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What is UDI?
A Unique Device Identification (UDI) system is intended to provide single, globally harmonized positive identification of medical devices through distribution and use, requiring the label of devices to bear a globally unique device identifier (to be conveyed by using Automatic Identification and Data Capture and, if applicable, its Human Readable Interpretation) based upon standard, with the UDI-DI (Device Identifier) of that unique identifier being also linked to a jurisdiction-specific public UDI database (source: International Medical Device Regulators Forum (IMDRF): http://www.imdrf.org/).
The United States Food and Drug Administration (FDA), the European Commission and other regulators have made patient safety a strategic priority by developing UDI regulations for Medical Devices and In Vitro Diagnostic (IVD) Devices and are aiming for a globally harmonised and consistent approach aligned on the IMDRF Guidelines.
UDI database GDSN mapping
The UDI database GDSN mapping section lists all the healthcare-related documents by country.
UDI and GS1
GS1 is an UDI Issuing Agency/Entity based on many regulations worldwide, in particular US, EU, China, South Korea, Saudi Arabia, meaning that manufacturers supplying regulated medical devices to these markets can use the GS1 standards to implement the UDI requirements.
The GS1 system of standards provides a global framework to identify, capture and share Healthcare product information, thereby enabling a consistent worldwide implementation of UDI. UDI regulatory requirements have a translation into GS1 standards as shown in the table.
GS1 Member Organisations are the ones issuing GS1 Company Prefixes (GCP) enabling the generation of GS1 identification keys. They also provide direct support on the use of GS1 standard to implement UDI requirements worldwide.
| UDI regulatory requirements | GS1 Standards |
|---|---|
| Basic UDI-DI « New » level of identification in the EU |
GMN (Global Model Number) No Application Identifier (AI) for regulated medical devices |
| UDI-DI * Device Identifier (DI) |
GTIN * Global Trade Item Number |
| UDI-PI * Production Identifier (PI) (if applicable) |
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 US Food and Drug Administration (FDA) released in September 2013 a UDI rule which establishes a UDI system applying to all medical devices placed on the US market.
On 17 December 2013, GS1 has been accredited by the US FDA as issuing agency for unique device identifiers (UDIs). GS1 standards meet the US FDA’s criteria for issuing UDIs. GS1 Member Organisations across the world will help manufacturers implement with the requirements of the US FDA UDI regulation, to support patient safety and supply chain security.
Regulated product data must be submitted to the Global Unique Device Identification Database (GUDID), i.e. the US FDA UDI regulatory database.
UDI requirements compliance dates in the US can be found here.
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).
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.
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.
Useful 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)
UDI in the US
The US Food and Drug Administration (FDA) released in September 2013 a UDI rule which establishes a UDI system applying to all medical devices placed on the US market.
On 17 December 2013, GS1 has been accredited by the US FDA as issuing agency for unique device identifiers (UDIs). GS1 standards meet the US FDA’s criteria for issuing UDIs. GS1 Member Organisations across the world will help manufacturers implement with the requirements of the US FDA UDI regulation, to support patient safety and supply chain security.
Regulated product data must be submitted to the Global Unique Device Identification Database (GUDID), i.e. the US FDA UDI regulatory database.
UDI requirements compliance dates in the US can be found here.
UDI in the EU
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).
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.
UDI in China
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.
Useful 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)