Unique Device Identification (UDI)

The Unique Device Identification (UDI) is a system used to mark and identify medical devices within the healthcare supply chain. 

The IMDRF (International Medical Device Regulator Forum), the United States Food and Drug Administration (FDA) and the European Commission are aiming for a globally harmonised and consistent approach to increase patient safety and help optimise patient care by proposing a harmonised legislation for Unique Device Identification (UDI), using global standards.

Download our brochure on the fundamentals of UDI

U.S. FDA UDI Regulation

The U.S. FDA released, in September 2013 a rule which establishes that a common, worldwide system for product identification should be applied to all medical devices placed on the U.S. market. The rule establishes that: 

  • unique device identifier number should be assigned by the device manufacturer to each version or model of a device
  • the unique device identifier should be both in human readable format and in AutoID format. By default, this information will be applied on the label of each device uniquely identified.

UDI should be applied to all medical devices made available on the US market. Download here the GHTF document which defines the term "Medical Device".

On 17 December 2013, GS1 has been accredited by the U.S. Food and Drug Administration (FDA) as issuing agency for unique device identifiers (UDIs).

Global GS1 standards meet the U.S. government’s criteria for issuing UDIs and will help manufacturers comply with the requirements of the FDA UDI regulation, to support patient safety and supply chain security.

EU UDI requirements

The EU Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR) have been adopted on 25 April 2017 and define the requirements for the EU UDI system.

GS1 has already started work to ensure that healthcare manufacturers from around the world, can create and maintain UDI numbers by following the EU Regulations and the GS1 General Specifications. According to the Regulations, a UDI number must be applied to the medical device label, its packaging and, in some cases, the device itself. A new concept has been introduced by the Regulations: the Basic UDI-DI. GS1 has developed a new key to support implementation of this new requirement: the Global Model Number (GMN), BUDI-DI for EU regulated medical devices. The standard is planned to be published on our website on 2nd September 2017. Required product data must be submitted to Eudamed, the central European database. GDSN will be mapped with the UDI module of Eudamed.

 

Advantages of GS1 standards for the implementation of UDI

A single, global system of standards is fundamental to enable an efficient and effective implementation of UDI requirements by all healthcare stakeholders worldwide. Read the McKinsey & Company report, "Strength in Unity", which demonstrates the benefits of implementing one single global standard in Healthcare.

GS1 has over 110 Member Organisations worldwide providing support to users on how to implement UDI in their local language and understanding the local situation.