The Current State of Medical Device Regulations: Strategies to Support a Successful Technical Documentation Assessment (TDA)
The Current State of Medical Device Regulations: Strategies to Support a Successful Technical Documentation Assessment (TDA)
Here we are, nearly eight years after the publication of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and Medical Devices Regulation (EU) 2017/745 (MDR). As the May 2025 deadlines loom, many manufacturers are facing the reality of what implementing these regulations actually entails. While the manufacturers seem to have been given more […]