Abstract:

It is seen that some of the products used as part of a diagnosis or treatment in the field of health fall under the definition of medical device. It is known that the main goal in the production of medical devices is diagnosis and treatment, although they are produced for different uses and purposes in order to meet a mandatory need in the development process of human history. In the technological change and development of medical devices to the point they have reached today, the scientific curiosity of the opinion holders, as well as, the impact of the experience and knowledge obtained from clinical studies should not be ignored. In the updated legislation on medical devices recently, it is considered to come into prominence that obtaining product-specific clinical data and, clinical follow-up for monitoring the effectiveness and safety of products on the market. In this sense, it has become necessary to conduct clinical investigations at the point of obtaining product-specific clinical data for many medical devices. Turkey will be carried out in the medical device clinical investigation from the Ministry of Health to initiate Turkey Medicine and Medical Devices Agency should be approved. Applications are evaluated within the scope of the Medical Device Clinical Investigation Regulation published in the Official Gazette dated 06.09.2014 and numbered 29111, and In Vitro Diagnostic Medical Device Regulation and Medical Device Regulation published in the Official Gazette dated 02.06.2021 and numbered 31499 (repetitive). In this review, developments in medical device clinical research from past to present, legal regulations and application processes are evaluated. It has been determined that there is no obstacle to the initiation and execution of medical device clinical trials in Turkey, and that there are many facilitating factors in this area.

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