If market the ce comfirmity medical device(classIIa) in Turkey, should the manufacturer not in the EU nor Turkey show "European Authorized Representative" in package?
Re: CE Marking - Turkey & European Authorized Representative - Class IIa Medical Devi
Hi, all,
I got the answer!
According to the Statement of Turkey – EC Customs Union Joint Committee on the
implementation of Article 1 of Decision 1/2006, the designation of an authorised representative in Turkey or in the community is mandatory and that these are therefore aligned with the EC legisation for MDD directive.Pls find the detailed in below link: http://www.dtm.gov.tr/dtmadmin/upload/DTS/ABTeknikMevzuatUyumuDb/statement.pdf
Thanks for your attention!!
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