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MDR Importer/Distributor Definition Questions

C

cathysueb

#1
I have a question that I am hoping someone may be able to answer.

The first is the definition an "importer" as used in the MDR. It states: "importer" means any natural or legal person established within the Union that places a device from a third country on the Union Market: " My question is what is meant by a third country. If the manufacturer is located in the United States and sells to a Distributor in the EU, there is no third country - so does that mean you do not need to have an "importer" whose duties are defined by MDR or does the distributor also become the importer and assume those duties as well.

Thanking you in advance for any input you may provide.

Cathy
 
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Al Rosen

Staff member
Super Moderator
#2
A Third Country is generally understood as any country not in the EU, including nations outside the continent of Europe (e.g. Japan, the USA, Canada, etc.).
 
C

cathysueb

#3
A Third Country is generally understood as any country not in the EU, including nations outside the continent of Europe (e.g. Japan, the USA, Canada, etc.).
Thank you - that was how I was interpreting the definition also. Based on that, with a product going from US to a distributor in an EU country, one would not need an importer; nor I am thinking would the distributor need to take on any importer duties that may differ from distributor duties.

Again, thanks.
 

Al Rosen

Staff member
Super Moderator
#4
Thank you - that was how I was interpreting the definition also. Based on that, with a product going from US to a distributor in an EU country, one would not need an importer; nor I am thinking would the distributor need to take on any importer duties that may differ from distributor duties.

Again, thanks.
I think it's the other way around. You need an importer to bring the device into the EU. The importer may also be the distributor.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
nor I am thinking would the distributor need to take on any importer duties
Your thinking is incorrect. If the device is not made within the EU, the entity placing the device on the EU market (i.e. executing the first sale within the EU) is considered an importer and has to take on the prescribed duties.
 
#7
Hi everyone!
I have a similar question about this topic... My company sells directly to several distributors in different member states within the EU. It seems to us that when we sell the medical devices to those distributors who are based in the EU, it constitutes "placing a device from a third country on the Union Market". Therefore, we consider that we (Manufacturer) have an Authorized Rep and a few distributors in the EU, but we do not have an Importer.
In addition, I saw that a comment above stated that a Distributor who purchased directly from us and then sold to a doctor in the EU would be considered as the Importer. However, there is another comment above stated that Importer and Distributor could not be the same entity. I guess I am a little confused on whether an Importer is absolutely required, and whether our "Distributors" are actually considered "Importers".
Thank you for your help in answering my questions in advance!
 

UNIJP

Starting to get Involved
#8
Hi everyone!
I have a similar question about this topic... My company sells directly to several distributors in different member states within the EU. It seems to us that when we sell the medical devices to those distributors who are based in the EU, it constitutes "placing a device from a third country on the Union Market". Therefore, we consider that we (Manufacturer) have an Authorized Rep and a few distributors in the EU, but we do not have an Importer.
In addition, I saw that a comment above stated that a Distributor who purchased directly from us and then sold to a doctor in the EU would be considered as the Importer. However, there is another comment above stated that Importer and Distributor could not be the same entity. I guess I am a little confused on whether an Importer is absolutely required, and whether our "Distributors" are actually considered "Importers".
Thank you for your help in answering my questions in advance!
In this case, each distributor is deemed as an Importer.
As long as the CE marking device comes from outside Union, the Importer role must be played by someone.
On the other hand, it could be no distributor role in the supply chain.
Yes, the importer and distributor role could not be the same entity, because the entity would be just deemed as an importer.
 
#9
In this case, each distributor is deemed as an Importer.
As long as the CE marking device comes from outside Union, the Importer role must be played by someone.
On the other hand, it could be no distributor role in the supply chain.
Yes, the importer and distributor role could not be the same entity, because the entity would be just deemed as an importer.
Thank you so much UNIJP for the clear explanation! That totally makes sense.
 
#10
Hello,

I also have a similar question.
My company sells devices directly to doctors in their own offices in the EU (not hospitals). We have come to believe that the doctor is the end user of the device. The doctor does not further distribute the device. Is the doctor an importer? Does the doctor need to register in Eudamed as an importer?
Is defining an importer role required if we sell directly to end users?

Thank you.
 
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