EUDAMED ACTOR AND DEVICE REGISTRATION


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EUDAMED ACTOR AND DEVICE REGISTRATION

ABOUT EUDAMED

EUDAMED is the IT system developed by the European Commission to implement EU medical device regulations:

• Regulation (EU) No 2017/745 on medical devices

• Regulation (EU) 2017/746 on in vitro diagnostic medical devices


EUDAMED will be structured around 6 interconnected modules and a public site:

• User registration and management with Actor

• UDI database and device registration

• Certificates and Notified bodies

• Clinical research and performance studies

• Vigilance and post-market surveillance and inspection

• Market surveillance and inspection


Turkish Medicines and Medical Devices Agency (TİTCK) // ANNOUNCEMENT ABOUT EUDAMED ACTOR REGISTRATION

It has been reported that there is an “Announcement on EUDAMED Actor Registration” published by the Department of Medical Device Registration and Coordination on the website of the Turkish Medicines and Medical Devices Agency (TİTCK).


With the announcement, it is stated that the EUDAMED (European Database on Medical Devices), Actor registration module was made available by the European Commission on 1 December 2020. Again, "EUDAMED User's Guide" was published by the European Commission and the related Guide was translated by TITCK. In this context, it is stated that economic operators (Manufacturer, Authorized Representative, Importer, SIP Manufacturer) within the scope of the Medical Device Regulation published in the Official Gazette dated 02.06.2021.


In this respect, it is reported that the relevant economic operators operating in our country should apply for actor registration at EUDAMED and that the applications will be examined by TITCK.


It is stated that the company contact information (address, e-mail, etc.) entered in EUDAMED while the relevant registration procedures are carried out by the economic operators and the information in the Product Tracking System (ÜTS) and Core Resource Management System (ÇKYS) must be compatible.


WHO SHOULD REGISTER ACTOR WITH EUDAMED?

1. Manufacturers

2. Importers

3. Authorized representatives

4. System/Procedure package manufacturer


WHO SHOULD REGISTER A DEVICE WITH EUDAMED?

Only manufacturers should register devices with Eudamed after actor registration is complete.


Medical Device Registration Module

The new MDR 2017 745 and IVDR 2017 746 regulations introduce an identification system for medical devices based on a Unique Device Identifier and require medical device manufacturers to record UDI Device information of all devices they release.

Please contact us for your EUDAMED actor and device registrations.