Review of Requirements related to the Product (7.2.2)

G

Ge-hS

#1
Hi,

We are the OEM for Class I and Class IIa devices. A few of our customers have requested Private Labeling and that we perform the packaging and labeling of their devices at our facility. (The devices will be sold on the market under their name, not ours.)

When I read 7.2.2, it appears that I should not accept an order from a customer for a Private Labeled product until after we have come to an agreement on the packaging and labeling of that product.

Am I interpreting this too literally?

I had a pretty heart-pounding discussion about this the other day and if I am wrong I'd like to repair the damage quickly.

Can you share with me how you meet this requirement in similar situations?
 
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M

MIREGMGR

#2
Re: Review of requirements related to product

The company for which I work has many private label customers, under both US FDA and EU MDD approaches. Sure, your reading of 7.2.2 is formally correct, but in my view it's reasonable to allow a little leeway in the detailed sorting out of the packaging and labeling specs as a matter of practicality.

One way to handle that is to agree with the customer at order acceptance time that the packaging and labeling specs will be per your existing specs but with their identifying info substituted, unless changed with mutual approval. You already know that you can meet those specs, so you pass contract review.

I.e., you take the order today, you put the order into your production system tomorrow, and the packaging and labeling specs (which typically are only applied after production is done) get sorted out before they're needed. When they're sorted out, you do a memo of understanding that modifies the original agreement, and you show in your records that you've contract reviewed the modified specs and can meet them.
 
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