EU Basic UDI-DI Trigger Points - When is a new Basic UDI-DI required

M.R.Falco

Starting to get Involved
#1
Hello everyone! I have a question about the EU Basic UDI-DI and how one determines when a new Basic UDI-DI is required. In my research I have learned that the Basic UDI-DI is essentially a higher level key for a group of similar products, but at what point do you decide to start a new Basic UDI-DI? Reviewing MDCG 2018-1, it is not clear what the requirements are and this document isn't overly helpful to us.

To give you an example, if I have a series of blood pressure devices, they might come in a variety of colors and cuff sizes. Generally devices like this would be extremely similar to one another as they all need to meet the same performance characteristics and have the same intended use, but there are differences between wall mounted devices, mobile-stand mounted devices, and hand held devices.

In this sort of situation, where do I put break points in my Basic UDI-DI? Are all the blood pressure devices one Basic UDI-DI since they are all the same risk class with the same intended use? Should I make three Basic UDI's, one for each type of mount/transportability option? Do I need to make more to account for cuff size differences? Do I need to go further and make one for each color option for each type of blood pressure device? Obviously we will continue to assign the actual UDI-DI to each and every variation, but the higher level Basic UDI-DI is a bit of a mystery.

Curious to see how others are handling this! I reviewed the GS1 guidance and it tells me how to create the Basic UDI-DI, but not how many I need to make! :)
 
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fialor

Involved In Discussions
#2
Hello Falco,
I have not had the question as my products so far has been pretty straightforward for Basic UID-DIs.
My suggestion would be to refer to the four key areas of consideration: Intended use, Risk class, Essential design, Manufacturing characteristics, and determine the extent to which they are different. Then draw a conclusion with a strong rational and be prepared to defend that position.
Your NB will also be able to shed some light on this for you. I hope it helps.
 

kreid

Involved In Discussions
#3
The picture attached indicates with asterisks what data item changes provoke a change in UDI (basic or otherwise).
However, I do find this all very vague and think there are probably more guidelines to come especially with regard to Basic UDI
 

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M.R.Falco

Starting to get Involved
#4
Thank you both for the advice/tips! I will consider these points when trying to decide the Basic-UDI break points in our database. Hopefully they clarify this further with guidance documents in the months to come.
 
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