FDA Announces Upcoming eMDR System Enhancements
The U.S. Food and Drug Administration (FDA) has announced upcoming enhancements to the electronic Medical Device Reporting (eMDR) system.
The FDA states that it recognises the importance of providing early notice and predictability regarding potential eMDR system changes, particularly for high-volume submitters. For this reason, the agency is implementing eMDR enhancements on a regular schedule.
The FDA also notes that firms using third-party applications to create eMDR submission files should use the published information to plan system updates. Low-volume firms using the FDA eSubmitter client should note that eSubmitter is updated concurrently with the eMDR system.
Regular Enhancement Schedule
According to the FDA, the expected schedule for future eMDR enhancement cycles is:
announcement of upcoming enhancements in June;
release of the Implementation Package in August;
deployment to pre-production, ESG NextGen Test, in September;
deployment of high-impact enhancements to production seven months after the Implementation Package is released, typically in March of the following year.
The FDA notes that emergency fixes may be implemented outside this schedule and that additional time may be provided where major system changes are required.
Upcoming eMDR Enhancements
The FDA identifies several upcoming eMDR enhancements.
The first relates to the consolidation of eMDR with the Adverse Event Monitoring System (AEMS). For AS2/API submitters, the FDA states that the electronic MDR submission format and destination address will not change. However, there will be minor changes in Ack3 error messages, although parsing will not be affected.
The FDA also states that, with the AEMS consolidation, eMDR will begin rejecting ISO 3166-1 alpha-2 country codes, as these are not compliant with the XML specification. AS2/API submitters should use GENC 3-letter country codes in their submissions.
The document also includes updates related to International Medical Device Regulators Forum (IMDRF) maintenance updates. Adverse Event codes accepted in sections F10 and H6 of Form FDA 3500A have been updated to harmonise with IMDRF 2025 maintenance updates. Further IMDRF 2026 maintenance updates are also planned.
Key Dates
The FDA indicates the following timelines:
11 May 2026 — test deployment to eMDR for AEMS consolidation and country code changes;
8 June 2026 — second test deployment to eMDR;
20 July 2026 — production deployment to eMDR;
September 2026 — test deployment for IMDRF 2026 maintenance updates;
October 2026 — users, including eSubmitter users, can begin using the new IMDRF 2026 codes;
31 March 2027 — AS2/API users should implement the new IMDRF 2025 and 2026 codes.
Impact on Medical Device Manufacturers
For medical device manufacturers, importers and other organisations submitting MDRs electronically to the FDA, these enhancements may require updates to reporting systems, validation processes and internal procedures.
Manufacturers using AS2/API submissions should review whether their systems comply with the August 2024 XML specification, including the use of appropriate country code formats. They should also prepare for the transition to updated IMDRF adverse event codes used in Form FDA 3500A sections F10 and H6.
These changes are particularly relevant for high-volume submitters and firms using third-party applications to create eMDR submission files. Manufacturers should consider testing system updates through eMDR Test and aligning internal timelines with the FDA’s enhancement schedule.
Although eSubmitter users are updated concurrently with the eMDR system, manufacturers should still ensure that internal reporting workflows, coding practices and quality system procedures remain aligned with the latest FDA requirements.
