Importer of record - Europe

Nigel-S

Starting to get Involved
#1
We are a Canadian manufacturing company currently shipping product into Europe. We are our own IOR and have a VAT # registered in the UK. Due to Brexit we have applied for a VAT # in the Netherlands. We are going through the CE mark process for a Class I product and are receiving push back that we cannot be the IOR under the MDR due to conflict of interest. We ship our product to a 3PL in the Netherlands but they do not want to act as an importer for us.
We have complied with the customs requirements, CE declaration, labelling, UDI-DI, Post Market Surveillance for complaints, IOR details on packaging etc.
What are your opinions as to why could we not continue to act as our own IOR under the MDR ?
 
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