Need of EU Representative Designation for Turkey?

htcoztrk

Involved In Discussions
#1
Hello to everyone,

We are medical device manufacturer based in Turkey and I was wondering if we are obligated to designated a EU-RPE (Authorised representative) within the MDR. I couldn't find a clear answer to this not in regulation itself or any guide.

I know the MDR defines AR as "any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf ..." but as per the decision made by EU-Turkey Customs Union Joint Committee, we are not obligated to designate EU-REP since 2009 within MDD. So I was wondering if this decision still valid or is it void once MDR comes into force?

Kind regards,
Hatice
 
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koulidis

Starting to get Involved
#2
There is no agreement yet with Turkey and Switzerland for the MDR. It might be in the future. As things stand you need an ECREP.
 

htcoztrk

Involved In Discussions
#3
There is no agreement yet with Turkey and Switzerland for the MDR. It might be in the future. As things stand you need an ECREP.
Thank you for your reply. Actually there has been an agreement for Turkey but not for Switzerland. So Turkey is not obligated to designate an EC-REP under MDR for sales in EU.
 
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