What is the criteria for "small-scale device" regarding CE marking?

Mark Meer

Trusted Information Resource
#1
The Medical Device Directive 93/42/EEC states:

"The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm.
This minimum dimension may be waived for small-scale devices."
(emphasis added)

Wondering if anyone knows if there is any criteria here for "small-scale"? ...or is the interpretation purely up to an NB?

We've got a small device with a small label. Technically, it is possible to have the CE mark be 5mm high, but it would mean decreasing the size of everything else on the label. (which would not only make the other information more difficult to read, but would also make the label look terrible, as the CE mark would be far more prominent than anything else...)
 
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somashekar

Staff member
Super Moderator
#2
The Medical Device Directive 93/42/EEC states:

"The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm.
This minimum dimension may be waived for small-scale devices."
(emphasis added)

Wondering if anyone knows if there is any criteria here for "small-scale"? ...or is the interpretation purely up to an NB?

We've got a small device with a small label. Technically, it is possible to have the CE mark be 5mm high, but it would mean decreasing the size of everything else on the label. (which would not only make the other information more difficult to read, but would also make the label look terrible, as the CE mark would be far more prominent than anything else...)
Its between you and your NB.
It can be well addressed in the Labeling section of your technical file, with due justification for CE mark size used., and provide copy of label to your NB along with the technical file for review and approval.
 

pkost

Trusted Information Resource
#3
You should review the information that you have on the label and carry out a risk assessment; questioning what the information is therefore and what safety/efficacy improvements it brings. This can be used as a justification for decreasing the size to the level you have
 
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