Turkish MDR and IVDR Amended

On 2 April 2023,  regulations amending the Turkish Medical Device Regulation (Turkish language) and the Turkish In Vitro Medical Device Regulation (Turkish language) were published in the Official Gazette numbered 32151.  They amend he transitional provisions stipulated in the which was published in the Official Gazette numbered 31499 to be in line with the transitional provisions applicable to  Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).  

The amendments to the transitional provisions follow Regulation (EU) 2023/607 amending the MDR and IVDR as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices, which entered into force on 20 March 2023 (see Legal update, Regulation extending transitional provisions in MDR and IVDR enters into force). In order to implement these changes , the Turkish Medicines and Medical Devices Agency prepared the amending regulations respectively.

As a result, relevant  devices can now benefit from extended transitional periods, subject to fulfilling the listed conditions, in order to be able to prevent product shortages.

First published by Practical Law Life Sciences Monthly Newsletter in Apr 27, 2023.

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