MDR Importer/Distributor Definition Questions

#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

Holed-up in a Hotel in South Florida
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.).
 
#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

Holed-up in a Hotel in South Florida
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.
 
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