1. UDiBar Introduction
Unlike traditional ways to establish UDI (Unique Device Identification), UDiBar is a UDI generator and label management system helping medical device manufacturers to establish a comprehensive UDI management system that meets the requirements of QMS and ISO 13485 in a short time.
Its functions include automatic generation of compliant UDI barcodes (EAN13, GS1-128, Data Matrix), tracking and management of UDI labels and barcodes, and a complete database that can be viewed and traced at any time. It also provides operation instructions and 3Q validation templates. Besides, UDiBar offers a correspondent format to submit to different national databases.
WhaleTeq further provides software partners with an Application Program Interface (API), which enables UDiBar to connect and work with ERP, MES, and more. TPP (Technology Partner Program) can assist software system integrators to provide more complete solutions to medical device manufacturer customers.
2. UDiBar System Structure
3. Features and Benefits of the UDiBar
- ● Easy to use: with a simple user interface
- ● One-stop management, saving costs
- ● Compliant with 1D, QR code and EAN 13
- ● Product traceability records, effective management and tracking system
- ● Support multi-device connection, improve working efficiency
- ● Support docking with ERP system to reduce human error
- ● Bar code sampling inspection to confirm the quality of barcode printing
- ● Support label editing and import base map, automatically import changing information
- ● Provide database file format
4. What is UDI?
UDI is a unique device identification system to identify medical devices from manufacturing, distribution to patient use. As summarized on the US FDA’s website, it requires device labelers, typically the manufacturer to:
● Include a unique device identifier (UDI) on device labels and packages.
● Submit device information to correspondent national database: GUDID for the U.S.A., EUDAMED for EU, TUDID for Taiwan, etc.
● UDI includes:
- DI: Device Identifier, a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
- PI: Production Identifier, a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device: lot or batch number within which a device was manufactured, serial number, expiration date, date of manufacturing.
The device labeler must provide the UDI in two forms on labels and packages: easily readable plain-text and machine-readable form that uses automatic identification and data capture (AIDC) technology.
5. Challenges in Establishing an UDI System
● Tight Schedule: In 2013, FDA announced the necessities of establishing UDI. In Taiwan, the government has followed up international trends, and UDI was introduced to <<Medical Device Regulation>> from last year. In 2023, all class II & III medical devices should contain UDI barcodes and labels.
- ● Time-Consuming Cross-Functional Communication: It takes all departments including legal, production technology, IT, and production department to communicate all the details of the UDI requirements, SOP, and creating a database to manage UDI.
- ● Difficulties in Platform Integration: To establish UDI, several different tools are needed, and below are all the essential steps to complete the UDI setting: DI editing, digit checking on GS1 website, saving DI information in csv form, adding PI information manually, copying UDI to barcode editing software to edit, printing out UDI labels.