The Turkish Pharmaceuticals and Medical Devices Authority (TİTCK) recently announced that the Medical Device Clinical Trials Regulation (“Draft Regulation“) is open for public consultation. The Draft Regulation introduces certain amendments to ensure the medical device clinical trial process’s compliance with the Medical Device Regulation.
What are the Amendments to the Draft Regulation?
On its announcement dated 9 February 2022, the TİTCK opened the Draft Regulation to public consultation. The Draft Regulation sets forth the procedures and principles regarding medical device clinical trials, the rights of volunteers participating in these trials and post-marketing studies. The Draft Regulation aims to update the current Medical Device Clinical Trials Regulation in accordance with the Medical Device Regulation. The Draft Regulation is available online here (in Turkish).
The main amendments introduced in the Draft Regulation are as follows:
- In medical device clinical research, both the Draft Regulation and the provisions of the Medical Device Regulation regarding clinical research will be applied.
- Additional measures set forth under the Medical Device Regulation can be applied to people who are in a hierarchical structure, or whose self-protection ability and autonomy are limited or reduced due to economic, social and medical reasons.
- Many issues such as clinical trial application, post-marketing studies, reporting adverse events and important changes in clinical research have been amended to comply with the Medical Device Regulation. In this context, the European Database on Medical Devices (EUDAMED) functionality date is taken as a basis, where the rules to be applied until and after this date are also regulated.
- From the submission of all applications and notifications to the TİTCK: (i) for sponsors residing in Turkey, the sponsor itself or a contracted research institution residing in Turkey is responsible; and (ii) for sponsors not residing in Turkey, the legal representative of the sponsor or the contracted research institution residing in Turkey is responsible.
- The progress report of the research should be reported to the TİTCK at least once a year. For short-term research or if necessary, the TİTCK and the Clinical Research Ethics Committee can request a report earlier.
- The Clinical Research Ethics Committees has been appointed to monitor post-marketing studies, which is a new development introduced by the Medical Device Regulation.
- In the event that an emergency security measure is taken within the scope of the research, the new situation and measures taken must be notified to the TİTCK via the electronic application system within seven days.
Stakeholders can submit their opinions via email@example.com until the end of 25 February 2022.
The TİTCK continues its efforts for secondary legislation regarding medical devices within the scope of the new Medical Device Regulation. Companies can follow the TİTCK’s announcements and submit their views on the legislative changes, if any.