EU MDR and IVDR: revealing hidden savings in ensuring compliance with device tracking and UDI requirements
This White Paper outlines the major challenges that medical device companies may face when trying to achieve compliance with the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). In addition, it focuses on the part of the MDR and IVDR regulations that deals with device traceability, and reveals lessons to be learned from the FDA's Unique Identification Identification (UDI) Regulation in the United States. Finally, it also provides a list of steps that medical device manufacturers can take to ensure consistent device tracking while also reducing operating costs.
- Track and Trace