The MDR regulation (21 CFR Part 803) specifies the types of reports and the data elements required in an MDR. An eMDR contains the same data elements. Importers must include the information specified in 21 CFR 803.42. Manufacturers must include the information specified in 21 CFR 803.52. User facilities must include the information specified in 21 CFR 803.32. Although the eMDR Final Rule permits user facilities to continue to submit MDRs on paper, user facilities may instead choose to submit MDRs in an electronic format.
