UDI Requirements You Should Know

What is the UDI?

The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific medical device on the market. The UDI is comprised of the UDI-DI and UDI-PI.

The unique identifier may include information on the lot or serial number and be able to be applied anywhere in the world. The production of a UDI comprises the following:

  • A UDI device identifier (‘UDI-DI’) specific to a device, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
  • A UDI production identifier (‘UDI-PI’) that identifies the unit of device production, variable portion of a UDI that identifies one or more of the following when included on the label of a device:

    • Lot or batch number within which a device was manufactured
    • Serial number of a specific device
    • Expiration date of a specific device
    • Date a specific device was manufactured


For FDA 510K regulation

In 2013, FDA published its final guidance on unique device identifiers for medical device companies, requiring manufacturers of certain devices to establish a UDI Management Tool that would be used to identify devices and support product traceability from the manufacturer to the end user, and throughout global supply chains.

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.

The UDI Rule requires device labelers (typically, the manufacturer) to:

  • Include a unique device identifier (UDI) on device labels and packages, except where the rule provides for an exception or alternative.
  • If a device is intended for more than one use and intended to be reprocessed before each use, the device labeler must also mark the UDI directly on the device.
  • Submit device information to the Global Unique Device Identification Database (GUDID).


For EU regulation

Two new Regulations (Regulation (EU) 745/2017 on medical devices and Regulation (EU) 746/2017 on In Vitro diagnostic medical devices) were adopted in April 2017 and entered into force on 25 May 2017. The general application dates of the two Regulations are 25 May 2020 for medical devices and 25 May 2022 for In Vitro diagnostic medical devices, though different timelines apply for certain specific provisions.

These Regulations introduce an EU identification system for medical devices based on a Unique Device Identifier (UDI).Article 27 of Regulation (EU) 2017/745 (‘MDR’) and Article 24 of Regulation (EU) 2017/746 (‘IVDR’) lay down that the UDI Management Tool shall consist of:

  • the production of a UDI that comprises a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to the information, and a UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Annex VI
  • the placing of the UDI carrier on the label of the device or on its packaging or in case of reusable devices on the device itself (direct marking);
  • the storage of the UDI by economic operators, health institutions and healthcare professionals, in accordance with the conditions laid down in paragraphs 8 and 9, respectively, of the Articles;
  • the establishment of an electronic database for Unique Device Identification (the ‘UDI database’), which is part of the EUDAMED database, in accordance with Article 28 of MDR and Article 25 of IVDR.

In accordance with the new rules, any manufacturer shall thus assign a unique UDI to a device and to all higher levels of packaging before placing that device on the EU market except custom-made medical devices and performance study/investigational devices. The UDI carrier shall be placed on the label of the device and on all higher levels of packaging and in case of reusable devices on the device itself (direct marking).

For ISO13485 certification

Medical device companies must maintain records of each production unit, lot or batch of product created - information that should be documented in the device history record (DHR). With WhaleTeq UDI management tool, medical device companies can enjoy and benefit from an automated system that generates all information needed for compliance with the UDI requirements. Device makers are able to securely maintain all data needed to comply with UDI requirements and ensure complete product traceability in a single source of truth within the robust system.