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Notified Body Number Size in CE Mark

somashekar

somashekar

Staff member
Super Moderator
#11
#11
ca_moni said:
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
Click to expand...
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-does-the-ce-mark-mean/

http://robertpackard.wpengine.com/wp-content/uploads/CE-Marking-Examples.jpg
 
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