Notified Body Number Size in CE Mark

CABRAC · Jul 7, 2010

Hi,

Long time listener and first time caller. During a current audit by our notified body, we were told the notified body number on our class IIb device CE mark must be 5 mm. I had always believed the "CE" portion needed to be 5 mm, but the notified body number whether below or to the side usually appears smaller.

Does anyone have any guidance on the size of the notified body number on the CE mark?

Thank you!

MIREGMGR · Jul 7, 2010

CABRAC said:
During a current audit by our notified body, we were told the notified body number on our class IIb device CE mark must be 5 mm.

Neither Annex III of the Machinery Directive, nor Annex IV of the Personal Protective Equipment Directive, nor Annex XII of the MDD specifies a height or typeface size for the NB identifier.

If you're sure you correctly understood your NB's comment, you might ask them for a citation to what regulation or guideline they are referring to.

CABRAC · Jul 7, 2010

That is precisely what I have found. When I asked, the auditor cited the MDD Annex XII where it states:

"The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm."

We asked again. The auditor called his office and found some who agreed with his interpretation and some that agreed with our interpretation. In the end, since there was nothing stating explicitly one interpretation of the NB size requirements, he agreed to let our interpretation stand.

Thank you for your help!

machrk · Jul 7, 2010

Great to see how Elsmar Covers help each other out this way

my site has CE mark for Construction Products Directive and my interpretation was that the CE mark had to be at least 5mm

I had not seen anywhere requirements for the sized of the notified body number - only that it had to be there

we have certainly found labelling can be a challenge - getting our techs to have the minimum detail etc etc

our notified body was particular on us getting the details right - but they didn't go beyond what are the stated requirements

cheers
@KerrieAnne aka machrk

bio_subbu · Jul 9, 2010

The directives on medical devices or the Regulation 765/2008 on accreditation and market surveillance do not make provision for the size of the Notified Body's identification number. But it is clear that the identification number must be visible, legible and indelible.

S. Subramaniam

xcanals_tecno-med.es · Jul 25, 2010

Please consider the EN 980 harmonized standard "Symbols for use in the labelling of medical devices" which states:
"...
4.2.5 All symbols and accompanying information shall be legible when viewed under an illumination of 215 lx using normal vision, corrected if necessary, at a distance which takes into account the specifics and size of the individual medical device.
NOTE Colours and minimum dimensions are not specified in this standard.
..."
as this spec's are sometimes difficult to demonstrate is usal to simplify them as "minimum size of 5 mm"

Regards
Xavier

MIREGMGR · Jul 25, 2010

xcanals_tecno-med.es said:
Please consider the EN 980 harmonized standard "Symbols for use in the labelling of medical devices" which states:
"...
4.2.5 All symbols and accompanying information shall be legible when viewed under an illumination of 215 lx using normal vision, corrected if necessary, at a distance which takes into account the specifics and size of the individual medical device.
NOTE Colours and minimum dimensions are not specified in this standard.
..."
as this spec's are sometimes difficult to demonstrate is usal to simplify them as "minimum size of 5 mm"

In my work, I see a lot of labels from competitive products...generally disposables, for which the label customarily will be read at a distance of a meter or less, and most often while handheld in front of the user, i.e. 30 to 50 cm.

I don't think I've ever seen a medical device label in that context that had the NB number at a height greater than 2.5mm.

My company has several thousand products, and of course is regularly audited in regard to our CE certificate. Our labels mostly include the NB number at a height of roughly 2 mm. Our NB has never mentioned that as a concern.

Ronen E · Jul 26, 2010

MIREGMGR said:
In my work, I see a lot of labels from competitive products...generally disposables, for which the label customarily will be read at a distance of a meter or less, and most often while handheld in front of the user, i.e. 30 to 50 cm.

I don't think I've ever seen a medical device label in that context that had the NB number at a height greater than 2.5mm.

My company has several thousand products, and of course is regularly audited in regard to our CE certificate. Our labels mostly include the NB number at a height of roughly 2 mm. Our NB has never mentioned that as a concern.

Hi,

I have seen labelling with all kinds of size proportions between the CE symbol itself and the NB number, including ones in which the proportion was 1:1 (never seen one where the number was bigger than the symbol, though

)

Based on my humble NB audit experiens I agree with the guideline bio_subbu included "that the identification number must be visible, legible and indelible". Never had a NB pick on us when that was the case.

Cheers,
Ronen.

ca_moni · Jul 17, 2016

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

Ronen E · Jul 17, 2016

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

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.

Notified Body Number Size in CE Mark

CABRAC

MIREGMGR

CABRAC

machrk

bio_subbu

xcanals_tecno-med.es

Involved In Discussions

MIREGMGR

Ronen E

Problem Solver

ca_moni

Involved In Discussions

Ronen E

Problem Solver

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