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The European Union Medical Devices Regulation 2017/745 (“MDR”) came into effect in all member states as of May 26, 2021, after a one-year delay due to the ongoing Covid-19 pandemic. In parallel, the Regulation on Medical Devices (”Regulation”) and the Regulation on In Vitro Diagnostic Medical Devices of Turkey, which are compliant to the MDR and the EU Regulation on in vitro Diagnostic Medical Devices 2017/746, have been published in the Official Gazette on June 2, 2021. Accordingly, the Regulation on Medical Devices has entered into force to be effective as of May 26, 2021, and the Regulation on In Vitro Diagnostic Medical Devices will enter into force on May 26, 2022.
With this respect, Turkish Medicines and Medical Devices Agency (“TITCK”) has published announcements dated May 25, 2021 to elaborate the scenarios to be applied to Product Tracking System (“ÜTS”) processes concerning the products affected by these changes, and dated July 6, 2021 on continuation of ÜTS registrations for certain products subject to exemptions under the Regulation.
TITCK’s most recent announcement on the subject dated November 16, 2021 is regarding the registration process of products that are subject to a risk class change pursuant to the Regulation and currently not registered in ÜTS.
As certain devices that are released to the market directly by their manufacturers without a conformity evaluation from an approved organization in accordance with Directive 93/42/EEC are subject to a change of risk class, their change in risk classification necessitates the conformity evaluation of an approved organization. The temporary first article of the Regulation stipulates that Class I devices within the scope of the old Medical Devices Regulation for which a declaration of conformity is issued before May 26, 2021 that are subject to a conformity evaluation by an approved organization pursuant to the Regulation shall be allowed to be released to the market until May 26, 2024 provided their compliance with the old regulations persists and there are np significant changes to their design and intended use.
TITCK’s announcement dated July 6, 2021 regarding the devices under “Class-I Other” that has “registered” status in the ÜTS subject to the exemption mentioned above. With said announcement, it was explained that the exemption from the conformity evaluation by an approved organization due to the increase of risk class pursuant to the Regulation is subject to certain conditions. In order to be eligible for continuation of validity of ÜTS registration of the said products, “product description” of the relevant products’ ÜTS registration page were required to be updated as explained in the announcement until August 26, 2021. The registrations of products under Class-I Other risk classification that were not updated in ÜTS as such until this date was annulled.
With the recent announcement TITCK now explains the registration process for devices under Class-I Other whose risk class were increased by the Regulation and that are not currently registered in ÜTS. For these products, first an application including the form and the petition annexed to TITCK’s announcement shall be made through ebs.titck.gov.tr. These applications will be evaluated and ÜTS registrations for approved products will be permitted by TITCK.
(For more details regarding TİTCK’s previous announcement dated May 25, 2021 please see: https://herdem.av.tr/turkey-s-new-approach-to-product-registration-processes-following-amendment-of-medical-device-regulations)
Kortan Berat Gödekoğlu
