NB number in CE mark

evan_kim90

Involved In Discussions
Hi, everyone!

I require help it is possible to do it or not.
So, we currently changed our NB so we got new NB number for CE mark.
My question is
  1. Is it able to using just sticker to update NB number? (Simply, just print new NB number as a sticker and apply top of the current NB number.)
  2. Like attached photo, is it allow to do like that?
    NB number in CE mark
3. Lastly, does not NB number has to be always bottom and right side?

Thanks in advance!
 

AllTheThings

Involved In Discussions
What directive(s) are you attempting to comply with? The marking requirements vary by directive...
 

evan_kim90

Involved In Discussions
What directive(s) are you attempting to comply with? The marking requirements vary by directive...
Not 100% sure but our DOC declared,
Directive 93/42/EEC for Medical Devices, Directive 2014/53/EU*, Directive 2014/30/EU*, and
Directive 2011/65/EU.
 

Belinda Lin

Medical Device RA
In my opinion, it is not a good idea to paste an additional label on top of the current label. You need to confirm with your new NB whether this method is acceptable and may also need to confirm with your client whether they accept this kind of modified label.
As a normal procedure, when you change the NB, you should reach an agreement with the old and new NB regarding the transition period from the old label to the new label to deplete the product inventory. Just refer to Article 58 of MDR, as well as this guidance: NBOG’s Best Practice Guide 2006-1 Change of Notified Body.

Regarding the NB number, MDR stipulates that the CE marking shall be followed by the identification number of the notified body but does not mention the exact position. It is reasonable that the manufacturer always puts this number at the bottom or to the right of the "CE", and I don't think there will be any other more appropriate way to display it.
 

Harsh

Involved In Discussions
Not 100% sure but our DOC declared,
Directive 93/42/EEC for Medical Devices, Directive 2014/53/EU*, Directive 2014/30/EU*, and
Directive 2011/65/EU.
Hi Evan, Do note that Directive 93/45/EEC is no longer in force & got repealed by the latest Regulation EU 2017/745 known as Medical Device Regulation (MDR). So, it would be essential that your product meets the applicable requirements as per MDR.
 

Raisin picker

Quite Involved in Discussions
Well, yes. MDD 93/42/EEC is no longer in force since May 2021. However, certificates issued under MDD can still be valid under certain conditions. But for all details, you should definitely contact your new NB. This extended transition period left a few huge gaps in regulations that are covered in a different way by the differenty NBs (or their CAs).
 

ChrisM

Quite Involved in Discussions
When I worked in the medical device industry I was told that you must not stick one label over another; not sure if this was FDA-mandated or is also covered under ISO13485 but if not, it is certainly not a good idea to stick over another label. As has been mentioned already, you should have reached an agreement with your new NB over products that were already CE marked as to how the transition will take place
 

CharlieUK

Quite Involved in Discussions
Whilst examples aren't provided, the wording in the MDR says "Where applicable, the CE marking shall be followed by the identification number of the notified body"
And section 4.5.1.5 of The Blue Guide says "The CE marking must be followed by the identification number of the notified body"

i.e , the label should say CE 0297 and not with the number under the CE mark
 
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