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What are the implications of MDR?
The directive aims to increase the quality and traceability of medical devices. Traceability is to be given by a UDI. What is UDI? The UDI is the Unique Device Identification and thus the permanently legible labeling of medical devices. The traceable UDI code is intended to enable rapid recall within the supply chain, and the relevant information is stored centrally in EUDAMED. For reusable surgical instruments, the eventual multitude of autoclaving cycles presents a challenge.
How does ODU label the products in a permanently legible way?
With laser marking (s. image), the ODU connector (possible for metal and plastic) is structured by an ultrashort pulse fiber laser without thermal or mechanical influence.
The surface structure remains unchanged, so the product can be kept pure and sterile.
How durable is the laser marking?
The markings are permanently legible due to the corrosion resistance, viewing angle stability and structuring - even after the possible number of autoclaving cycles. The laser markings are also resistant to acids, cleaning agents, and bodily fluids.
How does ODU help me implement MDR in general?