Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation, in harmonized with EU regulations, have just been published in the Official Gazette dated 02.06.2021.
Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation introduce significant principles and render procedures regarding the medical devices to meet high level of quality and safety standards. Also, we may say that supporting innovation and creating a transparent, robust and sustainable medical device market are the ultimate principles determined by regulations.
In the line of these regulations, some classification rules and classes for medical devices have been changed. The compliance procedures of
medical devices have been tightened with the new principles and certain product groups which were previously listed in the high risk profile have been included in the scope of this new Medical Device Regulation.
In addition to new principles for quality requirements, the clinical follow-up after the release of the medical devices is imposed as an obligation of the manufacturers.
You may access the Medical Device Regulation in Turkish by this link;
You may access the Medical Device for In Vitro Diagnostic Purposes Regulation in Turkish by this link