The scenario...we have a Class I FDA device. We are running low on inventory in EU and want to transfer from our USA distributor to the EU distributor. Although we are the HQ, we are strictly a design/devel site (product is manufactured globally.) The final packaging consists of the device itself, an accessory (which is expring soon), IFU.
The proposal...Bring product from USA distributor to our site, change the labeling for EU, replace the accessory with a current one, update the CEMarking labels.
Would this be considered a recall? Also, can we perform the activities listed at our site or would this be considered a "manufacturing" activity?
Many thanks for the guidance.
First, when you say, "our site", are you indicating that you are the EU distributor? You said that you're company designs the device, and it's manufactured elsewhere, then distributed.
This is definitely a manufacturing activity. The device isn't distributed yet. It's stored for distribution at the US distribution facility.
You've made a business decision to move inventory. There is no requirement other than the typical storage, handling, distribution requirements that would apply here.
You want to alter or refit devices that have already been manufactured, and it's unclear to me whether you want that activity performed at the EU distributor or at the design / development establishment.
In either case, treat this as a manufacturing process. Enter the inventory into the system as a "re-work work order" or whatever you call it at your company. If your company doesn't manufacture anything, you probably won't have such procedures. I would recommend documenting it either as a new process or enter it into your CAPA system, or have your manufacturer handle the rework. They should be equipped to handle rework work orders.
There are just a handful of Class I devices that might require a little more control than this. As stated by others, just be sure that your device meets the requirements of the MDD and CE mark.
I don't see this as a removal because the device has not been distributed. The inventory may have been sold to a distributor, but it's not distributed yet. In this case, you'd simply be buying your inventory back from the distributor.
Without knowing whether any special controls apply to your device, though it's not really possible to recommend a solid strategy.
Chris Ford