UDI-PI for IVDs used in house

Alan_DB

Involved In Discussions
#1
Hi all,

I work for an IVD manufacturer where we exclusively use our own product in house. Our customers contract us to perform testing on samples sent to us via courier.

My background is Med Device so IVD is a little different for me, especially given the set up of the business. My question is around UDI-PI. (I'm 100% with UDI-DI).

We manufacture a range of buffers, reagents and agarose gels. I'll repeat, we do not sell these individually, they are all used on site on our own lab. I'm struggling to define what constitutes our production identifier. We give every sample we receive a unique number to identify it and that is tied to our testing records where full traceability is maintained. The unique number is allocated in a controlled manner, akin to a serial number. Would this be sufficient to claim as our UDI-PI if we control our testing documentation where this is documented as labelling?

Any help appreciated!!
 
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yodon

Leader
Super Moderator
#2
I'm a bit confused. You say you ID the samples - those sent from the customer? Those would not be (part of) the device so they wouldn't factor into the UDI.

Your devices are "standard issue" (in that you don't customize a device per sample received)?
 

Alan_DB

Involved In Discussions
#3
I'm a bit confused. You say you ID the samples - those sent from the customer? Those would not be (part of) the device so they wouldn't factor into the UDI.

Your devices are "standard issue" (in that you don't customize a device per sample received)?
Apologies, each test (using customer supplied sample) is given a unique ID that is documented on the paperwork to go with that test.

Yes standard issue, no customisation.
 

yodon

Leader
Super Moderator
#4
Apologies, each test (using customer supplied sample) is given a unique ID that is documented on the paperwork to go with that test.
Ok, then that would have nothing to do with the UDI.

Yes standard issue, no customisation.
The DI part is just the 'base' identifier ("this is my widget") and the PI part is whatever else info is relevant (lot / serial number, date of manufacture, etc.).
 

Alan_DB

Involved In Discussions
#5
I have electrophoresis gels, buffers and reagents all manufactured individually with different shelf life, when used in conjunction with each other constitute our test. So I am at a loss what I can assign a UDI-PI to except each individual test performed.

Its pretty difficult to interpret when we don't actually ship anything to a customer / end user. So we also have no packaging and the only labelling is the IFU.
 

Billy Milly

Involved In Discussions
#6
I think you should define those as separate processes: 1. Production (already solved, as you describe); 2. Service - performance of testing. In first case, you are the manufacturer, in second, you are the user - consumer. PIs should be assigned to the individual products you produce to use for testing further on.
 
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