As known; The new Medical Device Regulation (MDR-2017/745) was published in the Official Gazette on 02.06.2021 and the Medical Device Regulation (MDD-93/42) published in the Official Gazette dated 7/6/2011 and numbered 27957 was repealed.

In the new Medical Device Regulation (MDR-2017/745) published on 02.06.2021, some transitional provisions for placing products on the market are included.

Regarding these transitional provisions; Announcements numbered ÜTSG-4[1] and ÜTSG-5[2] have been published on the website of our Institution and on the ÜTS portal.

These transitional provisions have been made according to the risk class of the product and all the details are explained in the relevant announcements. In this manner;

     - Medical devices (Class III, IIb, IIa, I-s, I-m) certified by a notified body before the effective date of the regulation 26/05/2021 will continue to be registered in ÜTS until the certificate expiry date of their EC certificates.

     -Declaration of Conformity issued with reference to the Medical Device Regulation (MDD-93/42) published in the Official Gazette dated 7/6/2011 and numbered 27957, for medical devices (Class I-other) that are placed on the market with a Declaration of Conformity only, as of 26.05.2021. Since then, it has become invalid in terms of placing the products on the market.

     - With our aforementioned announcements, this issue has been shared with our stakeholders and in this respect:

               -For products in Class I-other risk class; Manufacturer and importer companies are required to update the product registration by registering the EU Declaration of Conformity issued in accordance with the new legislation in ÜTS.

               - PRODUCT REGISTRATION OF CLASS I-OTHER PRODUCTS WITHOUT UPDATED PRODUCT REGISTRATION WILL LOSE VALIDITY AS OF 26.08.2021.

In this context, it is very important for manufacturers and importers with products to singularize individual products that have already produced/imported and are in their warehouses in ÜTS. Even if the product records of the products that are singularized on the ÜTS are not updated, the existing singularized products will remain approved in the system and the sale of these products can be made by the relevant companies.

In addition, for products manufactured from products whose product registration has become invalid because the product registration has not been updated, or for products whose country information is imported but is an EU member country, individual product entries can continue to be made with the production and import notification in ÜTS, provided that the production date is 26.05.2021 and earlier. .

There is a transitional provision in the relevant legislation for products with a higher risk class (Class III, IIb, IIa, Is, Im) as per the new regulation, while they are normally Class I-other. If it is entered in the relevant field in the registration, the records of the products included in this group will continue to be valid.

In this respect, it is very important for you to carefully examine the ÜTSG-4 and ÜTSG-5 Announcements and to establish the necessary actions by all our companies within the scope of the issues summarized in this explanation text, and it is respectfully announced to the relevant parties.

[1] Announcement on 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 comes into force (https://uts.saglik.gov.tr/?p=3167) )

[2] 2021/ÜTSG-5 Announcement on Products whose Class has Changed with the New Medical Device Regulation (https://uts.saglik.gov.tr/?p=3197)