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Addition of Design & Manufacture - CE Mark Reissue?

#1
Consider a medical device software company, after having a CE-mark certificate and ISO 13485.
If the company adds a new location for design and manufacture, while mantaining the legal mafacturer address (same existed in the original certificate) would they be required to re-issue the certificates to add the new location?
 
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somashekar

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#2
Consider a medical device software company, after having a CE-mark certificate and ISO 13485.
If the company adds a new location for design and manufacture, while mantaining the legal mafacturer address (same existed in the original certificate) would they be required to re-issue the certificates to add the new location?
I would consider adding the new location and discuss with my NB in advance the dates and modalities, to include in an annual audit, and to avoid any special audit for the addition of location.
 
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