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Basic UDI and technical documentation

#1
I seek some clarity regarding Basic UDI, UDI-DI and how the technical documentation will be compiled. Apropos to MDR, Basic UDI will be assigned to a group of products with similar intended purpose, risk class, manufacturing characteristics etc. UDI-DI on the other hand, will be assigned to each model/version of that product group. Multiple UDI-DI can be assigned under one Basic UDI. As per my understanding, this works as followed:
Basic UDI for bipolar forceps
UDI-DI 1: Single use sterile bipolar forceps
UDI-DI 2: Reusable non-sterile bipolar forceps
UDI-DI 3: Single use non-sterile bipolar forceps
If the above example is correct then making Basic UDI as base, can we develop one technical file of bipolar forceps and in it cover all types of bipolar forceps for which we have assigned separate UDI-DI (Single use, Reusable, Sterile, Non-sterile). We used to develop separate technical files of the said product in single use and reusable state under MDD.
I posted same question in another thread as well but couldn't get an answer. Hopefully someone can help me see through it.
 

indubioush

Quite Involved in Discussions
#2
If the above example is correct then making Basic UDI as base, can we develop one technical file of bipolar forceps and in it cover all types of bipolar forceps for which we have assigned separate UDI-DI
Seems to me it would be messy to have one file. You have different intended uses, risk profiles, labels. Why have one file? It is possible to share certain documents among the files.
 
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