A
To all,
I am interested in knowing if there are any published guidelines on mutual recognition by Notified Bodies, e.g. if you leave one NB for a second one, will the second NB “automatically” accept all the QS and product certifications of the first NB.
Another question concerns own branding or private labeling: Company “A” buys an OEM medical device from company “B”. Company “B” received CE approval from its NB for the device. Company “A” will only change the device label and labeling as the legal manufacturer. Will Company “A” need to submit a full CE Technical File to its NB for review, or only the changed labeling (since the CE Technical File of Company “B” has already been approved by a NB)?
Thanks.
Asherlee.
I am interested in knowing if there are any published guidelines on mutual recognition by Notified Bodies, e.g. if you leave one NB for a second one, will the second NB “automatically” accept all the QS and product certifications of the first NB.
Another question concerns own branding or private labeling: Company “A” buys an OEM medical device from company “B”. Company “B” received CE approval from its NB for the device. Company “A” will only change the device label and labeling as the legal manufacturer. Will Company “A” need to submit a full CE Technical File to its NB for review, or only the changed labeling (since the CE Technical File of Company “B” has already been approved by a NB)?
Thanks.
Asherlee.