Impact on liability of medical device distributors

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Important Supreme Court order on interpretation of medical device distributor liability The Court of Cassation issued an order on March 6, 2023, number 6568, which could have a significant impact on all distributors of medical devices or in vitro diagnostics that are part of multinational corporate groups. Specifically, the Supreme Court asked the Court of…

The obligations of importers and distributors under MDR

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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…