Modifications to Legacy Devices: MDR Guide

Legacy Devices: Guidance on significant changes according to the EU Medical Device Regulation (MDR) 2017/745 Article 120, paragraph 3, of the EU Medical Devices Regulation (MDR) 2017/745, amended by the latest Regulation (EU) 2023/607, states that devices that remain compliant with the AIMDD or MDD can be placed on the market until December 31, 2027,…

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,…