Home  | About mdi |  Services  | Industries | News & Information | Partners | Contact| Site Map

eMDR – electronic Medical Device Reporting

December 20, 2007

The FDA has notified the medical device industry that they can now make MDR reports via an electronic Medical Device Reporting (eMDR) project provides the capability for electronic data entry and processing of medical device adverse event reports.

The project utilizes Health Level Seven (HL7) Individual Case Safety Report (ICSR) standard to receive medical device adverse events (MDRs). The eMDR application accepts electronic medical device reports via two options, designed for low and high volume reporters. Both options are open to all reporters.

(1) CDRH eSubmitter (CeSub) – CeSub is a free downloadable application that will allow submission of MDR reports one at a time. This option is suitable for low volume reporters. The software contains data elements from the current MedWatch and generates an HL7 ICSR message for each MDR the user generates using the software.

(2) Health Level 7 (HL7) Individual Case Safety Report (ICSR) – This option provides the capability to receive and process electronic MDR files either individually or as a batch and is particularly suitable for high volume reporters. Users of this option submit MDRs formatted as an HL7 ICSR message.

For more information, please see the following links:

http://www.fda.gov/cdrh/cesub/eMDR.html

http://www.fda.gov/cdrh/emdr/healthlvl7.html

http://www.fda.gov/cdrh/emdr/fdaesg.html

or contact mdi at info@mdiconsultants.com

Home  | About mdi |  Services  | Industries | News & Information | Partners | Contact| Site Map