What is the UDI code exactly?
The UDI code is a worldwide identification system for medical devices. It improves the quality of care, patient safety and your business processes. In addition, this code limits the risk of counterfeiting of medical devices and makes a possible recall of defective products faster.
When is a UDI code necessary?
Medical devices are divided into different classes, namely: class I, II and III. For devices in the highest class (III), the deadline for a UDI code has already expired on May 26, 2021. The deadlines for medical devices from class II and I will follow in 2023 and 2025. However, for all devices, regardless of the risk class, that a UDI must already have been assigned from May 26, 2021. It must correspond to the corresponding item data recorded in the European Database for Medical Devices (EUDAMED).
What does the UDI look like?
The UDI is a unique numeric or alphanumeric code and consists of two parts:
1. Device Identifier (DI): The DI is actually nothing more than a uniform item code. It is a mandatory part that uniquely identifies the device. This unique product number is the Global Trade Item Number (GTIN).
2. Production Identifier (PI): The PI stands for all information related to the production process. This is a variable part of the UDI that is added to the code only for high-risk products. The PI only contains data that is written on the label:
Lot/batch number, expiration date & serial number.
You place the UDI on the product both in text form and in symbol. This can be done with a GS1 DataMatrix or a barcode (GS1-128).
Printing the UDI code?
With all our systems it is possible to easily provide your medical products with UDI codes. Depending on your production process, you can opt for labelling, desktop printers, small character inkjet, high resolution inkjet, foil coding or laser coding.
