Amendments To The Turkish MDR and IVMD Entered Into Force

Amendments To The Turkish MDR and IVMD Entered Into Force

Amendments To The Turkish MDR and IVMD Entered Into Force

The Regulation amending the Medical Device Regulations was published on April 2,2023 in the Official Gazette numbered 32151.

As part of the EU's efforts to comply with current medical device regulations, the Medical Device Regulations (MDR) and In Vitro Diagnostic Medical Device Regulations (IVMD) have been amended in line with the Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023.

On March 20, 2023, the amendments as to the transitional provisions entered into force. In this regard, the devices regulated as per Directive no. 90/385/EEC and 93/42/EEC may be offered to the market until the dates mentioned below and upon the fulfilment of below conditions;

  • Class III devices and implantable devices except for sutures, staples, dental fillings, dental brackets, dental crowns, screws, nails, plates, wires, pins, clips, and connectors until December 31, 2027;
  • Class IIb devices other than those covered above, Class IIa devices, and Class I devices placed on the market in a sterile state or with a measuring function until December 31, 2028;
  • Devices for which conformity assessment procedures under Directive 93/42/EEC do not require the involvement of a notified body, and which have a declaration of conformity issued before May 26, 2021, and for which conformity assessment procedures require the involvement of a notified body under MDR until December 31, 2028.

Sources:0

https://www.titck.gov.tr/duyuru/tcokka-tibbi-cihaz-yonetmeliklerine-degisiklik-yapilmasina-dair-yonetmelikler-03042023123427

https://www.titck.gov.tr/duyuru/tcokka-ab-2023-607-sayili-tuzuk-20032023160117

© 2019 Deriş - All Rights Reserved