Inkjet coding and marking solutions for medical devices
Patient safety comes first. This is why dressing materials, surgical instruments, insulin pumps, syringes and many other medical devices have to be marked clearly, permanently and forgery-proof in accordance with certain standards. Our injector coding and marking systems offer tried-and-tested, integrable solutions for this.
Clearly marking medical devices
INKJET CODING AND MARKING SOLUTIONS FOR MEDICAL TECHNOLOGY
Two EU directives are central to the marking of medical devices, including in-vitro diagnostics: the Medical Device Regulation MDR 2017/745 and the IVDR 2017/746. These are intended to ensure the complete traceability of medical technology for the protection of patients. According to the MDR and IVDR, medical devices have to bear a unique product identifier on the product itself, on the primary packaging and on all further packaging stages. The so-called UDI marking must be affixed in such a way that it is permanently readable and accessible both in the warehouse and during practical use of the medical device.
The UDI marking for medical devices
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.
What is important for inkjet coding and marking 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, simple and economical coding and marking technologies
- Permanent and durable marking
- Often a lot of information on a small area
Industrial inkjet coding and marking solutions are used throughout the medical technology industry. The Medical Device Regulation (MDR) allows marking with the UDI code as direct marking by inkjet printing and laser marking or by label. When selecting the printing process, the size of the printable area, the material to be printed and the application of the medical device must be taken into account.
Application examples of our coding and marking solutions
- Marking respiratory masks using an inkjet printer
- Direct Part Marking (DPM) of medical devices using inkjet
- Printing 1D Barcodes, QR codes, central pharmaceutical number (PZN) and plain text on secondary packaging
- UDI coding of pacemakers
Discover the wide range of marking and labeling solutions for medical devices and their secondary packaging. Our innovative inkjet coding and marking solutions contribute to their clear identification and traceability.
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, this 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.
