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EU Proposes Significant Changes for Importers and Distributors

The EU’s proposed Medical Device Regulation will subject companies within the supply chain to the same rules, differing from the current fragmented national regulation.

An important change in the new supply chain checks system is that each downstream economic operator has to verify that the previous economic operator complies with the MDR requirements. Thus, importers and distributors have to make sure that, prior to placing a device on the market, the manufacturer, the importer and the device itself meet the MDR requirements.

Authors Erik Vollebregt and Arber Gjunkshi of Axon Lawyers outline obligations for importers and distributors in the BONEZONE® article, EU Proposes Significant Changes for Importers and Distributors.