New Advertising Regulations for Medical Devices

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,…

MDR Regulation: Translation and repackaging activities

With the adoption of European Regulations 2017/745 MDR (Medical Device Regulation) and 2017/746 IVDR (In Vitro Diagnostic Regulation), the regulation for medical devices and in vitro medical devices has changed dramatically. The main objectives of the 2017/745 European MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) are to “establish a robust, transparent, predictable…

Legacy devices: Instructions and clarifications

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…