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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
The FDA has defined four steps to implementing a UDI system:
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 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.
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 barcodes1D 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:
2D barcodes2D 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.
RFID tagAn 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.
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.
CastingThe marking of a device by casting occurs during the manufacturing process, creating a mark intrinsic to the device.
Direct ThermalA 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.
Dot PeenDot 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.
ForgingThe marking of a device by forging occurs during the manufacturing process, creating a mark intrinsic to the device.
Inkjet DirectHigh 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 AnnealLaser 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.
Laser EtchIn laser etching, the laser penetrates the surface of the device, removing material to leave a mark.
Photo EtchPhoto 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.
TextileSome medical devices are made of textile material, such as some orthopedic braces or telemetry monitor halters. These will need a different marking strategy.
Thermal TransferThermal transfer is a cost-effective way to print highly durable UDI 1D or 2D barcodes.
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.
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.
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(Please note that Print Only editions have been discontinued as of BarTender 2016.)
"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