Labeling Requirements for Medical Device Travel Case

#1
Hello,

This is my first post here, so apologies if this is not in the correct area.

My company currently purchases a third-party hard-cover travel case for our sales team to travel with the medical device. Currently we do not put any specific labeling on the travel case, as it has been used by in-house personnel only. Now a distributor we work with in the US has requested the same travel case, for use by their sales team to travel with the medical device. My question is:

If the case itself is not a medical device and is not the packaging for the medical device, what labeling are we required to place on the travel case? Are we required to then treat it like we would our other labeling and include things like: Manufacturer, manufacturer address, serial/lot number, manufacturing date, etc?

I ask because this travel case is a third-party product and we are not the manufacturer of it, so what information would we include? Ours or the Third-party? I feel like I am over-thinking this and that a simple SKU would be sufficient to track invoicing internally. There would be no customer use of the travel case and there is no medical performance for the travel case.

Thank you for your assistance!
 
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Zero_yield

No cost too great...for Quality
#2
The third party distributor will just be using this to carry a demo around, and you don't actually make the travel case?

As long as you're not using the travel case to distribute product for patient use, I would say it needs no special labelling. I'm assuming the travel case just looks nice, fits the device, provides a reasonable amount of protection, etc.

The only concern I can think of is if you were shipping it overseas with the medical device inside, you might need to declare it specifically for customs reasons.
 
#3
The third party distributor will just be using this to carry a demo around, and you don't actually make the travel case?

As long as you're not using the travel case to distribute product for patient use, I would say it needs no special labelling. I'm assuming the travel case just looks nice, fits the device, provides a reasonable amount of protection, etc.

The only concern I can think of is if you were shipping it overseas with the medical device inside, you might need to declare it specifically for customs reasons.
Thank you Zero_yield, so currently our sales team uses the case for the purpose you described. It looks nice, helps protect the device, and is easier to move around. Our sales team does not hand the travel case over to the customer, it remains in their possession.

However, this distributor we are working with would like to use the same case to bring devices into a customer to perform product evaluations. So in that case the line between "distribute for patient use" gets a little grayer. They will not be using the travel case to sell the product to the customer, however it sounds like the distributor will be using these to ship the device to the customer for lets say a 60 day trial period to evaluate the device.

Currently, we only work with this distributor in the US.
 

Zero_yield

No cost too great...for Quality
#4
OK, so I'm making some assumptions here that I'll try to be clear on:

-I'm assuming you're already compliant to 21 CFR 820 requirements.
-I'm assuming that as a part of your compliance, you have procedures for storage, handling, distribution, and installation (as applicable).
-So what I'm imagining is that you have a device that comes in a box. It has compliant primary labelling and secondary labelling. The packaging is appropriate for shipment and handling of the device.

I think this is the question you want to ask yourself: Is putting my box with my device in it in the case in any way going to alter the conditions I'm expecting during shipment? For most products, I'd expect that slapping it in a nice case is equivalent to or better than strapping it to a pallet. However, I don't know your product - maybe your product needs light, air flow, humidity, etc. If your sales team is already using this particular case, I wouldn't expect there to be a problem.

I would think the only "labelling" necessary would be anything your distribution team needs for internal records (i.e. making sure the right devices went to the right people). Again, this is in the assumption that you're taking a completed device, in its appropriate packaging, with its normal labelling, and sending it off in a fancy case.

CFR - Code of Federal Regulations Title 21

CFR - Code of Federal Regulations Title 21
 
#5
OK, so I'm making some assumptions here that I'll try to be clear on:

-I'm assuming you're already compliant to 21 CFR 820 requirements.
-I'm assuming that as a part of your compliance, you have procedures for storage, handling, distribution, and installation (as applicable).
-So what I'm imagining is that you have a device that comes in a box. It has compliant primary labelling and secondary labelling. The packaging is appropriate for shipment and handling of the device.

I think this is the question you want to ask yourself: Is putting my box with my device in it in the case in any way going to alter the conditions I'm expecting during shipment? For most products, I'd expect that slapping it in a nice case is equivalent to or better than strapping it to a pallet. However, I don't know your product - maybe your product needs light, air flow, humidity, etc. If your sales team is already using this particular case, I wouldn't expect there to be a problem.

I would think the only "labelling" necessary would be anything your distribution team needs for internal records (i.e. making sure the right devices went to the right people). Again, this is in the assumption that you're taking a completed device, in its appropriate packaging, with its normal labelling, and sending it off in a fancy case.

Thank you Zero_yield for your feedback! Yes, we have the appropriate labeling on our products and their normal packaging. As far as shipping our products do not need any specific shipping conditions that the travel case would be impacting.

In your final example, I think the only hurdle we need to address is determining with the plan was to ship the device(s) in the travel case with the normal packaging. My understanding was that the distributor wanted us to place the products into the case without the normal exterior package. Which in that situation the travel case becomes the exterior packaging and then would require product labeling on the exterior of the travel case.
 

Zero_yield

No cost too great...for Quality
#6
The situation is kind of on a weird, fine line. I don't really see what you're doing as remanufacturing or relabeling the device. I don't really see a regulatory reason to put formal labelling on the outside of the case (though it might be nice to put your logo on it for branding purposes, but that's besides the point).

For context, our company sells several kinds of consumables. So you can buy a box of A, a box of B, or a box of C. We also have a combo where you can buy packages of one A, one B, and one C. To manufacture the "combos," we take regular, full boxes of A, B, and C, break them apart, and recombine them into the combo boxes. So though product A in a combo is being shipped without its normal secondary labelling and carton, it still gets shipped in a controlled, traceable way in a different package it's validated to travel in. Even this seems much more extreme than what you're doing.

To be clear, I don't think there's necessarily anything wrong with throwing the product in the case and shipping it. Your sales team seems to be doing this all the time, apparently with no ill effects.

I think a conservative approach would be to formally document (maybe through your Change Control process) that the case provides the same protection or better than the normal box, the case does not alter or damage the device, all of the appropriate information is being given to the end user (directions for use / instructions for use) so there is no risk to the customer not receiving the carton, you are maintaining traceability through xyz, etc. Basically, show your work so if anyone questioned it later, you have a clear explanation of the suitability of the case for the task you are using it for, and any risks you identified have been mitigated.

Source on labelling:

Quality System Regulation Labeling Requirements
 
#7
The situation is kind of on a weird, fine line. I don't really see what you're doing as remanufacturing or relabeling the device. I don't really see a regulatory reason to put formal labelling on the outside of the case (though it might be nice to put your logo on it for branding purposes, but that's besides the point).

For context, our company sells several kinds of consumables. So you can buy a box of A, a box of B, or a box of C. We also have a combo where you can buy packages of one A, one B, and one C. To manufacture the "combos," we take regular, full boxes of A, B, and C, break them apart, and recombine them into the combo boxes. So though product A in a combo is being shipped without its normal secondary labelling and carton, it still gets shipped in a controlled, traceable way in a different package it's validated to travel in. Even this seems much more extreme than what you're doing.

To be clear, I don't think there's necessarily anything wrong with throwing the product in the case and shipping it. Your sales team seems to be doing this all the time, apparently with no ill effects.

I think a conservative approach would be to formally document (maybe through your Change Control process) that the case provides the same protection or better than the normal box, the case does not alter or damage the device, all of the appropriate information is being given to the end user (directions for use / instructions for use) so there is no risk to the customer not receiving the carton, you are maintaining traceability through xyz, etc. Basically, show your work so if anyone questioned it later, you have a clear explanation of the suitability of the case for the task you are using it for, and any risks you identified have been mitigated.

Source on labelling:

Thank you again for your insight and example. I like how you laid it out what you are doing at your company. In your example, doesn't the 'Combo Box' have a specific label on it to describe the products inside the 'Combo Box'? So, each product (A, B, & C) will have their normal product label on each device, then the 'Combo Box' itself will have a label on it I imagine.

Carrying that idea forward to my example, the device inside the Travel Case would have it's label on the device itself and instead of a cardboard box as the secondary package, wouldn't the Travel Case be considered the secondary package and require a product label (like your 'Combo Box')?
 

Zero_yield

No cost too great...for Quality
#8
You're right, the Combo Box has a label on it laid out like so:

Company Name
Product
SKU

Contents
[Company] Products:
1 EA Object A
1 EA Object B
2 EA Object C

Other Items:
1 EA Object D
10 EA Object E

Lot number, expiration date, bar code, relevant icons, etc.
The safest route would probably be to treat the travel case like a secondary package and put a secondary label on it.
 

Junn1992

Involved In Discussions
#9
agree, the case should be treated as shipping packaging, and your original packaging must be intact. As to how the distributor intends to deliver to the end user, this should be stated in your quality agreement somewhere. So if they do something funny, and the labelling is off, you have the QA to fall back upon. Also, i'm not sure for the US, but a change of labelling or packaging in the EU comes with it additional responsibilities as well on the part of the distributor.
 
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