UDI (Unique Device Identification) Transition Period - Packaging Labeling

Pmarszal

Pmarszal

Involved In Discussions
Is there any foreseeable issues to label a Package of 5-units package with UDI even though we are shipping 5 individual units not labeled with the UDI barcode (manufactured before Sept. 24th)?

We would like to implement the package labeling right away and was wondering if there is any issues with this?
 
Q

QA-Man

I am not exactly sure what you mean but you don't have to label products with a UDI that were manufactured before a UDI deadline.

So if it is class II and doesn't fall into a category with an earlier deadline (like "life-supporting) you don't have to label it with a UDI if it was made before 2016-09-24.
 
Pmarszal

Pmarszal

Involved In Discussions
QA-Man! You have been of great help!

I understand that items manufactured prior to the deadline is an exception and we are not re-labeling these parts.

What my question is if it poses any issues if we label the package label with UDI (which we do at the time of shipment) even though the individual parts in that shipment are not labeled with UDI (because the parts were manufactured prior to deadline)?
 
Q

QA-Man

If they're single use and one in a box, no UDI required at all. No problem

If you're not lucky enough for this to be the scenario, I would still say no problem. Many companies have had all sorts of barcodes on all sorts of packaging levels before UDI that look just like UDI's. You're just another company who chose to barcode their product as they saw fit before being required to do it in a particular way.
 
Ronen E

Ronen E

Problem Solver
Moderator
I'm also not aware of any reason why you shouldn't do what you plan. Moreover, my interpretation is that you actually should UDI-label the 5-packs even though the individual devices inside are exempt, if packaging of the 5-packs occurs after the Compliance Date. Packaging is a manufacturing step, if the package is a retail one. Even if it's a shipping / wholesale package, it might be seen as a manufacturing step if it's the only shipping packaging layer and done by the original device manufacturer - your company (i.e. not by a distributor etc.).

Added in edit: Shipping cartons are generally exempt from UDI marking, so maybe it's not such a clear cut. It depends on the nature of those 5-packs. Sorry if I misled anyone.
 
Last edited:
M

missjenny

For what it's worth, I second Ronen's take as well.

Apologies for the lazy reply, but I have nothing more to add to Ronen's reply other than to agree with it.
 
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