Device Directive (MDD) and introduced strict UDI requirements for devices marketed in the EU. The EU’s UDI framework shares some similarities with the FDA’s but has unique elements:

• Labeling and Data Submission Requirements: Like the FDA, the EU requires UDI labels to be human- and machine-readable. However, the EU mandates that UDI data be submitted to the European Database on Medical Devices (EUDAMED).
• Direct Marking Requirements: For certain reusable devices that must undergo sterilization, the EU requires direct marking of the UDI on the device itself.
• Device Classifications and Timelines: The EU’s MDR categorizes devices by risk, with higher-risk devices required to comply first. Although implementation has been delayed, compliance deadlines for MDR UDI requirements are approaching quickly, especially for Class I and II devices.

The EUDAMED database is central to the EU’s approach, allowing regulatory bodies across the EU to access accurate, updated device data. EUDAMED is not yet fully operational, but manufacturers must prepare for its eventual activation to ensure compliance.

3. Japan: UDI under PMDA Guidance

Japan, known for its rigorous medical device regulations, follows UDI requirements set by the Pharmaceuticals and Medical Devices Agency (PMDA). Japan’s UDI system, while similar in purpose to those in the U.S. and EU, has distinct features:

• Local Language Requirements: All UDI information must be displayed in Japanese, ensuring that healthcare providers can accurately read and interpret the labels.
• Japan Medical Device Nomenclature (JMDN): Japan mandates that devices include a JMDN code, a unique identifier specific to the Japanese regulatory framework, alongside the UDI.
• No Centralized Database Requirement: Unlike the FDA’s GUDID or the EU’s EUDAMED, Japan does not currently require submission of UDI data to a centralized database.

Manufacturers aiming to enter the Japanese market must prepare device labeling in Japanese and adapt to the local nomenclature requirements for successful UDI compliance.

4. China: NMPA UDI Regulations

China’s National Medical Products Administration (NMPA) has established its UDI system to improve device tracking and safety. China’s approach closely mirrors the FDA’s but has unique aspects tailored to the local market:

• China UDI Database: The NMPA requires that device information be submitted to a Chinese UDI database for regulatory oversight and tracking.
• Device Labeling in Chinese: All UDI information must be presented in Chinese, following NMPA guidelines to ensure local healthcare providers can read and verify device information.
• Phased Implementation: Similar to the FDA, China’s UDI requirements are phased in according to device risk class, prioritizing higher-risk devices for early compliance.

For manufacturers, navigating China’s regulatory landscape involves understanding local language requirements and ensuring compliance with the NMPA’s phased UDI timelines.

5. Other Regions: Australia, Brazil, and Canada

Several other countries have also begun implementing UDI frameworks, each with its own requirements:

• Australia: Australia’s Therapeutic Goods Administration (TGA) has been working to align its UDI requirements with international standards, though full implementation is still in progress.
• Brazil: The Brazilian Health Regulatory Agency (ANVISA) has signaled interest in UDI requirements, likely influenced by other major markets, though Brazil’s UDI system remains in development.
• Canada: Health Canada has been considering UDI implementation, looking to align its standards with those of the FDA and EU to facilitate market access and enhance patient safety.

As UDI requirements become standardized across these regions, global manufacturers must stay updated on changing regulations to avoid compliance issues and market entry delays.

Key Differences in Global UDI Requirements

To summarize, here are the primary differences in UDI requirements across regions:

1. Labeling Language and Format
   • U.S. and EU requirements are similar, using human- and machine-readable formats, while Japan and China mandate labels in local languages.
2. Centralized Databases
   • The U.S. (GUDID) and EU (EUDAMED) require UDI data submission to centralized databases. Japan and China have varying database requirements, with Japan not mandating a database submission.
3. Direct Marking Requirements
   • Direct marking on devices is required by the EU for reusable and sterilizable devices, while U.S. requirements may vary depending on device class and reusability.
4. Implementation Timelines by Device Class
   • Phased timelines for high-, moderate-, and low-risk devices vary across regions, requiring manufacturers to tailor compliance plans for each market.

Challenges and Solutions for Global UDI Compliance

For manufacturers, implementing UDI across multiple regions presents several challenges:

• Resource-Intensive Labeling and Translation Needs: Different language and labeling requirements necessitate significant investment in translation and labeling infrastructure.
• Varied Database Submissions: With each region’s unique database requirements, managing UDI data submissions can be complex and time-consuming.
• Ongoing Regulatory Updates: UDI regulations are evolving, and staying updated on new standards is essential for maintaining compliance.

To address these challenges, companies can:

• Invest in centralized data management systems that can be customized for regional requirements.
• Work with regulatory consultants to navigate UDI nuances across different markets.
• Use automated labeling and translation solutions to streamline UDI data preparation and ensure regulatory compliance.

Conclusion

The global implementation of unique device identification varies significantly across regions, with each regulatory body enforcing its own requirements and timelines. For medical device manufacturers, understanding and adhering to these regional UDI regulations is critical to ensure market access, enhance patient safety, and support device traceability. By developing tailored strategies for each market and investing in advanced data management systems, manufacturers can successfully navigate the complexities of global UDI compliance. Staying ahead in this dynamic regulatory landscape not only helps companies maintain compliance but also builds a reputation for quality, safety, and reliability in healthcare markets worldwide.

• Improved Patient Safety.
• Streamlined Regulatory Compliance
• Enhanced Supply Chain Management
• Facilitated Post-market Surveillance

Global Implementation of UDI

The adoption of UDI is becoming increasingly important on a global scale. Various countries are in different stages of implementing UDI regulations, aligning with local requirements and international standards such as those set by the International Medical Device Regulators Forum (IMDRF). Below is a summary of countries that have implemented or are in the process of implementing UDI

An UDI is a distinct numeric or alphanumeric code used to identify medical devices throughout healthcare supply chains. These codes are generated by product owners based on globally accepted standards for device identification.

The UDI code consists of two standard elements, which are:

• Device Identifier (DI): DI identifies the labeler and the model or version of a device. The DI is a required component and considered to be the static portion of the UDI, meaning that it is the same for all instances of the product model or version.
• Production Identifier (PI): PI identifies one or more variable characteristics, such as manufactured date, expiration date, lot number, or serial number. The PI is considered to be the dynamic portion of the UDI, meaning that the PI value changes according to the production controls.

The DI is always first and is followed by the PI if it has a value.

Unique Device Identifier (UDI) = Device Identifier (DI) + Production Identifier (PI)

There are different Issuing Agencies/ Entities for issuing an UDI for a medical device they are:

GS1: Global Standards 1 (GS1) are a nonprofit standards agency, GS1 sets international standards for supply chains, electronic data exchange, healthcare, and more. GTIN (Global Trade Item Number) and UPC (Universal Product Code) are GS1 standards, both are numeric only codes. GS1 provides a “GS1 Company Prefix” to a subscribing organization and reserves a range of “Item Reference” numbers for the organization to assign to their product portfolio. GS1 charges an initial fee and a lower annual renewal fee for the subscription. GS1 is used by the majority of medical device manufacturers.

HIBCC: Health Industry Business Communications Council (HIBCC) is a nonprofit organization focused on setting standards for the healthcare industry. The HIBC (Health Industry Bar Code) standard is managed by HIBCC and is an alphanumeric code. HIBCC provides a Labeler Identification Code (LIC) to an organization after paying a one-time subscription fee. The organization creates and assigns Product/Catalog Numbers (PCN) to their product portfolio without an additional charge.

ICCBBA: International Council for Commonality in Blood Banking Automation (ICCBBA) is a non-governmental organization. ICCBBA focuses exclusively on standards for medical products of human origin, such as blood products, tissues, and organs for transplant. It manages the ISBT 128 standard used in more than 75 countries. Only a few niche medical devices are identified using the ICCBBA standard.

Issuing Agency standards typically define a device identifier to encode a company, a product model, a package level, and a check character used to verify the accuracy of the code. 

UDI codes are included on the product and package labels and, in some cases, printed directly on the device itself. Regulations require the UDI be presented in both Automatic Identification and Data Capture (AIDC) and Human Readable Interpretation (HRI) formats.

The AIDC format is a one- or two-dimensional barcode. This format allows the product to be identified quickly and accurately by using barcode readers and scanner technologies. The HRI text format refers to easily readable text that allows the product to be identified by humans without the use of any scanning or barcode reader technology.

In the case of reused and reprocessed devices, such as a surgical scalpel, the UDI must be directly marked on the product, as the product packaging is discarded. There are different direct marking technologies such as laser etching, to mark the product for the life of the product.

Once the UDI is issued, the data must be securely stored in the manufacturer’s repository and submitted to the respective health authority’s Unique Device Identification Database (UDID).

In general, regulations require product UDI data to be reported to the UDID before the medical device is placed on the market. The UDI Device Identifier and numerous other data attributes need to be collected and submitted to the UDID.

An increasing number of health authorities are implementing UDI requirements to improve patient safety and the patient experience. Accurate, comprehensive product information gleaned from UDIDs is essential to ensure the correct and safe use of devices by all users, including patients, caregivers, healthcare providers, hospitals, and industry.

The primary goal of a UDI system is to ensure proper adverse event reporting among medical devices. UDI increases the accuracy of product traceability and enables medical device manufacturers, regulatory bodies, and other analysts to discover trends earlier and respond quicker in the event patient safety is at risk due to a certain device issue.

In order to effectively streamline UDI labeling and submissions for your medical devices, it is essential to have a thorough understanding of the entire process of development, validation, design, and submission of requirements. DDi offers a single Unique Device Identification (UDI) solution that meets compliance requirements across all countries.

Legacy devices that will be registered in EUDAMED will need two other unique access keys (IDs) to replace the Basic UDI-DI and UDI-DI for the sake of the workability of EUDAMED.

For this purpose, a EUDAMED DI will be assigned to the device instead of the Basic UDI-DI and a EUDAMED ID will be assigned by EUDAMED instead of the UDI-DI allowing the system to work and to keep the design of EUDAMED as close as possible to the MDR design. These EUDAMED DI and EUDAMED ID will be unique for a given legacy device.

Requirements to Register a Legacy device in UDI Module

Once this informationis entered in module, click on “Submit” to submit it directly or “Preview” to view before submitting: A pop-up window will appear asking you to confirm your submission. Once you confirm, you will be brought to a new window confirming the submission of your Legacy device.

Timeline for Submission

Currently, legacy devices should be understood as devices and are placed on the market after the MDR’s date of application -26 May 2021- and until 26 May 2024 if:

• They are class I devices, for which an EC declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body.
• They are devices covered by a valid EC certificate issued prior to 26 May 2021.

The registration of legacy devices in EUDAMED will be only required when the system will be fully functional and only in two particular cases:

• By the end of the transitional period (24 months after publication in the Official Journal of the European Union) if an equivalent device is not made compliant and registered as a MDR device by that date.
• In case of serious incident or field safety corrective action concerning a legacy device, such device must be registered in EUDAMED at the moment of the serious incident/field safety corrective action reporting in the Vigilance module. The Vigilance module will be available when EUDAMED is fully functional.