Importer shell game - Using a third party logistics provider (3PL) in the EU

Chrisx

Involved In Discussions
#1
We are a US orthopedic manufacturer using a third party logistics provider (3PL) in the EU to warehouse inventory, ship to our distributors and process loaner inventory. The 3PL would appear to meet the definition of importer per the MDR. The 3PL is placing devices from a third country on the Union market. They would thru their normal business processes add shipping labels and shipping documents to the shipments that would have fulfilled the requirements to identify the importer as required by the MDR. The 3PL is now telling me they can't be the importer and I must identify a 3rd party as the importer. They recommended an importer service provider https://www.luctormedical.com/eu-mdr-importer/. This seems like I am just setting up a 2nd EU authorized representative, so that the true importer doesn't have to register in Eudamed. Is this really what the authors of the MDR envisaged. It seems we are just creating a shell game to hide the identity of importers. What is the point of the importer if they can use a 3rd party to register. Their are no requirements in the MDR for the manufacturer to enforce this with the importer. Is the manufacturer responsible for ensuring the importer (who ever that really is???) acts appropriately per the MDR? This all seems like a shell game to me in order to hide the identity of importers. I now wonder if our EU authorized representative would agree to also serve as the importer, since they seem to do the same thing.
 
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twanmul

Involved In Discussions
#2
I'd advise them that you aren't willing to register with a third party "importer" (this is how that company you'd linked to put it, but the Regulation implies that the importer takes physical receipt of the product. I think what the linked compy are doing is exploiting the letter of the regulation but isn't necessarily in keeping with the spirit) and that if your 3PL isn't willing to be the importer, you'll have to switch to an alternate distributor who is willing to act as the importer.
 

Chrisx

Involved In Discussions
#3
The 3PL confirmed that they are avoiding acting as the importer due to concerns over liability. It would seem to me that if a natural or legal person physically receives a product from a third country and further ships it to distributors, then they are by definition the importer. My main concern is that things like this have a way of trickling down hill. The competent authorities lack the resources to enforce the regulation, so they push it on the notified bodies. The notified bodies push it on the manufacturer to enforce the requirements on the importer. Maybe, I'm paranoid or don't understand the regulation correctly?
 

L_O_B

Involved In Discussions
#4
This is actually not that easy and similar questions come up a lot currently.

The technical terms are very important in that context.
The importer is the one placing a device from a third party on the Union market. As you all know, placing on the market is the first making available on the market of a unit.

Considering:
"The making available of a product supposes an offer or an agreement (written or verbal) between two or more legal or natural persons for the transfer of ownership, possession or any other right concerning the product in question after the stage of manufacture has taken place. The transfer does not necessarily require the physical handover of the product." (Blue Guide)

Now, does the 3PL offer the devices to the distributors, or are you offering the device and 3PL is just handling the logistics on your behalf? In that case, 3PL is a fulfilment service provider (see regulation (EU) 2019/1020). However, if 3PL offers the devices in their own name, they are the importer of the device. Fulfilment service providers do not have defined requirements in the MDR.

There is no regulatory requirement for you to control your importer(s). Although, it is in your interest that your importer (and also your distributors) complies with regulatory requirements, because non-compliances could affect the market access for your devices. Keeping this in mind and also considering that the requirements for importers are stricter that for distributors, it makes sense to only have one importer for your devices in Europe. Nevertheless, I can also understand that the 3PL is not interested in acting as an importer and assuming the services they offer, they probably do not fall under the definition. In this scenario, all distributors receiving devices from the 3PL would become importers and would have to comply with the importer requirements accordingly.
 
#5
Importers have to be very careful as they have a lot of legal obligations and liabilities under MDR, and they are required to register for EUDAMED to verify the data for the products they are responsible for. We have produced templates to help with the legal obligations of all the Economic operators.
 
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Nigel-S

Starting to get Involved
#6
I have a very similar situation. Shipping from Canada to a 3PL in the Netherlands. We have our own VAT # being registered in the Netherlands so that we can act as our own importer as we have for a long time now. However the MDR seems to indicate that we will not be able to continue to be our own importer - (there is a separate post on my issue and not wishing to hijack this post).
Chrisx, did you get any further with your 3PL/importer issue?
Cheers, Nigel
 
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