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

US FDA UDI Regulation

The US 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 US 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 US Food and Drug Administration (FDA) as issuing agency for unique device identifiers (UDIs).

Global GS1 standards meet the US 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 5 April 2017 and define the requirements for the EU UDI system.

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. 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 EU Regulations: the Basic UDI-DI, that allows to group regulated medical devices within EUDAMED.

GS1 has developed a new key to support the implementation of the Basic UDI-DI: the Global Model Number (GMN). The latest version of the GMN is available online.

Download our brochure on UDI in Europe.

To calculate the GMN check characters or to verify your GMN (Basic UDI-DI), you can use the tool that GS1 has developed. Click here to access it.

Required product data must be submitted to EUDAMED, the EU regulatory database for regulated medical devices.

 

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. 

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.

 

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