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Unique Device Identification (UDI)

BarTender® software is a secure component of FDA-compliant UDI installations around the world. The medical device industry chooses BarTender for its ease of deployment and configurable technology, all backed by industry expertise — we understand the regulatory and process pressures medical device manufacturers face.

Explore the interactive content in the tabs below — learn everything you need to know about UDI marking: Label elements, deadlines, Auto ID technologies for UDI, marking methods.


UDI compliant labeling

A UDI is an identifier or code on a medical device, label or package that enables tracking of the device. It includes two parts: A static Device Identifier (DI) specific to a version or model, and a Production Identifier (PI), a dynamic number that is determined by several different data. The label of every medical device and every device package must display a UDI in both machine- and human-readable forms.

Hover over the labels to learn more about the components of a UDI label. Hover here to show RFID

AIDC: 2D Barcodes

Both labels feature a 2D GS1 DataMatrix barcode. The additional axis of the 2D barcode offers the ability to convey more data in a much smaller footprint. The UDI must appear in both AIDC and human readable on the label.

BarTender comes with over 400 preformatted, ready-to-use barcode components, including a wide array of 2D symbologies.

AIDC: 1D Barcodes

The larger label includes a 1D Code 39 barcode, which may be a requirement for some health care systems. End user requirements are an important consideration when selecting an Auto ID technology for UDI.

Whichever technology you choose, BarTender makes AIDC easy, with over 400 preformatted, ready-to-use barcode components, based on 59 different barcode symbologies and 12 additional barcode standards.

Date

Including a date isn’t mandatory. However, if a date does appear on a label, it must also be included in the PI information.

Any date used (use-by date, manufacture date) must be formatted to the ISO standard: YYYY-MM-DD. Dashes are required.

Color

A UDI label can be simple, complex or somewhere in between. Color can be used to support corporate branding, or even to provide another axis of information on certain barcode symbologies.

BarTender offers superior color capabilities for text and graphics, with an easy-to-use, intuitive design interface.

Device Identifier (DI)

The DI can only identify a single model or version, and only one DI from an issuing agency can be used to identify a particular version or model. A GS1 GTIN or HIBCC LIC may serve as a device’s DI.

A DI cannot be reused — a new DI is required when a device is changed, resulting in a new model or version.

Product Identifier (PI)

The PI is a dynamic number, specific to the device version or model, and must include any data that appears on the label, such as the lot / batch number, serial number, manufacturing date or expiration date.

In the case of these labels, the PI is comprised of the lot number and date.

AIDC: RFID

When the UDI must be read without the line of sight required by a barcode, using RFID as a UDI AIDC technology can provide supply chain efficiencies. RFID also offers unique post-market surveillance capabilities for implantable devices.

BarTender fully supports a comprehensive list of RFID tags and encodings, with templates that include built-in RFID antennas and business rules that enable regulatory compliance.

Symbols

Manufacturers can opt for very simple UDI labeling, or may decide to include multiple data points on a label, some represented by icons and symbols. With BarTender, commonly used symbols such as the EU's CE symbol, and icons for data such as use-by date, manufactured date, and "Fragile" are easy to include in a UDI label.


Creating a UDI system

The FDA has defined four steps to implementing a UDI system:

  1. Develop standardized UDIs
    UDIs are created and maintained by the medical device manufacturer through FDA-accredited issuing agencies, including GS1, HIBCC and ICCBBA.

  2. Put the UDI in human readable and AIDC on the device label
    The label is the default location for the UDI, and every medical device must be marked. Every device package must also have a UDI.

  3. Submit required data to the GUDID database
    The FDA’s Global UDI Database (GUDID, pronounced “Good ID”) is the publicly searchable repository for medical device information.

  4. Meet implementation timelines


Global efforts to harmonize UDI

The global nature of the medical device industry presents implementation problems for UDI. How does an industry whose manufacturers and end users are situated around the world, in a multitude of regulatory jurisdictions, enable traceability? Can a collection of diverse device identification systems efficiently protect global patient safety, or does every country in the world need to agree to a common set of protocols?

UDI systems will never be identical across geographies, but for any of the systems to work, there does need to be some manner of regulatory convergence.

The International Medical Device Regulators Forum (IMDRF) was formed to facilitate harmonization of UDI regulations. IMDRF is managed by the US FDA, Health Canada, European Commission Directorate General Health and Consumers, Japan’s Pharmaceutical and Medical Devices Agency, Brazil’s ANVISA, and Australia’s Therapeutic Goods Administration, with the WHO as official observer.

The consortium’s goal is to create a harmonized global UDI database (UDID), whose core elements include:

  • The UDI and UDI Carrier are based on standards
  • A UDI applied to a medical device anywhere in the world should be able to be used globally and to meet the UDI requirements of its regulatory authority
  • National or local identification numbers should not be a substitute for UDI
  • Regulatory authorities should not specify the procedure for modifying these UDI standards
  • The UDID core elements should not be modified
  • The UDID should use the HL7 Structured Product Label (SPL) and web-based interface for data submission
  • Every medical device needs to be identified by a UDI, unless it is exempted

The IMDRF also states that national or regional regulations should not restrict AIDC methods. The group anticipates that its work will provide unique agreed datasets, protocols and validation procedures that use the same architecture, format and a unique IT language.


UDI timelines in the US

  • September 24, 2014 (one year post-Final Rule)
    The labels and packages of Class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI, and be submitted to GUDID. (A one-year extension may be requested.) Class III stand-alone software must also provide its UDI.

  • September 24, 2015 (two years post-Final Rule)
    The labels and packages of implantable, life-supporting and life-sustaining devices must bear a UDI, and be submitted to GUDID. Devices that are intended to be used more than once and reprocessed between uses must bear a permanent UDI directly on the device itself. Stand-alone software that is life supporting or life sustaining must also provide its UDI.

  • September 24, 2016 (three years post-Final Rule)
    Those Class III devices that require a UDI, and that are intended to be used more than once and reprocessed between uses, must bear a permanent UDI directly on the device itself. The labels and packages of Class II medical devices must bear a UDI, and be submitted to GUDID.

  • September 24, 2018 (five years post-Final Rule)
    Those Class II devices that require a UDI, and that are intended to be used more than once and reprocessed between uses, must bear a permanent UDI directly on the device itself. The labels and packages of Class I medical devices must bear a UDI, and be submitted to GUDID.

  • September 24, 2020 (seven years post-Final Rule)
    Those Class I devices that require a UDI, and that are intended to be used more than once and reprocessed between uses, must bear a permanent UDI directly on the device itself.

Marking technologies and UDI

Which AIDC technology should I choose?
The IMDRF stipulates in its core recommendations that UDI regulations “not restrict methods of AIDC,” and so, the US FDA did not specify an AIDC technology in its Final Rule.

Leaving the choice of technology open to the manufacturer enables a more rapid adoption of a global UDI system, and opens medical device manufacturers and regulators to future use of any new technologies that may be on the horizon.

Click on the icons below to learn more about the Auto ID technologies and marking methods that will be used to meet UDI requirements.

1D barcodes

1D barcodes are ubiquitous, simply produced and easily read. Most health care facilities own scanners that read 1D barcode symbologies. Some common 1D medical device barcodes:

  • Code 39 can encode fewer characters than most barcodes in use today. However, the world’s largest purchaser of medical devices is the US Department of Defense, and the DoD specifies Code 39 marking for many applications in its supply chain.
  • Code 128 can encode any of the 128 ASCII characters and is more efficient than Code 39, so that more information can be stored in a relatively compact space. ICCBBA 128 is a specialized Code 128 for labeling blood — the FDA classifies human tissue as a medical device.
  • The DataBar family of barcodes is owned by GS1, one of the issuing agencies for UDI. It includes barcodes common to the health care sector, formatted with a smaller footprint for use on small items.

2D barcodes

2D barcodes use a series of square dots arranged in a grid pattern to encode any manner of alpha-numeric information, and include robust error correction. 2D codes were formerly considered an “exotic” technology, because scanners were rare. Now that mobile devices and 2D code-reading apps are readily available, 2D has become more viable and is poised to become the standard for medical device marking.

Symbologies include Data Matrix, QR Code, Aztec Code and PDF 417. Adding the second axis vastly increases the amount of data that can be held in a code, and color can provide a third axis of information.

RFID tag

An RFID tag needs only to be within a certain distance of a scanner to be read — it does not require direct line of sight, as does a barcode. The tag can be sewn into in a textile device, included in a carton or even embedded in an implantable device.

A device that features a Read-Write RFID tag provides dynamic data exchange between the device and a user. Read-Write RFID also has the potential to connect a medical device to the Internet of Things (IoT).

Marking methods

How can I create a UDI mark?
The marking method will vary, depending on the material to be marked, the device's use environment and its application. Click one of the materials below to see the relevant marking methods, then click a method for more details.

  • Casting, etching, peening plastic devices
    Plastics/Elastomers
  • Casting, etching, peening, forging, annealing metal devices
    Metals
  • Textile devices: embroidery and dye processes
    Fabrics
  • Direct inkject and thermal transfer label printing
    Cartons
  • Direct thermal and thermal transfer label printing
    Labels
  • Casting
  • Direct Thermal
  • Dot Peen
  • Forging
  • Inkjet

  • Laser Anneal
  • Laser Etch
  • Photo Etch
  • Thermal Transfer

  • Textile Marking Methods

Casting

The marking of a device by casting occurs during the manufacturing process, creating a mark intrinsic to the device.

Casting requires heating a metal, plastic or elastomer to liquid state, and then pouring it into a mold to cool and harden into the desired shape.

Direct Thermal

A direct thermal printer doesn’t use ink or toner to print a medical device label. Instead, chemically treated, heat-sensitive paper moves past the print head, which heats the paper to create black marks.

Direct thermal labeling is an extremely cost-effective way to create UDI labels, but the mark is not durable.

Dot Peen

Dot peen marks (also called pin marks) are used to produce 2D Data Matrix codes. They are created by a mechanical pin, which stamps a series of small dots into the surface of the device.

Dot peen can be used on any hard-surface medical device.

Forging

The marking of a device by forging occurs during the manufacturing process, creating a mark intrinsic to the device.

The forging process begins with the raw material in a solid state. Mechanical force, such as a hammer or high-pressure water jet, or thermal force (heat) are applied to form the material into its shape.

Inkjet Direct

High resolution (300+ dpi) inkjet direct marking is primarily used at the end of production line. Because no labels are involved, inkjet can be an economical approach to case marking.

Laser Anneal

Laser annealing is used to mark devices made of ferrous metal by heating the surface of the device to create an oxide layer. The mark is completely smooth, maintaining the surface integrity of the device.

Annealing is used on implantable devices, such as orthopedic joint replacements, and on devices sterilized or otherwise reprocessed, such as scalpels or dental drills.

Laser Etch

In laser etching, the laser penetrates the surface of the device, removing material to leave a mark.

Etching can be used on metals, but can also be applied to a broader selection of substrates, plastics and elastomers, for example.

Photo Etch

Photo etching uses a chemical process to create a mark on a ferrous or non-ferrous metal, and is commonly used to mark aluminum medical devices.

The surface of the device is coated with a chemical photo resist, and then a UV light is projected on the device in the pattern of the mark.

Textile

Some medical devices are made of textile material, such as some orthopedic braces or telemetry monitor halters. These will need a different marking strategy.

Common approaches include embroidery and dye processes. 1D barcodes will not render in high enough resolution for textile use, so another technology must be used. 2D barcodes are common. Look for expanded use of RFID, which can be sewn into a textile device.

Thermal Transfer

Thermal transfer is a cost-effective way to print highly durable UDI 1D or 2D barcodes.

The printer head heats the ink ribbon (the “thermal”). The ribbon melts onto the surface to be printed (the “transfer”), and the ink is absorbed into the label, creating a high-resolution UDI.

BarTender and UDI: Dependable. Scalable. Adaptable.

BarTender® is the marking software that adapts to meet the global regulations and business demands of UDI. The medical device industry, from multinational, enterprise-level companies to manufacturers producing small, specialized product lines, counts on BarTender for the secure, auditable barcode and RFID labeling that helps maintain regulatory compliance and keeps their businesses running.

BarTender offers centralized control and full audit trail capabilities including electronic signatures throughout all labeling processes to help meet the security requirements of UDI systems. Printer-based licensing and layers of customizable settings add broad protections, with features ranging from simple print-only settings to complex role-based permissions and label format encryption.

Regulatory and production landscapes will continue to change, and BarTender’s simple, intuitive templates enable rapid transformation of your designs, formats and processes, with support for meeting evolving interoperability standards through HL7-based UDI database (UDID) communication.

BarTender is your trusted UDI partner


Which BarTender is right for you?

Select an edition below to learn more, or download the free 30-day trial to explore all of BarTender’s features and see how it can solve your toughest needs for labeling, barcoding and more. Or contact us to learn more about why BarTender is the most trusted software of its kind.

Create
(Design and Print)

Basic Edition

Professional Edition

Get started in just minutes!

All Basic features, plus:

  • Design and print labels, cards, mag stripe cards and more.
  • Optimize print speed to any printer or marking device.
  • Design data-entry forms that provide data validation and accept print-time input from the keyboard or a barcode scanner.

Licensed per PC

  • Read data from CSV files, databases and Excel. Easily search and select records for printing.
  • Encode RFID labels.

Licensed per PC

Create & Automate
(Design, Print and Control)

Automation Edition

Enterprise Automation Edition

All Professional features, plus:

All Automation features, plus:

  • Automatically print from any OS, system or device in response to data transactions and SDK requests.
  • Design using Intelligent TemplatesTM to reduce maintenance.
  • Secure the printing environment with user and group roles.
  • Monitor live print status and view detailed history of system usage.

Licensed per printer

  • Print from any iOS or Android device with the BarTender Print Portal App
  • Automatically print in response to Web service API or TCP/IP communication.
  • Integrate with SAP and Oracle.
  • Take advantage of centralized system management, browser-hosted printing, centralized template storage with revision control, electronic signature support, full SDK control, smart card encoding and more.

Licensed per printer

(Please note that Print Only editions have been discontinued as of BarTender 2016.)

More Information

Industry Solution
BarTender Software for Medical Device Labeling and Marking

Regulatory Solution
BarTender and FDA 21 CFR Part 11

PDF Sheet
BarTender Software for Labeling Medical Devices

Case Study
Global, Multi-Facility FDA 21 CFR Part 11 Pharma Labeling

Industry Solution
Supply chain labeling management

BarTender Overview

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Our Customers Say

"We evaluated several competing solutions, and found BarTender to be the best choice because of its advanced programming interface, solid reliability, exceptional support and unmatched flexibility for label design and printing. Integrating BarTender into Innovatum's ROBAR system enables the world's best label software to be used in compliance with all US and international labeling regulations."

— Ardi Batmanghelidj, President, Innovatum, maker of ROBAR label system for FDA regulated pharmaceutical, medical device, and biotechnology environments