Recommendations for Own Brand Labeling Notified Bodies for Medical Devices

DannyK

Trusted Information Resource
#1
Any recommendations for Own Brand Labelling notified bodies for medical devices?

Can the OBL audit be performed offsite with the transfer of files ?

I appreciate any help.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Any recommendations for Own Brand Labelling notified bodies for medical devices?

Can the OBL audit be performed offsite with the transfer of files ?

I appreciate any help.
Hi,

Not sure what you're looking for - are there NBs around the "specialize" in OBL? And why would an "OBL audit" be any different to a "normal" medical device audit (i.e. do different requirements apply)?

This document would probably be of little help, but FWIW:

http://www.mhra.gov.uk/home/groups/es-era/documents/publication/con007500.pdf

Cheers,
Ronen.
 

DannyK

Trusted Information Resource
#3
OBL audits are not very common in Canada.
Not all CE auditors are aware of the process.
I was hoping to find an NB that would be able to perform the audit remotely since the awarding of the certificate is based on the original manufacturer certificate.
There are documentation requirements ( procedures) for the OBL that could be transferred to the auditor.
 
R

Roland Cooke

#5
According to this webpage, SGS (no affiliation here) seems to be offering the sort of service you're looking for:

http://www.sgs.com/en/Life-Sciences...udit-and-Verification/Own-Brand-Labeling.aspx
Yes, we do a fair few OBL certifications. There are provisions for performing these offsite, but it's on a case-by-case basis as you can imagine.

Drop me an email, and I can put you in touch with the relevant SGS staffer.

Admin Note: See Roland's Profile for Contact Information. Roland has been around here for quite a while and is pretty much a trusted member here.
 
Last edited by a moderator:

somashekar

Staff member
Super Moderator
#6
Any recommendations for Own Brand Labelling notified bodies for medical devices?

Can the OBL audit be performed offsite with the transfer of files ?

I appreciate any help.
A good approach is to work with the same NB as of the original manufacturer, however this is not a requirement. If you have your own NB for your other products, then they can help you and they will bank on the original manufacturer's NB certificate, with an offsite audit of required OBL systems documentation that you make and provide, including your draft DOC. We have successfully done this in both the above said scenario and offsite.
The ZLG document about OBL is a good lead. NB's who have performed OBL CE have also drafted their own guidelines for clients help.
If you wish to, ask UL (no affiliations) in your region.
 
Last edited:

Chrisx

Involved In Discussions
#7
I would recommend using a notified body from the UK. The MHRA guidance bulletin 19 for OBL is much less extensive and less complicated then the German EK-Med guidance.
 
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