Authorized Representative: A natural or legal person resident in the Union who receives and accepts a written power of attorney from a manufacturer located outside the Union, to perform certain tasks on behalf of the manufacturer related to the manufacturer’s obligations under this Regulation.
Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.
For Assignments of Authorised Representative See. MDR Article 11
Article 11, Clause 5; Without where the manufacturer is not established in a Member State and has not complied with the obligations laid down the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
Latest Situation for Turkey;
The following statements are included in the «ACTOR MODULE FAQs October v1.6» document published by the European Commission;
Economic operators based in EU 27, Iceland, Liechtenstein, Norway, Turkey or Northern Ireland can create actor registration requests at EUDAMED.
Manufacturers located outside these countries will only be able to register if their Authorized Representative is based in EU 27, Iceland, Liechtenstein, Norway, Turkey or Northern Ireland.