Developments in the field of Medical Devices

After the long-awaited Regulation on Medical Devices numbered 2017/745 (“MDR”), prepared by the EU Commission, has entered into force, Medical Device Regulation, which was designed following MDR, was published in the Official Gazette numbered 31499 on June 2, 2020. Various effective dates have been foreseen for several articles in accordance with the EU transition process to provide a transition period for the new regulations introduced by the Regulation.

The Medical Device Regulation entered into force on the same date as the MDR, to which it is compatible, and announcements of the TMMDA guide industry stakeholders to ensure compatibility with all EU practices. Nevertheless, while it was necessary to plan the compatibility with the MDR in the preparation of the Regulation, it is observed that not all regulations in force i