Defining UDIs and UDI Requirements

Unique device identification is a method for tracing medical devices throughout their life cycle. While this system is beneficial for improving patient safety and health care processes, understanding the compliance requirements can be complicated. Learn everything you need to know with this guide! 

What Is a UDI?

A unique device identifier (UDI) helps identify and track medical devices throughout the supply chain, from manufacturing to distribution and patient use. The goal of the UDI system is to provide a globally harmonized process for identifying medical devices. Each region has its own regulatory frameworks — the Food and Drug Administration (FDA) establishes UDI standards for the United States, for example — but the core concepts transcend international borders so that devices can be surveilled no matter where they’re manufactured or used.

With the UDI system, each medical device has a unique numeric or alphanumeric code that includes:

• A device identifier (DI): The DI describes the labeler and the device model or version. It remains static, meaning each instance of the product model or version has the same DI. The DI always appears first. 
• A production identifier (PI): The PI identifies variable characteristics, including a device’s serial number or expiration date. 

Codes are included on device labels and packages, and sometimes on the device itself. If a device is intended to be used more than once or reprocessed before each use, there must be a permanent marking on the device itself. Direct part marking (DPM) enables accurate tracking, traceability and compliance after repeated cleaning, sterilization or handling. There are several DPM methods, including laser marking. 

Why Is Including a UDI on Medical Devices Important? 

A medical device UDI is beneficial for: 

• Keeping track of inventory: The system makes it easy to keep track of medical devices, including which are available, which are in use and which need to be restocked. 
• Ensuring patient safety: Medical professionals can ensure patients use the correct devices and prevent product mixups. 
• Combating counterfeiting: The UDI system makes the medical device global supply chain more secure and addresses counterfeiting attempts. 
• Making recalls easier: Manufacturers can quickly identify which devices are affected by a recall and remove them from circulation. 
• Addressing adverse events: Professionals can report device issues to identify patterns and improve the patient experience. 
• Complying with regulations: It is easier to evaluate medical devices for safety and effectiveness with the UDI system. 
• Maintaining traceability: Tracking devices throughout the supply chain is necessary for regulatory compliance and keeps patients safe by making it easier to identify and isolate faulty devices. 

Key UDI Compliance Requirements for Medical Devices

Core UDI requirements are meant to be global. However, each region has specific regulations. 

FDA UDI Requirements in the United States

The FDA published its UDI rule in 2013 and opted for a phased implementation to reduce the burden on the industry. This table describes FDA UDI compliance deadlines for different devices: portant to emphasize that validation should be conducted every three years to ensure accuracy. In certain circumstances, such as machine relocation, additional validation may be necessary to account for potential changes in lighting or other variables.

Device Type	Class I and Unclassified Medical Devices	Class II Medical Devices	Class III Medical Devices	Implantable, Life-Supporting and Life-Sustaining Medical Devices
UDI Label Date	UDIs required for packages and labels since September 24, 2018.	UDIs required for packages and labels since September 24, 2016.	UDIs required for packages and labels since September 24, 2014.	UDIs required for packages and labels since September 24, 2015.
UDI Marking DATE	Direct marking (if necessary) required since September 24, 2020.	Direct marking (if necessary) required since September 24, 2018.	Direct marking (if necessary) required since September 24, 2016.	N/A

The UDI must appear in plain-text and machine-readable forms, usually barcodes or data matrix codes. The human-readable interpretation (HRI) allows individuals to identify the product without any scanning technology, while automatic identification and data capture (AIDC) technology allows the UDI to be entered into a computer system.

Labelers must also use the YYYY-MM-DD format to present dates on labels and packages. This format is consistent with international standards and international practice. 

After including all of the FDA UDI label requirements, labelers submit the information to the Global Unique Device Identification Database (GUDID). The database serves as a reference catalog for every device with a UDI. 

European Union Requirements

European regulations include Medical Devices Regulation (MDR) 2017/745 and the In Vitro Diagnostics Regulation (IVDR) 2017/746. The Unique Device Identification Database (UDID) is the European Database on Medical Devices (EUDAMED). 

Here are the compliance deadlines for medical device UDI compliance in the European Union: 

Device Class	Class I Devices	Class IIa and IIb Devices	Class III And Implantable Devices
UDI Label Date	UDIs required for packages and labels by May 26, 2025.	UDIs required for packages and labels since May 26, 2023.	UDIs required for packages and labels since May 26, 2021
UDI Marking DATE	Direct marking (if necessary) required by May 26, 2027.	Direct marking (if necessary) required by May 26, 2025.	Direct marking (if necessary) required since May 26, 2023.

These are the deadlines for in vitro diagnostic (IVD) devices: 

Device Class	Class A IVD Devices	Class B and C IVD Devices	Class D IVD Devices
UDI Label Date	UDIs required for packages and labels by May 26, 2027.	UDIs required for packages and labels by May 26, 2025.	UDIs required for packages and labels since May 26, 2023

Legacy devices — those already on the market before UDI system implementation — can continue being sold without a UDI until their respective compliance deadline. However, these devices must still comply with registration requirements in EUDAMED during the transition. 

Who Assigns UDIs?

The following organizations are FDA-accredited to assign UDIs: 

• GS1: GS1 is an issuing agency for the U.S., the EU, China, South Korea, Brazil, Egypt and more. They provide standardized formats for barcodes and data matrix codes, making tracking devices and maintaining compliance easier. 
• Health Industry Business Communications Council (HIBCC): Manufacturers can apply for a Labeler Identification Code (LIC). Once assigned an LIC, companies begin creating identifiers. 
• International Council for Commonality in Blood Banking Automation (ICCBBA): This organization focuses on standards for blood products, organs for transplant, tissues and other medical products of human origin. 

While these organizations can help labelers adhere to FDA UDI guidelines, they do not have the authority to speak for regulatory authorities or grant exemptions on behalf of the FDA. 

Common Challenges in UDI Implementation

Labelers may face challenges when implementing the UDI system: 

• Regulatory hurdles: Navigating global regulations and meeting quality standards can pose a challenge for labelers. 
• Maintaining mark quality: It can be difficult to ensure readability after multiple reprocessing cycles. 
• Technical challenges: Limited marking space can make fitting an entire UDI directly on a device challenging. 
• Implementation costs: Implementing the UDI system can be expensive, especially for smaller organizations. 
• Employee resistance: Resistance to the UDI system can lead to inefficiencies and delays. 

How to Achieve UDI Compliance With Laser Marking

Laser marking offers a permanent, precise and reliable direct marking solution for UDI compliance. Laser marking tools use highly concentrated heat to create labels, ensuring markings remain readable even after repeated cleaning and sterilization. 

Laser marking devices enable the creation of high-quality codes and alphanumeric text directly on device surfaces, ensuring compatibility with materials like metals, plastics and ceramics. This system supports the Installation Qualification, Operational Qualification and Performance Qualification (IQ-OQ-PQ) validation process to ensure consistency, accuracy and compliance with FDA and MDI requirements. 

Comply With Guidelines and Maintain Device Integrity With Machinery From Laser Marking Technologies, LLC

Laser Marking Technologies has more than a century of combined experience developing advanced laser technology. Our fiber lasers, CO2 lasers, UV lasers and green lasers are ideal for marking various medical devices with high precision and high speed throughput. 

We’re ready to collaborate on your demanding projects and meet compliance standards. Explore our laser systems or contact us to learn more today!