Hi All,
Where does a medical device manufacturer stand when a customer asks them to permanently print information specific to their facility onto the device label or the device itself during manufacturing. Should the manufacturer just tell the customer to affix whatever labels they wish after they've purchased or fulfill their request, and if so does the associated technical file need to be amended, and worse case scenario for class II and above be resubmitted for CE mark.
Jo
Where does a medical device manufacturer stand when a customer asks them to permanently print information specific to their facility onto the device label or the device itself during manufacturing. Should the manufacturer just tell the customer to affix whatever labels they wish after they've purchased or fulfill their request, and if so does the associated technical file need to be amended, and worse case scenario for class II and above be resubmitted for CE mark.
Jo