Mutual Recognition by Notified Bodies

A

Asherlee

#1
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.
 
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R

Roland Cooke

#2
Mutual recognition is pretty strong but (at least in our case) it is never simply blind acceptance.
 

Michael Malis

Quite Involved in Discussions
#3
...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.
Asherlee,

1. While recognition is exists, you still have to go thru review process...
2. If Company A buys OEM (from Company B or direct) - you still need to submit a TF with the right labeling as the Legal Manufacturer...

I hope this helps,
Mike
 

Peter Selvey

Staff member
Super Moderator
#4
Hi all,

There is a NBOG document which covers change of Notified Bodies, found at:
http: //www. nbog.eu/resources/NBOG_BPG_2006_1.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS

The NBOG series is an EU commision approved series of guides intended to replace the un-approved by government NB-MEDs.
 
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