Amendments to harmonize Türkiye’s medical device regulations with European Union (EU) standards were officially published on August 17, 2024, ensuring compliance and applicability within the country.
On August 20, 2024, the Turkish Medicines and Medical Devices Agency (TİTCK) announced through its official website that significant amendments have been made to the Regulation on Medical Devices and the Regulation on In Vitro Diagnostic Medical Devices (collectively referred to as the “Regulations”). These changes are part of an ongoing effort to align Turkish medical device regulations with those of the European Union (EU) .
The original Regulations, which came into effect after being published in the Official Gazette on June 2, 2021, were based on EU Regulations 2017/745 (MDR) and 2017/746 (IVDR). However, recent updates to EU legislation necessitated corresponding amendments to Türkiye’s regulations.
Recent Changes in EU Legislation
On December 1, 2022, the European Commission introduced new provisions under Regulations (EU) 2023/502 and (EU) 2023/503. These provisions focus on the frequency of comprehensive re-assessments of notified bodies to mitigate the risk of medical device shortages. Additionally, Regulation (EU) 2023/2197, published on July 10, 2023, introduced requirements for assigning Unique Device Identifiers (UDIs) for contact lenses, emphasizing the importance of the EUDAMED database. Further amendments were made on July 9, 2024, under Regulation (EU) No 2024/1860, targeting the following key areas:
- Reducing the risk of unavailability of high-risk in vitro diagnostic medical devices.
- Mandatory phased implementation of EUDAMED modules beginning in the last quarter of 2025.
- Introducing new obligations under MDR and IVDR, requiring advance notification for devices that could pose a serious hazard if supply is disrupted .
Conclusion
The amendments to the Regulation on Medical Devices and the Regulation on In Vitro Diagnostic Medical Devices, published in the Official Gazette No. 32635 on August 17, 2024, are designed to ensure that Türkiye’s medical device regulations are fully aligned with current EU standards. These changes reinforce the applicability of these regulations in Türkiye, supporting the country’s integration with European regulatory practices .
