How to Choose UDI Coding Equipment for Medical Device UDI Implementation

      Recently, we have received many inquiries from customers about how to apply UDI codes on Class II medical devices. Today, we will briefly introduce what enterprises need to do when implementing UDI, how to choose UDI coding equipment, and how to more efficiently complete product UDI coding. Let's take a look:

What is UDI Coding Equipment

UDI refers to specific identification information on medical devices or their packaging, serving as the electronic ID of medical device products.

UDI coding equipment refers to automated printing and coding devices that can print UDI-related information. These devices mainly include inkjet printers, which use printed barcodes or QR codes as UDI data carriers, allowing access to relevant medical device registration and production information.

Product coding is the final step in the UDI implementation process and also a challenge. For enterprises, non-compliant UDI coding may lead to products being unable to circulate, wasting previous UDI implementation efforts. Alternatively, even if coding is compliant, unreasonable production line planning can significantly affect production progress, resulting in wasted funds and time. So what key issues should enterprises focus on during the product coding stage?

1. Choose the Correct UDI Coding Equipment

UDI codes need to be attached to product packaging. Different packaging materials require corresponding coding equipment to ensure clear readability. Currently common UDI coding equipment includes desktop thermal transfer printers, TTO thermal transfer coders, UV inkjet printers, laser coders, TIJ thermal inkjet printers, etc., which basically meet the needs for label printing and coding.

2. Plan a Suitable Coding Production Line

For enterprises, UDI label printing needs to consider not only compliance but also actual production scenarios. Based on production line requirements and budget, design a coding solution suitable for your own production development. Coding methods can be divided into manual and automated, with various combinations of coding equipment.

Generally, for enterprises with low daily output and low automation levels that want to achieve compliance at low cost, manual coding can be adopted. In this case, simply use existing factory equipment, add a label printer with inspection function, relevant barcode scanning equipment, and a computer connected to the UDI service platform. Under the guidance of the UDI service platform implementation team, designated personnel can complete manual batch printing of UDI labels, manual data filling, and label verification.

For medium-sized, large, or enterprises aiming to improve automation, semi-automated or automated coding production lines should be considered. As daily output increases, the drawbacks of manual labeling become more apparent: low efficiency, high time cost, high labor cost, and high error rate. Generally, if a product's daily output reaches around 20,000 units, enterprises should start considering customized automated coding production lines, which require more equipment and higher automation levels.

3. Note Any Special Requirements

UDI coding involves policies, regulations, traceability codes, and high-read-rate barcodes. To ensure the readability of UDI, the print quality of UDI label barcodes must meet at least ISO15415 Class C standards, with higher requirements for some export products. Generally, coding equipment with a resolution of at least 300 dpi should be selected. If printing smaller QR codes, 600 dpi printing equipment should be considered.

In addition to correctly matching packaging materials and coding equipment, enterprises also need to confirm with local drug regulatory authorities or hospitals whether there are specific requirements for coding methods, or if designated coding methods are required. Additionally, pay attention to whether labels have special requirements such as low temperature resistance, waterproofing, alcohol resistance, and abrasion resistance.