eMDR System Update

eMDR System Update

eMDR System Adverse Event Codes Update Rescheduled

The eMDR adverse event code update originally planned for April 6, 2018 in the production environment has
been delayed until July 5, 2018. This will provide additional time for AS2 submitters to develop and validate the
necessary changes to their adverse event complaint handling systems using the test eMDR system, which was
updated on March 6, 2018.

The corresponding eSubmitter update will also take place on July 5, 2018. This means that eSubmitter users
will continue to submit using the old adverse event code hierarchies for Device Problem Code (DPC),
Manufacturer Evaluation Method Code (EMC), Manufacturer Evaluation Result Code (ERC), and Manufacturer
Evaluation Conclusion Code (ECC) in F10 and H6 until that date.

More information about this MDR adverse event codes update can be found on FDA.gov at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/eMDR–ElectronicMedicalDeviceReporting/ucm475303.htm

AS2 submitters should also keep in mind that the eMDR system will cease to accept ICSR R1 XML submissions
on July 5, 2018. eMDR and eSubmitter were updated to use ICSR R2 XML on June 29, 2017, and a one-year
grace period was granted for AS2 submitters to continue submitting R1 XML. The sunset date for R1 was
originally July 1, 2018, but it was moved to July 5 to synchronize with the adverse event codes update.

The eMDR implementation package, which contains technical specifications for AS2 system developers, has
also been updated on FDA.gov. The purpose of this update is primarily to correct minor errors and provide
additional clarifying instructions based on questions received by the eMDR Helpdesk.

The eMDR implementation package can be found on FDA.gov at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm127951.htm

Thanks,
eMDR Team