Electronic Reporting: What You Need to Know to Comply with eMDR  

Summary:

eMDR, electronic medical device reporting, is an efficient method of submitting vigilance reports to the Center for Devices and Radiological Health (CDRH) at the FDA. Top medical device manufacturers, distributors, and reprocessors have implemented automated eMDR systems and, as a result, are benefiting from improved data accuracy, faster response from CDRH, and cost savings from the elimination of repetitive data entry, and even paper and shipping costs. An analysis performed by the FDA indicated that companies can save almost 80 percent by submitting reports electronically rather than by paper. Leveraging existing system capabilities will lead to additional incremental savings. Compliance with reporting regulations can be achieved in two ways, via paper reporting or electronic reporting. This paper will focus on the electronic reporting method, specifically the high-volume eMDR solution, as forward-thinking companies are moving away from traditional paper reporting and adopting eMDR as the best practice.