Medical technology industry

Medical devices are subject to strict marking regulations in the European Union and the USA. In both regions, medical products and devices have to be marked with a UDI. UDI stands for Unique Device Identifier. In the EU, the exact rules for UDI marking are defined in the Medical Device Regulation (MDR) 2017/745. Since 2021, manufacturers, distributors and importers of medical devices have to implement this unique device identifier in stages. By 2027, medical devices of all hazard classes and their packaging will have to bear the UDI marking as a 1D Code or 2D Code and in plain text. This is intended to further improve traceability, counterfeit protection, product safety and ultimately patient safety.

Whether hip prostheses or dental implants, surgical instruments or insulin pumps, bandages or care beds: the marking technology used to ensure that the UDI and other markings on medical devices are easily accessible and permanent depends on the material and the specific application of the medical device.

Challenges with markings for medical technology

• Very strict normative labeling requirements (MDR 2017/745)
• Ensuring optimal readability and contrast on a permanent basis
• A lot of information on sometimes very small areas
• Ensuring forgery-proof and patient safety
• Serialization / Track & Trace

Which materials and products are marked in medical technology?

A wide variety of devices and products made of metal, stainless steel, plastic, glass, textiles, among others:

Non-woven material: ^Tyvek®, dressing material, respiratory masks
Surgical cutlery/surgical instruments: scissors, tweezers, scalpels
Operating rooms: operating room equipment, surgical textiles
Implants: Hip joint implants, knee joint implants, dental implants, pacemakers
Prostheses: Arm prostheses, hand prostheses, foot prostheses, leg prostheses
Care aids: wheelchairs, care beds, walking aids
Contact lenses: lenses, contact lens cleaner
Cannulas, syringes
Dialysis machines
Ultrasound equipment
Diabetes aids: insulin pens, insulin pumps, sugar measuring devices
In vitro diagnostics

Where are our solutions used?

• UDI marking with laser systems
• Marking medical technology packaging with ink
• Creating UDI labels
• Serialization for seamless traceability
• Sealing labels for first-opening protection (Tamper Evident)
• Verifying and checking