Recent Development
The Turkish Medicines and Medical Devices Agency (“TİTCK”) recently published a new draft Communiqué on Notified Bodies Operating in Medical Devices (“Communiqué“), repealing the previous communiqué.
What Does the Communiqué Say?
With the entry into force of the EU Regulation 2017/745 on medical devices and the EU Regulation 2017/746 on in vitro diagnostic medical devices, new obligations were introduced for the new and existing notified bodies operating in the field of medical devices, as well as for the authorities responsible for the appointment, surveillance and tracking of these notified bodies. To ensure harmonization with the European legislation, the TİTCK recently published the draft Communiqué for public consultation on its website.
The draft Communiqué parallels the provisions of EU Regulation 2017/745 and the EU Regulation 2017/746 concerning requirements for notified bodies, as well as application and designation procedures. The full text of the new draft, the regulations taken as basis for the draft, and a comparison chart for the draft and the European legislation are available online here (in Turkish).
Conclusion
The TİTCK continues to harmonize the Turkish healthcare regulations with those of the EU. Companies must carefully review the new draft Communiqué and take note of the new certification procedures.
