EU Representative needed for Turkey?

MedicalDevice

Involved In Discussions
#1
Hello,
Could someone tell me if Turkey needs a EAR? I was told that since Turkey is in customs union with EC, there is no need for EU REP.
Thank you in advance for your feedback.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Not sure what you imply by "Turkey needs a EAR".
Is the manufacturer based in Turkey?
Is the manufacturer based outside the EU and selling in Turkey but in no other EU Member State?

It's always better to provide a few lines of context when starting a new thread, thank you.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
The MDR speaks of manufacturers "not established in a Member State" as being required to have an EU AR. As far as I can tell from this page, Turkey is not a Member State of the EU and is currently not progressing quickly in that direction.
 

MedicalDevice

Involved In Discussions
#5
The MDR speaks of manufacturers "not established in a Member State" as being required to have an EU AR. As far as I can tell from this page, Turkey is not a Member State of the EU and is currently not progressing quickly in that direction.
Thank you Ronen.

I was in doubt about if Turkey needs an EAR, because despite not being a Member State of the EU, the country is still in the EU Customs union (screenshot below):
1573567214943.png
 
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