Hi Anon,
First, some questions:
- Do you move just the production site, or does your legal manufacturer address change as well?
- Where are products placed on the market? Europe, US, or somewhere else? I can only speak for the European market...The approach might be different somewhere else.
- What risk class is your device? In other words: is a notified Body involved?
If you just move production, you have the inform your Notified Body (Major change in QMS). The production site must then be included in your ISO 13485 Certificate (your NB will propably audit the new site for this). Once the site is included in your certificate, you can produce there. To my understanding, you would not have to change the address on the label in this case.
If you move the whole company, including legal manufacturer address, you have to inform your Notified Body as well. Your Certificate must be updated.
I think changing the address prior your move is walking on a very thin line. You have to make
very sure that the new devices won't be brought to market until after the move. I would not recommend it.
Regards,
Britta
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Britta Cyron
Bochum
Germany
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Original Message:
Sent: 01-Feb-2021 16:26
From: Anonymous Member
Subject: Labeling with new address
This message was posted by a user wishing to remain anonymous
We are moving our manufacturing location, projected in Q4-2021. The phone numbers, emails and website address are not changing - only the address. We will be assembling products prior to the move that will not be sold until after the move. Can we start labeling the product with the new address prior to the move, since the product will be sold after the move so that we don't have to re-label after the move?