Address change for a company with CE/ISO13485

#1
Hi Forum,

We are a small company with CE approval (MDD) and EN ISO13485 and we are not selling or plan to sell in the next 12-16 months.
We have our first surveillance audit by our NB soon. About 1 month after this planned audit we will move our office and manufacturing site to another location within the same city.
I have already informed the NB about the move and that (i) we are not selling nor plan to sell, (ii) there is no effect on the TF except documents that are relating to address (e.g. labels and IFU) and (iii) we plan to complete the production line qualification during H2 of 2021.
Our NB requires to proceed with the audit as planned and then, after the address change, that we submit our Technical File and have a Phase 1 (Documentation review Address Change: QMS + TF) and of course to pay again for re-issuing both certificates with the new address.

This seems to me like an excessive and unreasonable requirement and i'll appreciate if you can share your experience or any suggestion .
 
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#2
Why does this seem excessive/unreasonable? Moving to a new facility is a very big deal. The NB must check that there are no adverse effects on the product resulting from the move. And of course your certs must have the correct address.
 
#3
Hi Forum,

We are a small company with CE approval (MDD) and EN ISO13485 and we are not selling or plan to sell in the next 12-16 months.
We have our first surveillance audit by our NB soon. About 1 month after this planned audit we will move our office and manufacturing site to another location within the same city.
I have already informed the NB about the move and that (i) we are not selling nor plan to sell, (ii) there is no effect on the TF except documents that are relating to address (e.g. labels and IFU) and (iii) we plan to complete the production line qualification during H2 of 2021.
Our NB requires to proceed with the audit as planned and then, after the address change, that we submit our Technical File and have a Phase 1 (Documentation review Address Change: QMS + TF) and of course to pay again for re-issuing both certificates with the new address.

This seems to me like an excessive and unreasonable requirement and i'll appreciate if you can share your experience or any suggestion .
It isn't unreasonable and for each country you hold a registration in you basically have to go through the same thing: registration (new or modified), update all labels, IFU's and Declarations (DoC). AND expect to pay for a one day surveillance audit as well. Can you put off your first audit until after your move? It could save you money.
 
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