Laser coding and marking solutions for medical devices
Patient safety is the top priority. Clear, permanent and forgery-proof marking is therefore mandatory for dressings, syringes, diabetes accessories and many other medical devices. With our laser coding and marking systems, we have proven, integrable solutions for this.
Marking medical products for traceability
LASER CODING AND MARKING SOLUTIONS FOR MEDICAL TECHNOLOGY
Two EU directives specify how medical devices, including in-vitro diagnostics, must be marked: the Medical Device Regulation MDR 2017/745 and the IVDR 2017/746. The two regulations are intended to ensure that medical devices are fully traceable and thus better protect patients. The MDR and IVDR therefore require each medical device to have a unique device identifier (UDI): on the device itself, on the primary packaging and on each subsequent packaging stage. This UDI marking has to be affixed in such a way that it is easy to read in the long term and is just as accessible when the medical device is used in practice as it is in the warehouse.
This is what the UDI marking for medical technology contains
The Medical Device Regulation (MDR) requires two parts of the UDI marking not only on every medical device, but also on its packaging units to ensure complete traceability: the Device Identifier (DI) and the Production Identifier (PI). As a static code, the DI contains around 20 pieces of data on the manufacturer and product. The PI is a variable code with batch number, serial number, expiry date and other variable data for traceability. The four defined allocation bodies GS1, HIBCC, ICCBBA and the Information Center for Proprietary Medicinal Products are responsible for assigning the UDI marking. The master data and information on a medical device can be accessed at any time via the EU database EUDAMED. All medical devices are also stored there with their UDI code. The EU is gradually introducing the UDI marking requirement for all medical devices by 2027, depending on the risk class to which the device belongs.
What makes laser coding and marking solutions stand out?
- Legal requirements in accordance with Directive MDR 2017/745 and IVDR 2017/746
- Avoid errors during 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 laser 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 laser marking and inkjet printing 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. Surgical cutlery, for example, is used repeatedly and has to be sterilized. Permanent marking using a fiber laser is a suitable choice for this.
Application examples for medical device marking
- Direct Part Marking (DPM) of medical devices by laser
- Printing 1D Barcodes, QR codes, central pharmaceutical number (PZN) and plain text on secondary packaging
- UDI marking of insulin pens using a laser system
- UDI coding of pacemakers
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 via 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.
