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…
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…
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…
Economic players, new definitions, and the roles players can play in the medical device market With the adoption of 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 regulation, the figures of traders were,…