Basic UDI and UDI-DI for hip implant systems

[ab1992]

Hello all,

I'd like to ask for some help/advice trying to figure out basic udi and udi-di's for a hip implant acetabular system. The various components (shells, liners, femoral heads, associated instruments) all have their own UDI-DI. Presumably each type of component would need to have it's own basic udi-di due to differences in manufacturing characteristics, intended use etc? Or would the acetabular system just need to have a single basic udi, covering all of those separate components?

The acetabular system has a single technical documentation file under MDD with a separate technical documentation file covering the reusable instruments and this plan would be the same for EU MDR.

 

[sibelyum]

Hello,
All components with different production processes and different usage purposes must have the basic UDI-DI code separately.
Each technical file does not have to have a single basic UDI-DI code, it is necessary to evaluate each component of the product separately and derive the code.

I wish you success in your work.