Guide to UDI Labeling Requirements and UDI Printers

In medical device manufacturing, Unique Device Identification (UDI) has been an important part for medical safety and traceability. UDIs are unique codes assigned to medical devices, enabling their identification and tracking through their distribution and use. This article aims to discuss UDI labeling requirements, and guide you in selecting the right UDI printer for your needs.

What Does the UDI Stand For?

UDI, short for Unique Device Identification, is a system developed under the guidance of the U.S. Food and Drug Administration (FDA). It’s primarily designed to support the health and safety of patients.

The UDI system requires that medical devices and equipment, such as surgical instruments and diagnostic equipment, should be labeled with a unique UDI code, which facilitates the precise identification of these devices. This system aids in managing recalls effectively, preventing counterfeit products, and facilitating more efficient medical device reporting.

UDI Labeling Requirements

Now, the UDI system has been increasingly adopted globally by many regulatory bodies such as the U.S. FDA and the European Union through the Medical Device Regulation (MDR) in the medical device industry. The standard components of UDI codes generally include:

1. Device Identifier (DI): Identifies the labeler (manufacturer or distributor) and the specific version or model of the device.

2. Production Identifier (PI): Provides information about the individual device, which may include the lot or batch number, serial number, expiration date, and the date of manufacture.

So how does a UDI work? UDI code is typically represented in a barcode or QR code format. And it must be included on the device label and packaging, and in some cases, directly on the device. When scanned with devices such as 2D barcode scanners or other electronic readers, this system allows for the rapid and accurate identification of medical devices, including hearing aids, prosthetics, X-ray machines, CT scanners, glucometers, and syringes.

The scanning process efficiently retrieves data encoded in the UDI, such as the manufacturer’s details, product model, batch or lot number, and expiration date. This identification method is very swift, reducing the likelihood of human error in data retrieval, and also offers more reliable tracking and management of medical devices.

According to UDI labeling requirements, these medical device labels are needed to be in both machine-readable formats, such as barcodes or QR codes, and in human-readable formats. This dual-format approach facilitates accessibility for electronic scanning systems and provides direct readability for healthcare providers and patients.

Choosing the Right UDI Printer

Selecting the right UDI label printer is crucial for compliance. For large medical device manufacturers and suppliers, most of them prefer industrial barcode printers for bulk printing of UDI labels and barcodes. These industrial printers can meet the rigorous standards of medical device labeling, producing clear, durable, and accurate labels.

When choosing a UDI label printer, consider factors like print speed, print resolution, label size, compatibility with various materials, and ease of use.

iDPRT iK4 is your ideal UDI printer for medical device UDI labeling. This high resolution industrial barcode printer offers:

1. Heavy-duty Printing: Engineered with a high-quality print head and a robust metal body, this medical device label printer delivers fast, stable performance for continuous 24/7 UDI label printing, ideal for the demanding requirements of medical label production.

2. High-Resolution Printing for UDI Compliance: Achieve up to 600dpi printing resolution, offering clarity and precision for UDI labels and barcodes, even as small as 3mm.

3. Versatile Material Compatibility: Efficiently handles various label materials including PP, PE, Polyester, and Tamper-Evident, making it an ideal UDI label printer for diverse medical applications.

4. Expansive Connectivity Options: With interfaces like USB, Serial port, and Ethernet port, plus options for WiFi and UHF RFID extensions, the iK4 is a highly adaptable medical device label printer.

5. Multi-Language Programming Support: Compatible with DPL, EPL2, ZPL-II, TSPL, the iK4 can integrate seamlessly with various systems such as ERP, MES, and QMS.

6. Customization and Scalability: Scale up your UDI labeling operations with optional features like a bottom paper rewinding device, label peeler, and cutter module.

iK4 industrial label printer offers high-resolution printing, ease of integration with existing systems, and reliability in producing UDI codes and labels. This medical label printer is suitable for labeling a wide range of medical devices, including implantable devices, surgical instruments and tools, medical monitoring devices, and laboratory equipment.

But there’s more: the iK4-R600 series now comes with an innovative barcode inspection feature. This high-performance industrial barcode printer is a game-changer for medical device manufacturers seeking to enhance the quality of their barcode and UDI label printing.

It can verify and validate UDI barcodes and labels right as they are printed, ensuring each label is perfect. The data on each label is validated through an OCR module, ensuring it matches the data sent from the host system. This barcode inspection system offers online 100% barcode inspection, eliminating duplicate barcodes and missed codes while detecting text and graphic print defects.

With the right UDI printer, medical device manufacturers can ensure compliance and contribute to the overall safety and efficacy of healthcare.

If you’re looking to integrate UDI printers into your production line or need more information on selecting the right model, explore our range of industrial barcode printers. Contact our team for a consultation to find the best solution for your needs.