Notified Body Number with CE Mark

HnZul

Starting to get Involved
#1
Greetings!
It is our first time to explore Europe market for medical device. Could anyone help me to clarify below matter?
1. As far as I understand, we only can fix the CE mark on labelling once granted from NB. Does this means all our sample for validation and testing is without the CE mark. Only after NB assess and granted the CE, we can fix them on the labelling? Seems like we need to actually purchase twice for the labelling and packaging stuff. Or actually if we decided to go for e.g. TUV SUD then we can fix the CE mark and NB number on labelling and get them assessed by NB?

2. We have primary packaging (single unit pack) and secondary packaging (50 unit pack). Since we haven't engaged with any consultants or EAR (which mean we don't officially have the EC Rep information to fix on labelling). Can we just fix EC rep information on the secondary packaging?

Thank you in advance!
 
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Benjamin Weber

Trusted Information Resource
#2
The involvement of a notified body depends on the risk classification of your device. You need an NB if the class is other than "I" - "Is", "Im", "IIa", "IIb", "III" need a NB.

For verification purpose is is allowed to have the number on the markings, as long as you don't put devices onto the market before you have the final certificate of the NB.
 

HnZul

Starting to get Involved
#3
Yes thank you Benjamin.
Ours is class IIa which require NB involvement for conformity assessment. Thank you for answering question 1. What about question 2? Do you have any idea?
 

mboynton

Starting to get Involved
#4
On #2, the regulation states that the EC Rep information should appear on the label (see Annex I, 23.2(d)).

The default understanding would be that means the EC Rep information should appear on the single unit pack.

However, consider how Annex I, 23.1(b) may apply to your situation - "The information required on the label shall be provided on the device itself. If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit, and/or on the packaging of multiple devices."

If the label for the single unit pack is inherently space constrained because of the size of your device, then it may be plausible to argue that it is not practicable for the EC Rep information to appear on the single unit pack. If you are going to consider that approach, then you should make sure that there is no other non-required information taking up space on the single unit pack label - otherwise, the NB would likely object to the "not practicable" argument about the EC Rep info.
 

mboynton

Starting to get Involved
#5
On a related subject, if you've not already considered how your EU Importer information will appear with your device, I'd suggest you include that as part of your EU labeling plan, too. See the regulation Article 13(3).
 
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