Authorized Representative:
The person, either a natural or legal entity established within the Union, who has received and accepted a written mandate from a manufacturer established outside the Union to carry out certain tasks related to the obligations of the manufacturer under this Regulation on behalf of the manufacturer.

If the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market provided that the manufacturer has appointed a single Authorized Representative.

For the Duties of the European Representative, see MDR Article 11

Article 11, Paragraph 5:
In cases where the manufacturer is not established in the European Union market, the Authorized Representative shall, on the same legal basis as the manufacturer, jointly and severally, be legally liable for defective devices.

Current Situation for Turkey:

In the document published by the European Commission titled “ACTOR MODULE FAQs October v1.6,” the following statement is included:

Economic operators established in the EU 27, Iceland, Liechtenstein, Norway, Turkey, or Northern Ireland can create actor registration requests in EUDAMED.

Manufacturers established outside these countries can only register if their Authorized Representatives are located in the EU 27, Iceland, Liechtenstein, Norway, Turkey, or Northern Ireland.