Current Medical Device Reporting Requirements
The Medical Device Reporting Regulation (MDR) 21 CFR 803, contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA. With the establishment of the unique device identification system (which includes a UDI), you might be wondering what steps are necessary to stay within FDA compliance.
All of these requirements can be effectively reached through implementing UDI in JD Edwards. Some features that JDE offers are totally out of the box, so you may need to change some processes, create additional reports, and purchase compatible hardware for bar-coding.