18/07/2022

Online sale of medical devices in Italy: applicable regulatory frameworks

With the entry into force of Regulation 2017/745 (MDR), all doubts have been removed as to whether medical devices can also be sold online. In abstract, medical devices can be sold online through e-commerce sites of one of the economic operators involved in the supply chain (manufacturer, distributor or importer) and in generic marketplaces. Both channels can be directed at consumers and professionals, without distinction. Within this completely liberal framework, however, there are other laws and regulations in force in Italy, different from the MDR, that must be respected in the online sale of medical devices.