CE marking for NON-EU

MedicalDevice

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Hi everyone! I hope you are all well and healthy!
I have a question regarding the CE marking. if I am the EAR of a non-EU organization that wants to market their products in Europe, how will that organization affix the CE mark on their products? Do they need to submit an application to the competent authority of our country (since we are their EU REP)?
 
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