In May, the European Union’s sweeping new Medical Device Regulation (MDR) will take effect. (The law had been scheduled to go into effect last May, but was postponed due to the COVID-19 pandemic.)
Among other things, the MDR requires medical device manufacturers to implement a unique device identification (UDI) system like the one mandated by the U.S. Food and Drug Administration in 2013. Under MDR, every medical device is required to bear a unique, globally recognized identifier so it can be tracked from the point of manufacture, through distribution, to final use. The goal of the system is to facilitate medical device recalls; aid adverse event reporting; improve supply chain security; and prevent medical errors.