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Some Related Topic Tags (Not all threads are Tagged)
notified body, ce mark and ce marking
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  Post Number #9  
Old 17th July 2016, 12:37 PM
ca_moni

 
 
Total Posts: 11
Re: Notified Body Number Size in CE Mark

Sorry to re-surface an old post but in our recent audit (EN ISO 13485+MDD), it was pointed out that the notified body number accompanying the CE mark "must be placed on the same baseline than the CE mark itself". I wasn't aware of such a requirement, and all our labels place the number vertically centered in respect to the CE symbol. the observation was given a sa sugegstion and no nonconformity or written finding was indicated in the report. I guess that, like there is no requirement for the number size, also positioning is not specified in any guidance. Am I right? someone has information on the contrary? how is your CE mark drawn? Thank you all

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  Post Number #10  
Old 17th July 2016, 07:25 PM
Ronen E

 
 
Total Posts: 3,186
Re: Notified Body Number Size in CE Mark

Quote:
In Reply to Parent Post by ca_moni View Post

Sorry to re-surface an old post but in our recent audit (EN ISO 13485+MDD), it was pointed out that the notified body number accompanying the CE mark "must be placed on the same baseline than the CE mark itself". I wasn't aware of such a requirement, and all our labels place the number vertically centered in respect to the CE symbol. the observation was given a sa sugegstion and no nonconformity or written finding was indicated in the report. I guess that, like there is no requirement for the number size, also positioning is not specified in any guidance. Am I right? someone has information on the contrary? how is your CE mark drawn? Thank you all
I am not aware of any such requirement, nor such guidance qiuickly comes to mind. I guess it's just the auditor's preference.

In such cases you can simply ask: "where does it come from?". Anyway, since it's not a NC you can opt to disregard it.

Cheers,
Ronen.
Thanks to Ronen E for your informative Post and/or Attachment!
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  Post Number #11  
Old 18th July 2016, 12:47 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,203
Re: Notified Body Number Size in CE Mark

Quote:
In Reply to Parent Post by ca_moni View Post

Sorry to re-surface an old post but in our recent audit (EN ISO 13485+MDD), it was pointed out that the notified body number accompanying the CE mark "must be placed on the same baseline than the CE mark itself". I wasn't aware of such a requirement, and all our labels place the number vertically centered in respect to the CE symbol. the observation was given a sa sugegstion and no nonconformity or written finding was indicated in the report. I guess that, like there is no requirement for the number size, also positioning is not specified in any guidance. Am I right? someone has information on the contrary? how is your CE mark drawn? Thank you all
Hii.. Your NB must have given you earlier how the CE mark + NB number has to be put.
Do ask they if they have not provided.....

The four-digit NB number is intended to be the same boldness and font as the “CE” characters. Therefore, NBs have interpreted the requirement to specify numbers that are at least half the height of the “C” and “E”—or at least 2.5 mm. Each NB also provides instructions to legal manufacturers on how to present the CE characters with their four-digit NB number. Usually, there are a couple of different orientations that are allowed by the NB. For small products, it may not be possible to mark the device with a “C” and “E” that is at least 5 mm. Therefore, the directives waive this minimum dimension for small-scale devices. Most companies, however, will place a “C” and “E” on their labeling that is at least 5 mm in height, instead of marking parts with a “CE” that is illegible.

Resource:
http://medicaldeviceacademy.com/what...-ce-mark-mean/

http://robertpackard.wpengine.com/wp...g-Examples.jpg
Thanks to somashekar for your informative Post and/or Attachment!
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