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Do NB's want the Declaration of Conformity with GMDN code?

QMS for Medical Device Companies
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S

SteveK

#2
#2
Re: Do NB's want the Declaration of conformity with GMDN code...

Not to my knowledge. However, I do reference GMDNs in the Product Dossier section of my Technical Files, even though I have never had a request from my NB to do so.

Steve
 
M

MIREGMGR

#3
#3
Re: Do NB's want the Declaration of conformity with GMDN code...

My Authorized Rep expects codes as part of our DoC.

Our NB apparently doesn't, though. (I say "apparently" because we already include codes, but our NB has never referenced them.)
 
C

c.mitch

Quite Involved in Discussions
#4
#4
Do NB's want the Declaration of conformity with GMDN code...

Some NB's request manufacturers to add the GMDN code to the DoC and to the technical file.
It's not mandatory: never seen it neither in directive or in recommendations or meddev.
But I've never argued with NB auditors about that. If they want it, just pay the GMDN fee and add your code. An happy auditor is worth a few bucks.
 
W

wrodnigg

#5
#5
Re: Do NB's want the Declaration of conformity with GMDN code...

No, I do not require GMDN in any context.

(and I would request a different auditor, if one would require me spending money on that)
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#9
#9
Re: Do NB's want the Declaration of conformity with GMDN code...

MIREGMGR said:
My Authorized Rep expects codes as part of our DoC.

Our NB apparently doesn't, though. (I say "apparently" because we already include codes, but our NB has never referenced them.)
Click to expand...
Your AR has no jurisdiction granted by regulation over the contents of your DoC. Did you grant them such powers via contract?
 
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