C
cathysueb
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
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