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CE marking colour for Medical Devices

#1
Hi all,

I have been looking through guidance but can't locate anything on what colour the CE mark can be on a medical device. There is no requirement in Annex XII of the MDD or Annex V of the MDR There is only requirements for dimensions and size.

For instance, if we were to have a darker packaging, could the CE mark on that packaging be white to increase contrast from the background.

Thanks for your help.
 
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#3
I have seen only CE marking in Black colour so far. If it is a dark surface where back ground colour will dominate "CE" I guess one can use a "CE" in black colour in a small box of white back ground.
 

CharlieUK

Quite Involved in Discussions
#4
The requirements on the "CE mark" are "horizontal legislation" across all CE marking Directives, though some make specific relations for size
Section 4.5.1.4 of he 'Blue Guide' on the implementation of EU product rules 2016 provides guidance and includes
The CE marking can take different forms (e.g. colour, solid/hollow) as long as it remains visible, legible and respects its proportions. It must also be indelible so that it cannot be removed under normal circumstances without leaving noticeable traces (for example some product standards provide for a rub test with water and petroleum spirits). Nevertheless, this does not mean that the CE marking must form an integral part of the product.
 
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