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Multiple importers

koulidis

Starting to get Involved
#1
A manufacturer outside EU produces a single medical device. He has designated an ECREP. How many importers can he have? According to the definition of the MDR an importer is the one who places first the product on the EU market. Is this per EU country or for all EU countries?

For example if a company places the product first on the market of Germany and then another company places the product first in the market of Italy, are these 2 companies considered importers? Or importer is considered only the one that placed the product on Germany (fisrt placement in EU)?
 
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Cybel

Involved In Discussions
#2
Hi,
I don't have an answer for sure, but take a look to the definitions:
MDR, definition (33):
‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;

Blue Guide, par. 2.3
"the concept of placing on the market refers to each individual product, not to a type of product, and whether it was manufactured as an individual unit or in series"

So, I think to understand that the qualification of importer refers to each individual product, not to a model or LOT or the "first EU country", so in your example both the Italian and German entities are importers because both place on the market an individual product for the first time.
 

Awadine

Starting to get Involved
#3
Hi

i would agree. There can be multiple importers. It all depends on who is purchasing from whom. All EU entities purchasing direct from a non EU manufacturer and then placing on the EU market are likely to be importers. If an EU entity is purchasing a product from another EU entity they will likely be a distributor not an importer.

Coordinating all EU sales through the EU REP would help simplify so the EU REP is also the single EU importer.
 
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