The Turkish version of the “Guide to Using EUDAMED - Actor Registration Module" (“Guidance”) has been published with the Turkish Medicine and Medical Devices Agency’s (“TITCK”) announcement dated 18 October 2021.
Background of the European Database on Medical Devices
Pursuant to Article 33 of the Regulation (EU) 2017/745, and Article 30 of the Regulation (EU) 2017/746 which mandated the establishment of a European database on medical devices, the European Database on Medical Devices (“EUDAMED”) was developed by the European Commission (“Commission”).
EUDAMED aims to ensure the transparency and coordination of information regarding medical devices on the EU market. In this direction, as a multipurpose system, the new version of EUDAMED will be interoperable and will act as a registration system, a collaboration system, a notification system, and it will also be open to the public.
EUDAMED has been established for the following purposes:
- To enable the public to be adequately informed about the devices supplied to the market, the relevant certificates issued by the notified bodies, and the relevant economic operators,
- To enable singular identification of devices in the market and to facilitate their traceability,
- To enable the public to be adequately informed about clinical trials and to enable sponsors of clinical trials to comply with their obligations,
- To enable manufacturers to comply with obligations regarding reporting and vigilance analysis,
- To enable the competent authorities to conduct their duties and to strengthen cooperation among them.
To fulfil those purposes, as well as a public website, there are six interconnected modules in the new version of EUDAMED:
- Actor registration,
- UDI/Device registration,
- Notified bodies and certificates,
- Clinical investigations and performance studies,
- Vigilance and post-market surveillance, and
- Market surveillance
The first of six planned modules for EUDAMED, the Actor registration module, became available to EU Member States and economic operators as of 1 December 2020. The Guidance was published on 6 November 2020 by the Commission to assist stakeholders in understanding various harmonized processes and technical solutions prior to EUDAMED becoming fully functional.
Impacts of EUDAMED on the Turkish Medical Device Industry
Turkey introduced the updated "Medical Device Regulation", and the "In vitro Diagnostic Medical Device Regulation" on 2 June 2021, in accordance with the new EU medical device regulations, which were updated in the EU to comply with current technology and living standards.
In this direction, the new EUDAMED system has been integrated into Article 33 of the Medical Device Regulation and Article 31 of the In vitro Diagnostic Medical Device Regulation with the aim of both enhancing transparency in the Turkish medical device industry and fully harmonizing with the updated EU regulations.
Following the inclusion of the new EUDAMED system in Turkish medical device industry practice, economic operators, manufacturers, authorized representatives, and importers (collectively referred to as “economic operators”) in Turkey are also required to register with the EUDAMED database. Therefore, all medical devices must be registered to EUDAMED prior to placing them on the market, with the exception of on-demand devices.
All parties are required to ensure full adherence to this new system. Since records will be open to the public they must always be kept in a clear and understandable language. Moreover, the data should be provided in an organized and accessible format.
What Does the TITCK Announcement Bring?
The TITCK Department of Medical Device Registration and Coordination announced on 18 October 2021 that the Guidance has been translated into Turkish, and in this context, economic operators are obliged to register with the EUDAMED Actor registration module in line with the Guidance.
TITCK will review EUDAMED actor registration applications.
In addition, company contact information (address, e-mail, etc.) submitted to EUDAMED during the registration process must be compatible with the information in the Product Tracking System (“UTS”) and Core Resource Management System.
And lastly, following the first announcement dated 18 October 2021, TITCK added further notes stating the requirement to:
- enter a tax number to the VAT Number area,
- not enter any information to the EORL Number area,
- enter the company identification number to the National Trade Register area.
How Does the Actor Registration Module Work?
The Actor registration module allows economic operators to provide the information required to receive a single registration number ("SRN"), which ensures a unique identity for them throughout the EU.
Following the assessment and approval of the submission by TITCK, EUDAMED generates an SRN for the related economic operator and transfers it to the competent authority. An SRN is issued to the applicant Actor once the information input into the system is validated by TITCK which is a competent and responsible authority for assigning a new SRN in Turkey. It should be noted that economic operators must obtain a separate SRN for each Actor role it performs.
There Is Still Time for Medical Device Companies
It should be noted that registration with the Actor module does not imply that data entry into EUDAMED has begun. However, medical device companies’ UTS obligations and other important responsibilities, in particular vigilance reporting, clinical investigations, and device registration regulated under the former regulation will still be in force until EUDAMED is fully functional.
According to Article 111 of the Medical Device Regulation titled “Effectiveness”, Article 33/3 of the Medical Device Regulation and the obligation to start data entry will enter into force six months after the publication of a notification that EUDAMED is fully functional and meets its functional specifications by the Commission in the Official Journal of the EU.
Regarding the current situation on the phases of modules, the Commission has announced that development activities are in progress. In that vein, except for the mechanism for scrutiny and the clinical evaluation consultation procedure (“CECP”), the second module on UDI/device registration and the third module on notified bodies and certificates have been accessible since October 2021. When EUDAMED is completely functioning, the other modules, as well as the scrutiny mechanism and the CECP, will be released.
Following its introduction by the Commission on 6 December 2020, the Turkish version of the Guidance is now also available for economic operators in the Turkish medical device industry that are required to make applications in accordance with it.
However, economic operators and their representatives should closely follow the various procedures outlined in the Guidance and other upcoming modules to ensure compliance with the requirements prior to EUDAMED being fully functional.
Finally, as a positive note, before EUDAMED becomes fully operational, economic operators may take advantage of the phased introduction procedure by becoming familiar with the Guidance and other upcoming modules.
Kemal Altuğ Özgün