INTEGRATED LABELING SOLUTIONS FOR MEDICAL TECHNOLOGY
Clearly identifiable and traceable: To ensure this for medical devices, the prescribed codes can be applied by label. We offer the medical technology industry integrated, automated labeling systems for this purpose.
Making medical technology identifiable
LABELING ON MEDICAL DEVICES AND PACKAGING
For complete traceability in accordance with the Medical Device Regulation (MDR), two parts of the UDI marking have to be applied to every medical device and every packaging unit: the Device Identifier (DI) and the Production Identifier (PI). The DI is a static code with around 20 pieces of data on the manufacturer and product. The PI contains variable data for traceability such as the batch number, serial number and expiry date. The unique UDI code is assigned by one of the four defined allocation bodies GS1, HIBCC, ICCBBA and the Information Center for Proprietary Medicinal Products. All medical devices are also stored with their master data and UDI code in the EU database EUDAMED. The master data and information on the medical device can be called up at any time. The UDI marking requirement will be gradually introduced for all medical devices in the EU by 2027, depending on the risk class to which a medical device belongs.
A UDI label for the serialization of medical devices has to contain two parts of the UDI code: the Device Identifier (DI) and the Production Identifier (PI). While the DI contains static data on the manufacturer and product, the PI consists of variable data such as serial number, batch number and expiry date. Both elements of UDI are to be printed on the label as machine-readable 1D or 2D Barcodes and additionally in plain text for the user. The unique UDI marking is assigned in the EU by one of the four allocation bodies GS1, HIBCC, ICCBBA and the Information Center for Proprietary Medicinal Products. The UDI code and the master data of all medical devices are stored in the EU database EUDAMED. The information on the product can be called up there at any time using the UDI code. The UDI marking requirement will be gradually introduced in the EU for all medical devices by 2027, depending on the risk class to which the medical device belongs.
What needs to be considered for labeling solutions?
- Legal requirements in accordance with Directive MDR 2017/745 and IVDR 2017/746
- Error-free serialization
- Machine-readable 1D Barcodes and 2D-Matrix-Codes
- Fast, economical application
- Good adhesion, permanent readability
- Often a lot of information on a small area
Industrial labeling solutions are used throughout the medical technology sector. Labels are applied to medical products themselves, but also to secondary packaging at all packaging stages. They support seamless traceability and patient protection in the medical technology sector.
Application examples of our labeling solutions
- Marking of packaging material with ink
- Labelers integrated into production lines for secondary packaging
Anyone wishing to place medical devices on the market in the EU has to comply with the Medical Device Regulation MDR 2017/745. Among other things, it regulates the unique product marking by code and plain text on medical devices and their secondary packaging using Unique Device Identification (UDI).
The Medical Devices Regulation divides products into three risk classes. The implementation deadlines for UDI marking are based on these. Implants and medical devices in risk classes III (high risk), devices in classes II a (medium risk) and II b (increased risk) have had to be marked since May 2021 and May 2023 respectively. For other medical devices in classes II and I (low risk), the labeling requirement will apply from May 2025 and May 2027 respectively.
