The Turkish Medicines and Medical Devices Agency (“TMMDA”) published one new communiqué, three new regulations, and one new guideline between 17.08.2024 and 23.08.2024. In general, these TİTCK regulations have been enacted to align with the recently published and enforced regulations in the European Union (“EU”).
In this article, we have highlighted the aforementioned TMMDA. regulations.
1. Communiqué on Determining Common Specifications for Certain Class D In Vitro Diagnostic Medical Devices
As known, the Regulation on In Vitro Diagnostic Medical Devices, prepared in line with the European Union (“EU”) legislation, is currently in force in our country.
Meanwhile, during this process, the common technical specifications for certain devices within the scope of the EU Directive 98/79/EC have been updated under Regulation 2017/746 to reflect current technology and public health and patient safety. The aforementioned Commission Regulation No. 2022/1107 dated 04.07.2022 entered into force on 25.07.2024.
In this context, within the scope of harmonization efforts with the said EU regulations, the Communiqué on Determining Common Specifications for Certain Class D In Vitro Diagnostic Medical Devices was published in the Official Gazette dated 17.08.2024 and entered into force.
2. Amendments to Medical Device Regulations
The Regulation on Amending the Medical Device Regulation and the Regulation on Amending the In Vitro Diagnostic Medical Device Regulation were published in the Official Gazette on 17.08.2024.
As is known, Regulations No. 2017/745, 2017/746, and 2024/1860 prepared by the European Commission were published and entered into force in the Official Journal of the European Union on 09.07.2024. These regulations aim to:
Reduce the risk of unavailability of high-risk in vitro diagnostic medical devices (IVD) under certain conditions.
Mandate the gradual use of relevant EUDAMED modules starting from the last quarter of 2025, immediately after it is announced that the EUDAMED modules have become operational.
Introduce a new obligation for prior notification in cases where devices covered by MDR and IVDR, whose supply disruptions would pose a serious threat to public health or patients, are anticipated to face supply interruptions.
In this context, amendments have been made to the “Medical Device Regulation” and the In Vitro Diagnostic Medical Device Regulation in order to ensure that the relevant EU legislation referenced above is also valid and harmonized in our country.
3. Regulation on the Reclassification of Certain Non-Medical Active Product Groups
The 2017/745 EU Regulation mentioned above and the 2022/2347 EU Regulation, which sets out the implementation principles of this Regulation, have reclassified certain active product groups. This classification aims to subject non-medical active products to a conformity assessment consistent with their structural risks before they are placed on the market.
In line with these EU Regulations, the "Regulation on the Reclassification of Certain Non-Medical Active Product Groups" was prepared and published in the Official Gazette on 17.08.2024 and entered into force.
4. Guideline on the Implementation of Provisions of the Regulation on Technical Service for Medical Devices Used in Health Service Provision
Finally, the announcement on TİTCK's website dated 23.08.2024 stated that the Guideline on the Implementation of the Provisions of the Regulation on Technical Service for Medical Devices Used in Health Service Delivery (“Guideline”) has been published.
The first version of the Guideline outlines the procedures and principles for the implementation of the Regulation on Technical Service for Medical Devices Used in Health Service Delivery, which was published in the Official Gazette on 26.05.2023.