European Authorised Representative (EAR) for manufacturers based in Turkey

European Authorised Representative (EAR) for manufacturers based in Turkey

The Customs Agreement between the European Union and Turkey, or Ankara Agreement, facilitates the trade of medical devices between the Member States and Turkey. Under the Medical Devices Regulation and the IVD Medical Devices Regulation, and under the Directives, non-EU manufacturers must designate a European Authorised Representative (EAR) to sell their products on the EU market. For Turkish manufacturers, this obligation does not apply.


The principles of the Customs Agreement

In a note to stakeholders published in March 2022, the European Commission specifies that:

“Manufacturers established in the EU have no obligation to designate an authorised representative in Turkey in order to place devices on the Turkish market. Vice versa, manufacturers established in Turkey have no obligation to designate an authorised representative on the EU territory in order to place medical devices on the EU market.”

The direct implication of the Customs Agreement on manufacturers from Turkey is the removal of the possibility to appoint an EAR (as it was possible under the Medical Directives legal framework). This means, a company based in the European Union can no longer represent manufacturers of medical devices and IVD medical devices located in Turkey.


Turkish manufacturer may appoint an EAR in reference to legacy devices

Considering the above and in line with the general acceptance of Competent Authorities in Europe to accept the designation of an EAR for Turkish manufacturers under the Medical Devices Directive (MDD) and the IVD Medical Devices Directive (IVDD), Turkish manufacturers fulfilling legacy requirements may continue to appoint an EAR in the EU and request a Free Sales Certificate from the relevant EU Competent Authority


Turkish manufacturers sales on the Swiss and UK markets

Because of Brexit and the absence of MRA both UK and Switzerland are considered ‘’third countries’’ for the EU. Consequently, Turkish manufacturers who want to sell in these two areas must appoint an Authorised Representative in the country of sales, namely “Responsible Person” in the UK and ‘’Swiss Authorised Representative (CH-REP)’’ in Switzerland.

Obelis supports worldwide manufacturers who want to sell in Switzerland or the United Kingdom with many services. Among others, Obelis acts as your Swiss Authorised Representative and UK Responsible Person. Obelis services for Turkish manufacturers on the EU market

Whether based in the European Union or not Obelis offers numerous services for manufacturers of medical devices. Among others, Obelis will keep offering EAR services for Turkish manufacturers who are subject to legacy requirements.

With consultancy agreements, Obelis will continue to support manufacturers to be compliant with the applicable legislation, keep them up to date with the most recent regulatory changes and offer technical, regulatory and consultancy services to uphold the European regulatory requirements.


Are you a Turkish manufacturer? Would you like to expand your sales in the EU, United Kingdom, and Switzerland?

Contact us today!

Get in touch

Simona Varrella

Publications Department

13.10.2022


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