EUDAMED ACTOR ANNOUNCEMENT ABOUT REGISTRATION

EUDAMED ACTOR ANNOUNCEMENT ABOUT REGISTRATION

As is known, the Actor registration module EUDAMED (European Database on Medical Devices), developed by the European Commission, was made available on December 1, 2020. Again, the “EUDAMED User's Guide” has been published by the European Commission and the translation process of the relevant Guide has been carried out by our Institution. In this context, economic operators (Manufacturer, Authorized Representative, Importer, SIP Manufacturer) within the scope of the Medical Device Regulation published in the Official Gazette No. 31499 dated 02.06.2021 are required to register for the actor registration module at EUDAMED in accordance with the october guide.

In this minvalde, the relevant economic operators operating in our country are required to submit actor registration applications at EUDAMED and the applications made will be reviewed by our Institution.

The company contact information (address, e-mail, etc.) entered into EUDAMED while the relevant registration procedures are being performed by the economic operators.) and the information contained in the Product Tracking System (UTS) and the Core Resource Management System (QMS) must be compatible.

Note: 1. Entering Tax Number information in the VAT Number field,

2. No information is entered in the EORL Number field,

3. It is necessary to enter the Company Identifier Number information in the National trade register field.

It is announced to the relevant parties with importance.

Source: https://www.titck.gov.tr/duyuru/eudamed-aktor-kaydi-yapilmasi-hakkinda-duyuru-18102021113223