Importer or not?

[Marc Benet Pozo]

Hello Everyone,

We are a medical device company based in Spain, and we have subcontracted the manufacturing of our medical device to a company located within the European Union, but such company has their manufacture facilities in China. Then, Considering that they are manufacturing the device in china, and when the device is manufactured, it is sent to their European facilities to be stored, and finally, when we receive a purchase order from a client (Distributor or end-customer), the subcontracted company will sent the device from their facilities. Is the subcontracted company also the importer of such medical device?

 

[Jakub Milcarski]

Since your company is the Legal Manufacturer of the product and you are based in Spain there is no Importer.

 

[CM QARA]

Hello Everyone,

We are a medical device company based in Spain, and we have subcontracted the manufacturing of our medical device to a company located within the European Union, but such company has their manufacture facilities in China. Then, Considering that they are manufacturing the device in china, and when the device is manufactured, it is sent to their European facilities to be stored, and finally, when we receive a purchase order from a client (Distributor or end-customer), the subcontracted company will sent the device from their facilities. Is the subcontracted company also the importer of such medical device?

I believe you are correct. The MDR defines the importer as: "any natural or legal person established in the EU that places a device from a third country on the EU market". Thus, the subcontracted company (entity which receives the product into the EU) serves as the role of the importer.

 

[IS1027]

I believe you are correct. The MDR defines the importer as: "any natural or legal person established in the EU that places a device from a third country on the EU market". Thus, the subcontracted company (entity which receives the product into the EU) serves as the role of the importer.

Yes, but what if Marc's company is the design owner and full responsible for the device (legal manufacturer)? Wouldn't that make the devices theirs, and not from the subcontractor/Chinese factory?

I am also confused about this same topic. I think it is viable to subcontract the manufacturing of a device to another company, even an extra-EU company, while still being the legal manufacturer -and not importer- of the device.

My main question would be what happens when the labeling + packaging is also done outside of Europe (like China), and the device has to enter EU while being a fully completed product. The European company would still be the design owner and everything; is this viable? Would it be more of a customs issue than an MDR issue? Would really appreciate if someone could chime in on this!

 

[CM QARA]

There's no question that the legal manufacturer is Marc's company - but there's legal transfer of ownership (refer to the EU blue guide) to the subcontractor/Chinese factory - to actually conduct the manufacturing. Marc's company still own the CE mark and are the LM albeit with the subcontracting of manufacturing outside EU. They have a contract in place.

The entity which brings the finished device into the EU is defined as the importer. The importer will be suitably resourced to conduct the obligations of the importer under MDR. The importer is obviously a separate role to the legal manufacturer.

I understand your situation, it's a very confusing topic - my advice would be to directly contact the regulator with your query so you can get their guidance on your specific situation