CE Mark on Promotional Material (Brochure for our Medical Device)

K

Kary13

#1
We are working on the promotional brochure for our medical device and we want to state that the device is CE-marked. However, we are not sure if, for the brochure, the number and address of the notified body has to be attached to the CE logo.

THanks!!!
 
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Stijloor

Staff member
Super Moderator
#2
Re: CE mark on promotional material (brochure)

We are working on the promotional brochure for our medical device and we want to state that the device is CE-marked. However, we are not sure if, for the brochure, the number and address of the notified body has to be attached to the CE logo.

THanks!!!
Can anyone with CE Mark experience help?

Thank you very much.

Stijloor.
 
A

Alexisss

#3
Re: CE mark on promotional material (brochure)

Hi,

You may have to check the contract between your company and your notified body, may be in there it is stated whether they allow you to use the CE mark on promotional material or not.

Otherwise, you may ask for their written approval.

Keep in mind that:

a) you cannot place the CE mark on a product catalog for example, which contains non-Ce marked items. In such case -catalog of CE marked and non-CE marked products- you may inform the NB that you intend to place the CE mark only on pages related to CE marked products. By all means, you must not leave any space for anyone to think that a non-CE marked product is CE marked.

b) If you also print the 4-digit NB identification number, you are risking to have to destroy a lot of promotional material in case your notified body changes for whatever reason (you change NB, they cancel your certification, it is bought by another one and they change id number etc).

Good morning !
a
 
S

SteveK

#4
Re: CE mark on promotional material (brochure)

We are working on the promotional brochure for our medical device and we want to state that the device is CE-marked. However, we are not sure if, for the brochure, the number and address of the notified body has to be attached to the CE logo.

THanks!!!
Hi Kary13,

Alexisss is right about using the CE mark in the literature and issues about non-CE marked products being present as well. Also if you use the NB logo the same thing applies (check with their rules as indicated). Just had a level 3surveillance audit and this exact issue was raised by the auditor. We do not use the CE Mark on any promotional material, except where it appears on a picture of the particular product. However, it is not likely that you will change NB (usually a bit difficult – there are various posts about this around that I have seen), so where you do use the CE Mark (legitimately) you do add the 4 digit number (e.g. on Operating Instructions).:2cents:

Steve
 
A

Adele

#5
Re: CE mark on promotional material (brochure)

We have a policy of putting CE mark (with NB identification number) on any promotional material that has instructions for use - regardless of the Class of the product.

However, you could leave it off if you device is Class I.
 
K

Kary13

#6
I've contacted my notified body but did not get an answer yet... However, from your answers, I am guessing that the safest way to do it would be the CE with the nb number... That's what we'll plan for now and can re-ajust if the nb says otherwise...

Thanks so much for the help!!! :)
 
W

Watchwait

#7
Can anyone please confirm that Canada, as of this date, does NOT require that Class IIa or IIb medical devices be CE marked? I am familiar with CMDCAS requirements, as well as ISO 13485 confiormance, but I need to verify this specific CE mark related question asap.

Thanks!
 

RA Guy

Involved In Discussions
#8
Canada has nothing to do with the European Conformity (CE) mark.
Canada requires that class II, III & IV (under Canadian device classification regulations) are licenced for sale by its federal regulator (Health Canada).
There are other requirements (13485 CMDCAS certificate, establishment licence) that also apply depending on the class of device and the activities you are involved with (manufacturing, import, etc.).

Path to full regulations found here:
http://www.hc-sc.gc.ca/dhp-mps/md-im/legislation/index-eng.php
 
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