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Do NB's want the Declaration of Conformity with GMDN code?
UL - Underwriters Laboratories - Health Sciences
Do NB's want the Declaration of Conformity with GMDN code?
Do NB's want the Declaration of Conformity with GMDN code?
Do NB's want the Declaration of Conformity with GMDN code?
Do NB's want the Declaration of Conformity with GMDN code?
Do NB's want the Declaration of Conformity with GMDN code?
Do NB's want the Declaration of Conformity with GMDN code?
Do NB's want the Declaration of Conformity with GMDN code?
Do NB's want the Declaration of Conformity with GMDN code?
Do NB's want the Declaration of Conformity with GMDN code?
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declaration of conformity, gmdn (global medical device nomenclature), gmdn codes, notified body
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  Post Number #1  
Old 2nd March 2015, 03:19 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,344
Question Do NB's want the Declaration of Conformity with GMDN code?

Is it expected by the NB's that the current Declaration of Conformity (DoC) contain the GMDN code ... ?

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  Post Number #2  
Old 2nd March 2015, 05:05 AM
SteveK's Avatar
SteveK

 
 
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Lurker 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
Thank You to SteveK for your informative Post and/or Attachment!
  Post Number #3  
Old 2nd March 2015, 01:41 PM
MIREGMGR

 
 
Total Posts: 3,685
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.)
Thanks to MIREGMGR for your informative Post and/or Attachment!
  Post Number #4  
Old 2nd March 2015, 03:56 PM
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c.mitch

 
 
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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.
Thank You to c.mitch for your informative Post and/or Attachment!
  Post Number #5  
Old 8th April 2015, 06:36 AM
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wrodnigg

 
 
Total Posts: 254
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)
Thank You to wrodnigg for your informative Post and/or Attachment!
  Post Number #6  
Old 9th April 2015, 10:01 AM
J0anne

 
 
Total Posts: 439
Re: Do NB's want the Declaration of conformity with GMDN code...

No Somashekar, it is not expected from any of the NBs I work with either.

Thank You to J0anne for your informative Post and/or Attachment!
  Post Number #7  
Old 12th April 2015, 03:12 AM
vinay anturkar

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

What is GMDN code?
  Post Number #8  
Old 12th April 2015, 05:10 AM
J0anne

 
 
Total Posts: 439
Re: Do NB's want the Declaration of conformity with GMDN code...

Quote:
In Reply to Parent Post by vinay anturkar View Post

What is GMDN code?
Vinay - Global Medical Device Nomenclature
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