Informational EU – Eudamed Data exchange services and entity models introductions

Kim B

Starting to get Involved
Hello, In search of the EUDAMED UDI character structure, is it in the same format as FDA UDI? Unable to locate an image as to the format. Reaching out for advice. Thanks!
 

Ronen E

Problem Solver
Moderator
Hello, In search of the EUDAMED UDI character structure, is it in the same format as FDA UDI? Unable to locate an image as to the format. Reaching out for advice. Thanks!
Have you studied all the MDR's UDI clauses and the guidance by MDCG? There's quite a lot of detail in there.
In general the EU UDI is not harmonized with the FDA's, which I think is a real shame.
 

M.R.Falco

Starting to get Involved
Hello, In search of the EUDAMED UDI character structure, is it in the same format as FDA UDI? Unable to locate an image as to the format. Reaching out for advice. Thanks!

Hello! I stumbled across your question while looking for something else. Not sure if you found your answers or not, but if you are using GS1 I found this useful site posted by GS1 which includes a reference guide on how the Basic UDI-DI number is created and it also has a check digit calculator. Thought you might find it handy!

GS1 Model Number for UDI in the EU | GS1 Mauritius
 
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