2021/ÜTSG-6 DEFERRED ANNOUNCEMENT REGARDING ÜTS REGISTRATION PROCESS OF OTHER CLASS I PRODUCTS


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  • 2021/ÜTSG-6 DEFERRED ANNOUNCEMENT REGARDING ÜTS REGISTRATION PROCESS OF OTHER CLASS I PRODUCTS

2021/ÜTSG-6 DEFERRED ANNOUNCEMENT REGARDING ÜTS REGISTRATION PROCESS OF OTHER CLASS I PRODUCTS

As it is known, the Medical Device Regulation entered into force in the Official Gazette dated 02.06.2021 and numbered 31499. In this context, announcements regarding the status of products with Class I-Other risk classes in the Product Tracking System (ÜTS) were published. In this context, with the "Announcement Regarding the Product Registration and Single Movement Processes to be Carried out in the Product Tracking System (ÜTS) when the 2021/ÜTSG-4 New Medical Device Regulation enters into force", for products with risk class I-other; It has been stated that manufacturers and importers must update the product registration by registering the EU Declaration of Conformity document, which is issued in accordance with the new legislation, on the ÜTS, otherwise, the product registrations of Class I-Other products that are not updated will lose their validity as of 26.08.2021. However, within the scope of the relevant Announcements, 26.08.2021, which was stated as the date on which the registration of the products will be dropped, has been extended until 31.12.2021, in order to avoid unjust treatment due to the large number of Class I-Other products affected by the process and the workload during the UTS registration application stage. In this direction, the issue of updating the necessary products until the relevant date; It is announced to the interested parties.