Control of Medical Device Marketing and Promotional Materials - EU regulation

Jnks_Meddev

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#11
Is there a verbiage somewhere (MDD or in MDR?) on the use of CE marks and requiring the Notified Body 4 digits afterward that could apply to promotional materials?

Also, I thought you can't have CE marked products marked in the same brochure as non-CE marked products. Can someone help me find the specific language on this?


Thanks!!
 

Jnks_Meddev

Involved In Discussions
#13
Thanks Rosen! I did some search on the forum and found the same question asked by someone else.
We cannot place the CE mark on a product catalog that contains non-CE marked products or items. If we have CE and non-CE marked product we can inform our notified body of our intent to place the CE mark products only on pages related to CE marked products. As you mentioned having a non-CE marked product on CE marked product page can be misleading.
 

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