Importer and Registered Place of Business in EU

[snoopy2017]

Hello,

A foreign manufacturer would like to get into EU. I understand that an authorized representative may not be an importer. It's just an agent to help you comply with EU directives and obtain the CE mark. If this company has an EU-based sales office, is this sales office considered an importer? This sales office is registered place of business. Could somebody help answer this question? This EU-based office is just a sales arm of this company, who receives the products from the foreign manufacturer. On the EU label, it is the AR's name and address, not the importer. Under EU's new MDR, we need to know the roles of all economic operators. Could somebody please clarify? Who is the importer?

Thank you.

 

[Ronen E]

Hello snoopy2017 and welcome to the Cove

First thing first.

In the EU, where an AR is necessary, the AR and the importer can be either the same or different.

Where a foreign manufacturer has a registered place of business in the EU (can be just a sales office or otherwise), an AR is not required.

The importer is whoever gets first hold of the devices, physically, inside the EU. If the sales office gets actual custody of the devices when they enter the EU (eg they have an EU warehouse), they are the importer.

In the case you describe the device label doesn't need to show an AR. Instead, it should show the registered address of the EU-based sales office, as well as the address of the manufacturer's overseas HQ.

The new MDR was not yet officially passed in the EU parliament.

Cheers,
Ronen.