Turkey Amends Medical Device Regulation and In Vitro Diagnostic Medical Devices Regulation

The Turkish Medicines and Medical Devices Agency (“TITCK”) has recently issued two amending regulations and published them in the Official Gazette on July 29, 2022.

Amending Regulation on the In Vitro Diagnostic Medical Devices Regulation

With the Amending Regulation on the In Vitro Diagnostic Medical Devices Regulation published in the Official Gazette dated July 29, 2022, and numbered 31907, regarding the coordinated evaluation procedure for performance studies, it is stipulated that in cases where one of the EU member countries is the coordinating country, the final evaluation report is taken into consideration by the TITCK when deciding on the sponsor’s application under the In Vitro Diagnostic Medical Devices Regulation.

Suspected serious adverse events are reported to TITCK by healthcare professionals, users, and patients. TITCK saves these reports centrally. However, additions have been made to an article in the section of the In Vitro Diagnostic Medical Devices Regulation on reporting serious adverse events and site safety corrective actions. Within the scope of this amendment, TITCK takes appropriate measures, such as organizing targeted information activities, to ensure that healthcare professionals, users, and patients show the necessary sensitivity in submitting such reports.

Pursuant to the amendment, per the Regulation on Medical Diagnostic Devices Used Outside the Body (In Vitro), which was repealed by the notified bodies with Article 107 of the In Vitro Diagnostic Medical Devices Regulation, certificates issued before 25/5/2017 remain valid until the end of the period specified on the certificate. However, certificates issued within the scope of Annex VI of the said Regulation on Medical Diagnostic Devices Used Outside the Body (In Vitro) become invalid as of 27/5/2025. In addition, certificates issued as of 25/5/2017 become invalid as of 27/5/2025. Before the amendment, the year in which the certificates were invalid was set as 2024.

In accordance with the Amending Regulation on the In Vitro Diagnostic Medical Devices Regulation, the devices referred to below may be placed on the market or put into service until the dates specified below, if it continues to comply with the Regulation on Medical Diagnostic Devices Used Outside the Body (In Vitro), which has been repealed, and that there is no significant change in the design and purpose of use of these devices.

Moreover, it is stipulated that the devices that have been issued per the repealed Regulation on Medical Diagnostic Devices Used Outside the Body (In Vitro) and that have a valid certificate in accordance with the above may be placed on the market or put into service until 26/5/2025.

Devices those conformity assessment procedure does not require the inclusion of a notified body under the repealed Regulation on Medical Diagnostic Devices Used Outside the Body (In Vitro) and for which a declaration of conformity has been issued before 26/5/2022 and for which the conformity assessment procedure requires the involvement of the notified body according to In Vitro Diagnostic Medical Devices Regulation may be placed on the market or put into service until the following dates:

- 26/5/2025 for Class D devices,

- 26/5/2026 for Class C devices,

- 26/5/2027 for Class B devices,

- 26/5/2027 for class A devices placed on the market in sterile condition.

In addition, the Amending Regulation on the In Vitro Diagnostic Medical Devices Regulation includes the dates on which devices that are legally put on the market can continue to be kept on the market or put into service as of 26/5/2022.

Finally, it is stipulated that except for the relevant general safety and performance requirements set out in Annex I of the In Vitro Diagnostic Medical Devices Regulation for devices manufactured and used within healthcare facilities, the conditions requested to be provided as a condition of the provision stating that the requirements of In Vitro Diagnostic Medical Devices Regulation will not be applied;

a) Those specified in subparagraphs (b), ©, and (d) to (ğ) of the fifth paragraph of Article 6 until 26/5/2024 (including this date),

b) Those specified in subparagraph (ç) of the fifth paragraph of Article 6 until 26/5/2028 (including this date),

Amending Regulation on the Medical Device Regulation

With the Amending Regulation on the Medical Device Regulation published in the Official Gazette dated July 29, 2022, and numbered 31907, in the part explaining to whom the regulation will not be applied, the products previously specified as products within the scope of the Regulation on Licensing of Medicinal Products for Human Use are detailed and defined as advanced therapy medicinal products including gene therapy medicinal products, somatic cell therapy medicinal products and tissue engineering products.

Moreover, it has been regulated that the reprocessing and reuse of single-use devices should be carried out under the guidelines published by the TITCK in addition to the article regulating this issue within the scope of the Medical Device Regulation.

Accordingly, it is specified that only single-use devices that have been placed on the market per Medical Device Regulation or before 26/5/2021 in accordance with the previous Medical Device Regulation repealed by Article 110 can be reprocessed.

Another amendment is that under the coordinated evaluation procedure for clinical trials in the Medical Device Regulation, in cases where one of the EU member countries is the coordinating country, the final evaluation report will be considered by the TITCK when deciding on the sponsor’s application.

Finally, suspected serious adverse events are reported to TITCK by healthcare professionals, users, and patients. TITCK saves these reports centrally. However, additions have been made to an article in the section of the Medical Device Regulation on reporting serious adverse events and site safety corrective actions. Within the scope of this amendment, TITCK takes appropriate measures, such as organizing targeted information activities, to ensure that healthcare professionals, users, and patients show the necessary sensitivity in submitting such reports.

Esra Temur