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Ilan Goldberg
Sr. QA/RA Expert at Physio-logic Ltd.
November 2017
Indicating CE Marking on product’ catalogue
< 1 min reading time

Our product received CE certification. In addition to the product labels and IFU, We would like to indicate in our product’ catalogue the CE Marking with N.B number. Is it allowed? Please explain/Make citation.
Thank you.

source: https://www.linkedin.com/groups/2070960/2070960-6341280311501955073

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Posted by Ilan Goldberg
Asked on November 28, 2017 8:00 am
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Private answer
Marcus Gould Yes, Article 17 of the MDD, Article 16 of the IVD Directive. 'Sales' packaging for both includes catalogue. However, contact your NB to get clarification
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Private answer
Hyemi Shin (신혜미,차장) You need to check the contract with your notified body, there may be stated whether they allow you to use the CE mark on promotional material or not. This was CE ISO auditor's comment from previous conpany. If not mentioned in contract, you may ask to NB whether there is documented requirement or not fot CE marking on brochure.
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Private answer
Eyal Lerner, Ph.D., B.Pharm, ICQE Dear Illan,

According to blue guide (OJ (2016/C 272/01) ): "Where should the CE marking be affixed? The marking shall be affixed either to the product or to the product's data plate. When that is not possible due to the nature of the product, the CE marking shall be affixed to the packaging and/or to any accompanying documents."
I guess "...accompanying documents" could correspond with the mentioned document by you.
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G M Butcher The rules for marking are available from your NB, they probably already gave them to you in the received paperwork.
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Ronald Boumans Hi Ilan, The Directive requires the CE-mark being present on the label and in the IFU. It does not say anything about it anywhere else. Therefore you can presume it is allowed to publish it in marketing material, including advertisements. Of course you can't claim a CE-mark that is not there, so be aware of your promotional materials in case of suspension or withdrawal of a certificate.
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Barry Fitch The CE Mark and NB number are specific to a device or family of devices. It would apply to those devices that have been assessed by the NB. If it was a product leaflet then yes but if you brochure includes devices that have no NB oversight then I would suggest no
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