Medical device reporting (MDR) is one of the post market surveillance tools used by the FDA to monitor medical devices’ performance post release (21 CFR part 803) [1]. The main purpose is to detect potential device-related safety issues and conduct benefit-risk assessments on them [1]. Each of these reports is reviewed, individually, by the FDA and are additive evidence for benefit-risk assessments that can be conducted when the FDA sees fit.
Manufacturers, importers, and device user facilities are required to report certain safety issues related to the medical device that they have affiliation with. Manufacturers report directly to the FDA and both importers and device user facilities report directly to the FDA and the manufacturer. This chain of command is important for all of the parties involved to properly deal with the possible safety issues of the medical device.
To report an issue with your medical device, the FDA has an electronic submission gateway (ESG) that will allow you to submit MDRs to their database (eMDR), making post market surveillance easier. The ESG has two main options for e-submissions of MDRs which are low volume (WebTrader) and high volume (AS2 gateway software system) allowing for eased use dependent on the user needs [2].
If you need support to report any issue with your medical device, or just simply want to meet FDA compliance, the team of experts at EMMA International can help! Contact us today at info@emmainternational.com or by calling 248-987-4497.
[1] FDA. (2018, June 29). Medical Device Reporting (MDR): How to Report Medical Device Problems. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems#overview
[2] FDA. (2021, November 03). How to Enroll in eMDR Program. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/emdr-electronic-medical-device-reporting/how-enroll-emdr-program
