eMDR – Electronic Medical Device Reporting
Update: April 10, 2026
As of April 14, 2025, the ESG NextGen Unified Submission Portal (USP) replaced the legacy WebTrader user interface. This user-friendly web-based platform provides the ability to submit regulatory information to the FDA and track the status through Center receipt.
Overview of Electronic Medical Device Reporting (eMDR)
If you are a manufacturer or importer you must submit reports of individual adverse events to FDA in an electronic format in accordance with 803.12(a) and 803.20 unless granted an exemption under § 803.19. If you are a medical device distributor, you must maintain records (files) of incidents, but you are not required to report these incidents. Electronic reporting is also available to user facilities, but the rule permits user facilities to continue to submit written reports to the FDA.
The FDA’s "Questions and Answers about eMDR- Electronic Medical Device Reporting – Guidance for Industry, User Facilities, and FDA Staff" answers questions related to FDA’s electronic MDR requirement for device manufacturers and importers.
If you are a medical device distributor, you must maintain records (files) of incidents, but you are not required to report these incidents.
