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Notified Body Number Size in CE Mark


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notified body, ce mark and ce marking
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  Post Number #1  
Old 7th July 2010, 11:45 AM
CABRAC

 
 
Total Posts: 8
Please Help! Notified Body Number Size in CE Mark

Hi,

Long time listener and first time caller. During a current audit by our notified body, we were told the notified body number on our class IIb device CE mark must be 5 mm. I had always believed the "CE" portion needed to be 5 mm, but the notified body number whether below or to the side usually appears smaller.

Does anyone have any guidance on the size of the notified body number on the CE mark?

Thank you!

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  Post Number #2  
Old 7th July 2010, 12:39 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: Notified Body Number Size in CE Mark

Quote:
In Reply to Parent Post by CABRAC View Post

During a current audit by our notified body, we were told the notified body number on our class IIb device CE mark must be 5 mm.
Neither Annex III of the Machinery Directive, nor Annex IV of the Personal Protective Equipment Directive, nor Annex XII of the MDD specifies a height or typeface size for the NB identifier.

If you're sure you correctly understood your NB's comment, you might ask them for a citation to what regulation or guideline they are referring to.
Thanks to MIREGMGR for your informative Post and/or Attachment!
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  Post Number #3  
Old 7th July 2010, 01:26 PM
CABRAC

 
 
Total Posts: 8
Re: Notified Body Number Size in CE Mark

That is precisely what I have found. When I asked, the auditor cited the MDD Annex XII where it states:

"The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm."

We asked again. The auditor called his office and found some who agreed with his interpretation and some that agreed with our interpretation. In the end, since there was nothing stating explicitly one interpretation of the NB size requirements, he agreed to let our interpretation stand.

Thank you for your help!
Thank You to CABRAC for your informative Post and/or Attachment!
  Post Number #4  
Old 7th July 2010, 08:07 PM
machrk's Avatar
machrk

 
 
Total Posts: 102
Thumbs up Re: Notified Body Number Size in CE Mark

Great to see how Elsmar Covers help each other out this way

my site has CE mark for Construction Products Directive and my interpretation was that the CE mark had to be at least 5mm

I had not seen anywhere requirements for the sized of the notified body number - only that it had to be there

we have certainly found labelling can be a challenge - getting our techs to have the minimum detail etc etc

our notified body was particular on us getting the details right - but they didn't go beyond what are the stated requirements

cheers
@KerrieAnne aka machrk
  Post Number #5  
Old 9th July 2010, 08:13 AM
bio_subbu's Avatar
bio_subbu

 
 
Total Posts: 616
Re: Notified Body Number Size in CE Mark

The directives on medical devices or the Regulation 765/2008 on accreditation and market surveillance do not make provision for the size of the Notified Body's identification number. But it is clear that the identification number must be visible, legible and indelible.

S. Subramaniam
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  Post Number #6  
Old 25th July 2010, 08:51 AM
xcanals_tecno-med.es's Avatar
xcanals_tecno-med.es

 
 
Total Posts: 83
Re: Notified Body Number Size in CE Mark

Please consider the EN 980 harmonized standard "Symbols for use in the labelling of medical devices" which states:
"...
4.2.5 All symbols and accompanying information shall be legible when viewed under an illumination of 215 lx using normal vision, corrected if necessary, at a distance which takes into account the specifics and size of the individual medical device.
NOTE Colours and minimum dimensions are not specified in this standard.
..."
as this spec's are sometimes difficult to demonstrate is usal to simplify them as "minimum size of 5 mm"

Regards
Xavier
Thank You to xcanals_tecno-med.es for your informative Post and/or Attachment!
  Post Number #7  
Old 25th July 2010, 09:07 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: Notified Body Number Size in CE Mark

Quote:
In Reply to Parent Post by xcanals_tecno-med.es View Post

Please consider the EN 980 harmonized standard "Symbols for use in the labelling of medical devices" which states:
"...
4.2.5 All symbols and accompanying information shall be legible when viewed under an illumination of 215 lx using normal vision, corrected if necessary, at a distance which takes into account the specifics and size of the individual medical device.
NOTE Colours and minimum dimensions are not specified in this standard.
..."
as this spec's are sometimes difficult to demonstrate is usal to simplify them as "minimum size of 5 mm"
In my work, I see a lot of labels from competitive products...generally disposables, for which the label customarily will be read at a distance of a meter or less, and most often while handheld in front of the user, i.e. 30 to 50 cm.

I don't think I've ever seen a medical device label in that context that had the NB number at a height greater than 2.5mm.

My company has several thousand products, and of course is regularly audited in regard to our CE certificate. Our labels mostly include the NB number at a height of roughly 2 mm. Our NB has never mentioned that as a concern.
Thanks to MIREGMGR for your informative Post and/or Attachment!
  Post Number #8  
Old 26th July 2010, 03:22 AM
Ronen E

 
 
Total Posts: 3,091
Re: Notified Body Number Size in CE Mark

Quote:
In Reply to Parent Post by MIREGMGR View Post

In my work, I see a lot of labels from competitive products...generally disposables, for which the label customarily will be read at a distance of a meter or less, and most often while handheld in front of the user, i.e. 30 to 50 cm.

I don't think I've ever seen a medical device label in that context that had the NB number at a height greater than 2.5mm.

My company has several thousand products, and of course is regularly audited in regard to our CE certificate. Our labels mostly include the NB number at a height of roughly 2 mm. Our NB has never mentioned that as a concern.
Hi,

I have seen labelling with all kinds of size proportions between the CE symbol itself and the NB number, including ones in which the proportion was 1:1 (never seen one where the number was bigger than the symbol, though )

Based on my humble NB audit experiens I agree with the guideline bio_subbu included "that the identification number must be visible, legible and indelible". Never had a NB pick on us when that was the case.

Cheers,
Ronen.
Thanks to Ronen E for your informative Post and/or Attachment!
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