European (CE) Device Label Requirements - Visibility

S

SmallD

#1
Our device labels (stickers), up to now, have not been problematic. Now we have a device that management and marketing do not want a label and especially our standard label, because of aesthetics.
My questions are:
1) Outside of the obvious sources for the need of the label (60601-1, 60601-1-11, ISO 1041, etc.), where is it clearly written the need for a device label? (I need more ammunition for an upcoming meeting)

2) Can the label be transparent, under the condition that the content is clearly visible?

3) Is it permissable to split the label?

The label (sticker) will not be for FDA scrutiny (for EU market, CE) so symbols will be used as much as possible.

Thanks :(
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Our device labels (stickers), up to now, have not been problematic. Now we have a device that management and marketing do not want a label and especially our standard label, because of aesthetics.
My questions are:
1) Outside of the obvious sources for the need of the label (60601-1, 60601-1-11, ISO 1041, etc.), where is it clearly written the need for a device label? (I need more ammunition for an upcoming meeting)

2) Can the label be transparent, under the condition that the content is clearly visible?

3) Is it permissable to split the label?

The label (sticker) will not be for FDA scrutiny (for EU market, CE) so symbols will be used as much as possible.

Thanks :(
Hi,

1) Refer to the MDD's essential requirements (annex I) and especially ER #13, for the regulatory basis of labelling requirements.

2+3) I am not aware of such specific limitations, as long as all applicable labelling requirements are met.

Cheers,
Ronen.

PS If the device is too small or it's otherwise impractical to label it (not just "not desired") then you may be able to get away with labelling the immediate packaging instead.
 
B

Burgmeister

#3
As stated by Ronen, check the requirements of the MDD.

ISO 980 ( a useful standard for symbols) makes the statement that no colour or size is stated as a requirement. However it does give guidelines on how readable it should be (under what lux and from what distance etc).

Not sure what you mean by splitting the label. If you mean can you put some information on a label on the front of the box and some on the back, then yes, the label can be split as long as it all makes sense and it is all there.
 
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