The Medical Device Regulation (MDR) changed the requirements for OEM’s that serve the European medical market, increasing the quality and traceability of medical devices.
A key component of the MDR is Unique Device Identification (UDI) requiring permanent labeling for medical devices, to enable rapid product recalls within the supply chain – the information being stored in the European Database for Medical Devices (EUDAMED).
Reusable surgical instruments, subjected to repeat autoclave cycles, represent a major challenge with regard to “permanently legible labeling”.
As a major supplier of connectors and assemblies for medical technology, ODU offers laser marking in accordance with UDI. Connectors (both metal and plastic) are marked by a cold-process, ultra-short-pulse, fibre-optic laser – without being subjected to thermal or mechanical influences.
Since the surface structure remains unchanged, the product can be kept clean and sterile. The markings remain permanently legible – even after the specified maximum number of autoclave cycles and are also resistant to acids, cleaning agents, and bodily fluids.
“We implement UDI by laser marking our plugs, but at ODU we also focus on other product-related medical topics, such as patient and user protection, and implement them in compliance with IEC60601-1” says Mathias Wuttke – Business Development Manager for the Medical Technology division.
In a complex process, the area in which the wires enter the connector can be moulded with silicone, resulting in a perfectly sealed yet flexible connection. This over-moulding does not peel off or become detached, even after the required number of autoclaving cycles (steam sterilization at up to 134°C and 3,040 mbar) – its biocompatibility is cytotoxicity tested (outgassing) to DIN EN ISO 10993-5 which is confirmed by an external testing laboratory.
Satisfied customers are the primary focus for ODU, so we support our customers in:
- End-to-end risk and change management
- Seamless traceability of materials and productions
- Consideration of the requirements in the supply chain
- Reporting requirements for CMR substances
- Extended retention periods for documentation