In this article we are going to analyze the questions and answers regarding the new European Regulation 2017/745 or MDR (Medical Device Regulation). Recall that we are among the first Italian companies to have obtained MDR certifications for some of our medical devices. How are economic operators regulated in the new MDR regulation? In…
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,…