Unique Device Identification (UDI)
GS1 is a globally accredited organization authorized to issue UDI codes in compliance with regulations across multiple regions, including the EU, the USA, and China.
Unique Device Identification (UDI)
GS1 is an accredited issuing agency for UDI identifiers under numerous UDI regulations worldwide, including those of the European Union, Brazil, China, Egypt, Saudi Arabia, Singapore, South Korea, Taiwan, Turkey, and the United States. This means that manufacturers or labelers can use GS1 standards to comply with UDI requirements in these countries.
Important Disclaimer!
GS1, its member organizations, and their staff do not represent regulatory authorities and provide only advisory services focused exclusively on GS1 standards.
What UDI is?
According to International Medical Device Regulators Forum (IMDRF), A UDI (Unique Device Identification) system is intended to provide a single, globally harmonized framework for the unique identification of medical devices during distribution and use. The UDI requires that the product label—or the product itself—bear a globally unique device identifier that can be both human-readable and automatically captured using standardized formats. This identifier and its data carrier must be based on standards from accredited issuing agencies, such as GS1.
Healthcare professionals and patients will no longer need to rely on multiple, inconsistent, and incomplete sources to identify a medical device and its key characteristics. The Unique Device Identification Database (UDID) serves as the designated source for additional information.
The benefits of UDI can only be realized if all stakeholders—from manufacturers to healthcare providers and patients—use the UDI across all their processes and systems. Therefore, it is essential that all stakeholders are educated about the development and use of a UDI system.
Source: IMDRF Unique Device Identification system (UDI)
Across the globe, regulatory authorities, government agencies, and healthcare providers are working toward a globally harmonized implementation of UDI, placing patient safety as a top strategic priority.
UDI and GS1
GS1 is an accredited issuing agency for UDI (Unique Device Identification) codes under numerous regulatory frameworks worldwide, including those of the European Union, Brazil, China, Egypt, Saudi Arabia, Singapore, South Korea, Taiwan, Turkey, and the United States. This means that manufacturers and product labelers can rely on GS1 standards to meet UDI compliance requirements across these regions.
GS1 standards provide a globally recognized framework for the identification, capture, and sharing of medical device information. This supports the consistent, harmonized implementation of UDI regulations around the world. Regulatory UDI requirements are aligned with GS1 standards, as demonstrated in the relevant comparison tables.
GS1’s national member organizations issue GS1 Company Prefixes (GCPs), which are used to generate GS1 identifiers. They also offer localized support and training, helping manufacturers effectively implement UDI requirements at a global scale.
| UDI regulatory requirements | GS1 Standards |
|---|---|
|
Basic UDI-DI
|
GMN (Global Model Number)
|
| Master UDI-DI * |
For devices currently utilising GTIN per existing (made-to-stock) GTIN AI (01) allocation rules: Highly Individualised Device Registration Identifier (HIDRI) AI (8014) SHALL be used as the MUDI-DI (UDI-DI). Made-to-order GTIN AI (03) SHALL be used as the MUDI-DI (UDI-DI) |
| Note |
Master UDI-DI (MUDI-DI) meets a requirement for highly individualised medical devices. The first published regulatory requirement covers contact lens, per both made-to-stock (standard contact lenses per regulation (EU) 2017/745 as amended 7 October 2023) and made-to-order contact lenses. |
| UDI-DI * Device Identifier (DI) |
GTIN * Global Trade Item Number |
| UDI-PI * Production Identifier (PI) (κατά περίπτωση) |
AI * Application Identifier (AI)
|
|
Product Identifier data will vary by medical device type and manufacturer current practice. |
|
| UDI-DI + UDI-PI = UDI | GTIN or GTIN + AI(s) = UDI |
|
* The HRI (Human Readable Information) format shall follow the rules of the UDI Issuing Entity. |
|
The EU Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR) were adopted on 5 April 2017 and define the requirements for the EU UDI system.
On 7 June 2019, GS1 was designated by the European Commission as an issuing entity for Unique Device Identifiers (UDIs). GS1 standards are enabling healthcare manufacturers from around the world to create and maintain UDI numbers by following the EU Regulations and the GS1 General Specifications.
Required product data will be submitted to EUDAMED, i.e. the EU regulatory database for regulated medical devices.
The EU Regulations have introduced a new concept: the Basic UDI-DI, that aims at grouping regulated medical devices under the same identifier. GS1 has developed a new key to support the implementation of the Basic UDI-DI: the Global Model Number (GMN). The GMN generator tool helps generate the GMN (Basic UDI-DI), calculate the related check character pair or verify your GMN (Basic UDI-DI).
The European Commission submitted a work request to GS1 to develop a Master UDI-DI for implementation of a new level of identification for specific products. For more information, and to join the Global Standards Management Process Mission Specific Work Group (GSMP MSWG) see the Call to Action.
Compliance dates for UDI requirements and complementary information by type of actor in the EU are available in the European Commission’s website in the section “Getting ready for the new regulations”.
The European Commission is working on implementation details and is regularly publishing complementary guidances and MDCG endorsed documents, including Q&As and proving guidance on specific device types and assignment rules.
In 2013, the U.S. Food and Drug Administration (U.S. FDA) released the UDI rule. The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use.
According to the U.S. FDA, when fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form, which will ultimately improve patient safety, modernise device postmarket surveillance, and facilitate medical device innovation.
In general, the UDI final rule requires device labelers (typically, the manufacturer) to:
- Include a unique device identifier (UDI), issued under an FDA-accredited issuing agency's UDI system, on device labels, device packages, and in some instances, directly on the device.
- Submit device information to the Global Unique Device Identification Database (GUDID).
Since 17 December 2013, GS1 has been accredited by the U.S. FDA as an issuing agency for Unique Device Identification (UDI).
Usefull Information:
US FDA UDI system dedicated webpage
The Rules for Unique Identification System for Medical Devices (hereinafter referred to as the Rules), released in August 2019 by China National Medical Products Administration (NMPA), has ushered in the stepwise implementation of Unique Identification system for medical devices.
GS1 China is a qualified issuing agency for UDI in China and GS1 standards meet the NMPA’s criteria for issuing UDIs. GS1 Member Organisations across the world will help manufacturers implement with the requirements of the NMPA UDI regulation, to support patient safety and supply chain security.
On October 14, 2019, NMPA issued the Announcement on Effective Implementation of Unique Identification for the First Batch of Medical Devices (hereinafter referred to as the Announcement), which clearly defines the scope, schedule and work requirements of unique identification for the first batch of medical devices. As per the Announcement, for medical devices listed in the first batch, the registrant shall follow the Rules, timely, orderly and effectively perform the coding of Unique Identification, and complete the submission of the registration system and database for unique identification.
On September 29, 2020, NMPA, National Health Commission and National Healthcare Security Administration issued the Announcement on Further Promoting the Pilot and Effective Implementation of Unique Identification for the First Batch of Medical Devices which extended the scope and redefined the schedule.
On September 13, 2021, NMPA, NHC and NHSA issued the Announcement on Effective Implementation of Unique Identification for the Second Batch of Medical Devices.
On February 10, 2022, NMPA, NHC and NHSA issued the Announcement on Effective Implementation of Unique Identification for the Third Batch of Medical Devices.
Usefull Information:
NMPA also published 4 related standards which can be found here.
Quick Guide For NMPA UDID GDSN Testing
China Filing Procedures of GS1 Company Prefix (GCP) / GlobalTrade Item Numbers (GTINs)
Global Model Number (GMN) Generator
The GS1 GMN is used to identify a product model or product family based on characteristics common to the model or family, as defined by industry or regulatory requirements. For medical devices, the GMN is the GS1 identification key that supports the implementation of the Basic UDI-DI.
