Announcement Regarding the Draft Communiqué on the European Database for Medical Devices

As is known, in our country, within the framework of compliance with European Union (EU) legislation regarding medical devices and in vitro diagnostic medical devices, the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation, which were prepared in parallel with EU Regulations (EU) 2017/745 and (EU) 2017/746, have been in effect since they were published in the Official Gazette No. 31499, dated 2/6/2021.

However, in accordance with the provisions of Regulations (EU) 2017/745 and (EU) 2017/746 regarding the European Database for Medical Devices (EUDAMED), the competent authorities, notified bodies, manufacturers, authorized representatives, importers, system or procedure pack manufacturers, and sponsors of clinical investigations and performance studies have been granted access to and usage of EUDAMED. The Commission Implementing Regulation (EU) 2021/2078, dated 26 November 2021, which sets out the rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council regarding the European Database for Medical Devices (EUDAMED), entered into force on 19/12/2021.

In this context, as part of compliance with EU legislation, a draft of the "Communiqué on the European Database for Medical Devices" has been prepared in parallel with the mentioned regulation. Comments on the draft and its annexes, which are provided in the announcement, should be submitted in MS-Word or copyable PDF format to the email address md.reg@titck.gov.tr, in accordance with the Regulation on the Procedure and Principles for the Preparation of Legislation, no later than the close of business on 25/10/2024.

This is an important notice to those concerned.