EU Medical Device Regulation (MDR): The Useful Guide To Labeling Compliance

Compared to the previous European Regulation MDD, the new EU MDR/EU IVDR offer a change from the pre-approval stage to a life-cycle approach. One of the new aspects of the legislation is the introduction of Unique Device Identifiers (UDI) to products, allowing the ability to trace a device from its manufacturer through the supply chain to the final end user. Whether producing medical devices within Europe or supplying to Europe from the rest of the world, as a manufacturer or supplier, you will need to adhere to the new EU MDR/EU IVDR. This article offers useful guidelines for adhering to the new EU MDR/EU IVDR. Download the full paper for more information.