Latest Advertising Updates for Medical Devices: Regulatory Update from the Ministry of Health Recent updates regarding the advertising of medical devices and in-vitro diagnostic medical devices (IVDM) have led to new regulatory provisions. On March 18, 2023, two decrees from the Ministry of Health, signed on January 26, 2023, were published in the Official Gazette,…
With the adoption of the European Regulations 2017/745 MDR (Medical Device Regulation) and 2017/746 IVDR (In Vitro Diagnostic Regulation), the regulations for medical devices and in vitro medical devices have changed dramatically. The main objectives of the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) are to “establish a robust, transparent, predictable, and…
With the adoption of the European Regulations 2017/745 MDR (Medical Device Regulation) and 2017/746 IVDR (In Vitro Diagnostic Regulation), the regulations for medical devices and in vitro medical devices have changed dramatically. With the MDR (Medical Device Regulation), the figures of economic operators were, at last, regulated; figures that were not fully considered in the…