TİTCK Medical Device Regulations Harmonised with the European Union Legislation

On 20.08.2024, the Turkish Medicines and Medical Devices Agency (“TİTCK”) announced on its official website that amendments have been made to the Regulation on Medical Devices and the Regulation on Medical Devices for In Vitro Diagnostic Purposes (together the “Regulations”) in line with the harmonisation efforts with the European Union (“EU”).[1]

The Regulations, which entered into force after being published in the Official Gazette dated June 2, 2021 and numbered 31499 (Repeated), were prepared in accordance with EU Regulations 2017/745 and 2017/746. However, in line with recent amendments to EU legislation, the Regulations have also been amended.

What Has Changed in the EU Legislation?

On 1 December 2022, the European Commission (“Commission”) published Regulations (EU) 2023/502 and (EU) 2023/503, which include new provisions on the frequency of complete re-assessments of notified bodies to reduce the risk of non-supply of medical devices. Furthermore, for the identification and traceability of devices introduced by these new Regulations, Regulation (EU) 2023/2197 on the assignment of Unique Device Identifiers (UDIs) for contact lenses was published on 10 July 2023, aiming to relieve the EUDAMED database. Finally, on 9 July 2024, the Commission published Regulation (EU) No 2024/1860, in which amendments were made primarily for the following purposes:

• Reducing the risk of unavailability of high-risk in vitro diagnostic medical devices,
• Mandatory phased implementation of EUDAMED modules starting from the last quarter of 2025,
• Introducing new obligations under the Medical Device Regulation (EU) 2017/745 (“MDR”) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (“IVDR”) for advance notification of devices that could pose a serious hazard in the event of a supply disruption.

Conclusion

The amendments to the “Regulation on Medical Devices” and the “Regulation on Medical Devices for In Vitro Diagnostic Purposes,” published in the Official Gazette No. 32635 on 17 August 2024, aim to align these regulations with the current EU standards for medical devices and in vitro diagnostic devices, ensuring their applicability in Türkiye.

[1] The full text of the announcement is available here (Only in Turkish).