Electronic Medical Device Reporting

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eMDR1Electronic Medical Device Reporting (eMDR) requires medical device manufactures and importers to submit medical device reports (MDRs) in an appropriate electronic format so the information can then be processed, reviewed, and archived by the FDA. The eMDR final rule will be effective on August 14, 2015.

There are two options for submitting eMDRs: eSubmitter or Health Level 7 Individual Case Safety Reports (HL7 ICSR). Both of these submission options are processed through the secure FDA Electronic Submission Gateway (ESG). Manufacturers and importers should register for an ESG account and complete a test submission to make sure no problems are encountered when making an actual submission. Test submissions will be available beginning on June 29, 2015.

Helpful links for eMDR:
HL7ICSR implementation package
Electronic Submissions Gateway
FDA eSubmitter
Health Level 7 Individual Case Safety Reports
eMDR Guidance