UDI – Unique Device Identification

Label and identify medical devices

What is UDI?

Unique Device Identification (UDI) is a method of labeling and identifying medical devices to provide a globally unique identification in both distribution and use to increase traceability.

Many countries are adopting laws that require companies that manufacture, label or distribute medical devices to identify them with a UDI. Important information to know is that a Global Trade Item Number (GTIN) issued by GS1 Sweden can be used as a UDI in several countries and territories such as the United States.

Regulations of UDI

The US Food & Drug Administration (FDA) and the European Commission have developed a number of rules and regulations to improve patient safety. The aim is a coordinated and consistent approach at global level, to increase patient safety and optimize patient care through coordinated legislation for UDI and using global standards.

The US UDI Regulation describes how devices classified as medical devices are regulated and can be supplied in the US. It covers several classes of products sold in the United States and includes requirements related to identification, data collection, and trade item information. Legal requirements from the FDA are aimed at suppliers who use GTIN for their medical devices classified under the UDI and sold to the US market.

GS1 is authorized as a UDI issuing agency by the FDA in the US. This means that GS1 is required by law to annually disclose which companies use GTIN to assign UDI to their products where they are sold in the United States. This information is regularly required to the US FDA.

See frequently asked questions about UDI
Read about the new regulations here
Learn more about the manufacturer’s role and key deadlines

Summary

UDI ensures unique identification and traceability of medical devices for increased patient safety and global compliance

  • Improved traceability of medical devices throughout the supply chain.

  • Increased patient safety through accurate and unique identification of products.

  • GTIN can be used as UDIs globally, simplifying international trade.

  • Facilitates compliance with laws and regulations, for example from FDA and MDR.

  • More efficient management of product data and reduced risk of confusion of medical devices.

  • Enables global monitoring and tracking of medical devices.

  • Uniform global standard for the labeling of medical devices.

The manufacturer’s role and important deadlines

Under the new rules, all manufacturers must assign a UDI to a product and its packaging levels before placing it on the market. The UDI carrier must be placed both on the product label and on each packaging level.

Before a device reaches the market, the manufacturer must ensure that all essential information about the device has been correctly submitted and registered in the UDI database according to the rules set out in Part B of Annex VI. In addition, in the EU, the manufacturer must assign a basic UDI-DI to its devices, in addition to the standard UDI.

The basic UDI-DI serves as the primary identifier in the database and for important documentation, such as certificates, declarations of conformity, technical documentation and safety summaries. It will also serve as the access key to product-related information in the future European Medical Devices Database.

Important deadlines

Medical devices according to MDR

Risk class/product categoryUDI carriers on packagingUDI carrier on products to be reused (direct marking)
Class I 26 May 202526 May 2027
Class IIa and IIb 26 May 202326 May 2025
Class III and implants 26 May 202126 May 2023

Medical devices for in vitro‍-‍diagnostics according to IVDR

Risk classUDI carriers on packaging
Class A26 May 2027
Class B and C26 May 2025
Class D26 May 2023

Storage of UDI at the manufacturer

The manufacturer shall maintain, as part of the technical documentation for each device, an updated list of all assigned UDIs. This requirement entered into force on May 26, 2021 for MDR medical devices and on May 26, 2022 for IVDR in vitro diagnostic devices, regardless of the risk class or product category.

Read more about the new regulations here >

Resource Library

UDI and GS1

Requirements for UDI according to IMDRFUDI as applied by the EU in the MDR and IVDR is calledGS1 applies UDI as follows
Unique identificationUDI
Unique Device Identification		GS1 standards
Product Identification
Unique item number Unique identification of products and their packaging for medical devices as well as in-vitro diagnostics products.UDI-DI
Device Identifier (DI), i.e. the identity of a Medical Device.		GTIN
(Global Trade Item Number) uniquely identifies each medical device.
Unique production number, i.e. information associated with one product when it is manufactured and packaged.UDI-PI
Production Identifier (PI), i.e. information from the time of production.
For medical devices intended exclusively for resale outlets (e.g. retail), the UDI-PI does not need to be in the barcode/2D code on the packaging.		Additional information (AI)
By using GS1 standard (AI) – Application Identifiers, production information can be entered into a data carrier such as in
GS1-128 or GS1 DataMatrix:
(17) Issue date
(10) Batch/LOT number
(21) Serial number
(11) Date of manufacture
(8012) Software version
etc.
Automatic reading
of the product’s unique identifier and the production information that should normally be present for a medical device.		AIDC, Automatic Identification and Data Capture.With reading equipment automatically read from data carriers such as GS1-128, GS1 Datamatrix, EPC/RFID containing GTIN and production information. When production information is not on the product, GTIN can be read from barcode EAN 13.
Sharing information about an item
Item data linked to the unique identifier should be stored in a database and shared with those who need access to this data		Unique Device Identification Database, i.e. GUDID database in the USA,
UDID database within EUDAMED for the EU		With GDSN, data can be transferred to the European database EUDAMED. GDSN, (Global Data Syncronisation Network) is a standard for independent item databases developed by users of the GS1 standard to obtain a common standard of describing item data and communicating item data in this global network.
Primary identification of product modelThe basic UDI-DI is the primary identifier for a product model. It is that product identifier (DI) that is assigned at the level of the product’s user unit.GMN, Global Model Number. GMN is used to uniquely identify a product model. Each item in the UDID database is identified by a GTIN. GMN is one of several attributes specified for each item in the UDID database. One GTIN can belong to exactly one GMN. A group of GTIN can all belong to the same GMN. To figure out the check digit for your model number, GMN, go here https://www.gs1.org/services/check-character-calculator
User unitThe product that is used directly in a patient or during the treatment of a patientThe user unit is identified by GTIN.
Manage unique instance of a productFor example, to distinguish two equal products from each otherWith GTIN and Serial Number, a product becomes completely unique and can be used for example to distinguish a surgical instrument so that a specific instrument can return to the same grid after use and that this particular instrument has been used for an identified patient.

Frequently asked questions

As part of the UDI Regulation in the US, GS1 is one of the accredited issuing authority. This requires us to store information about companies that use GS1 standards to assign UDI to their products where they are sold in the United States. This information needs to be reported regularly to the US FDA.

GS1 Sweden shares your company name, your company address and the GS1 company prefix or individual GTIN number assigned to you. The contact name will not be disclosed unless requested by the FDA.

If your product is not sold in the United States as medical equipment, there will be no consequences. If you have a product or products sold in the United States and they are classified as medical devices, please say yes. If we have not shared your information and GTIN with the US FDA, there may be problems with your medical devices available on the US market.

If you do not sell products in the United States, the regulation does not apply to you. However, it is possible that someone else will sell them there after buying them from you. Therefore, you need to confirm whether your product is classified by the FDA as medical equipment.

Yes, you must ensure that this information is maintained regularly so that we can keep the reporting to the US FDA as up to date as possible. If you need to update your response, please contact customer service.

Yes, it is.
According to the MDR there is an exception where EAN-13 can be used for medical devices.
See MDR, Annex VI, Part C, UDI SYSTEM 4.

Yes, GTIN-13 can be used in GS1 DataMatrix or GS1-128.
GTIN-13 contains 13 digits, but in these systems 14 digits are used, which requires the addition of a leading zero. For example. if GTIN-13 is 7300016350759 the leading zero should be added to the the digit string in GS1 DataMatrix i.e. 07300016350759

No, basic UDI-DI is only used in the EUDAMED database and in the Declaration of Conformity.

Yes, according to the MDR, the lot number (LOT) should be included in the UDI-PI, if indicated on the label.

Example of a medical device from a supplier: A manufacturer has delivered a medical device for healthcare to GS1 for review.
The products are labeled with a barcode (EAN-13), as well as REF, LOT, manufacturing date and serial number.
The product is CE marked and the number under the barcode is: 07300016350759. The label contains:

  • EAN-13 barcode: 07300016350759
  • REF: 997766
  • LOT: 110822
  • Production date: 2023-08-11
  • Serial number (SN): 5643

Suggested improvement to meet UDI requirements: Instead of EAN-13 barcode, GS1-128 or GS1 DataMatrix should be used.
GS1 DataMatrix is recommended as GS1-128 may require two lines which may be impractical when scanning in healthcare.

  • REF is not needed for UDI.
  • The barcode or 2D code should contain:
    • GTIN (Global Trade Item Number): 07300016350759
    • Manufacture
    • LOT/BATCH
    • Serial number

If the date of manufacture is present instead of the expiry date, it should be included in the barcode according to the MDR (Medical Device Regulation) rules.
Example: The date of manufacture 2023-08-11 is written as “230811”. Example of human readable information (HRI) for barcode/2D code:

  • (01) 07300016350759 – GTIN
  • (11) 230811 – Date of manufacture
  • (10) 110822 – LOT/BATCH
  • (21) 5643 – Serial number

Explanation of the barcode symbols:

  • (01) = GTIN
  • (11) = Date of manufacture
  • (10) = LOT/BATCH
  • (21) = Serial number

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