What is MDR?
MDR stands for Medical Device Reporting. It refers to the requirement outlined in 21 CFR Part 803, which mandates manufacturers, importers, and user facilities of medical devices to report specific device-related adverse events and product problems to the FDA. These reports must be submitted to the FDA using the FDA's MedWatch Form 3500A or an equivalent electronic format.
Information on the requirements for each mandatory reporting group follows:
Medical device manufacturers are required to report to the FDA when they become aware that any of their devices have caused or contributed to a death or serious injury. The specific terms for reporting are defined in 21 CFR Part 803.
Manufacturers are also obligated to report to the FDA when they become aware that their device has malfunctioned and would lead to death or serious injury if the malfunction were to recur.
Importers also have the obligation to report to the FDA and the manufacturer if it is determined that their device has caused or contributed to a patient's death or serious injury.
if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if it were to recur, the importer only needs to report this to the manufacturer.
A “device user facility” is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician’s office. User facilities are required to report suspected death cases related to medical devices to both the FDA and the manufacturer. They are also obligated to report serious injury cases related to medical devices to the manufacturer and directly to the FDA if the manufacturer is unknown.
User facilities are required to submit an annual report to the FDA by January 1st of each year, in accordance with 21 CFR Part 803. This provision does not require user facilities to report device malfunctions. If a malfunction occurs in an imported device, and malfunctions have the potential to cause or contribute to a death or serious injury if it were to recur, user facilities are not obligated to report it. However, they can voluntarily report the product problem through the FDA's safety information and adverse event reporting program called MedWatch.
What is eMDR?
eMDR stands for Electronic Medical Device Reporting. It refers to the electronic submission of medical device reports to the FDA. The FDA published a final rule on Electronic Medical Device Reporting (eMDR).
According to these regulations, manufacturers and importers are required to submit MDRs in an electronic format that can be processed, reviewed, and archived by the FDA. User facilities have the option to submit MDRs through eMDR, but they can still submit MDRs in paper format. Manufacturers and importers had until Aug. 13, 2015 to begin submitting all MDR reports electronically.
The FDA has two options for manufacturers and importers to electronically submit MDRs:
Web Interface using the eSubmitter application
Users can download the eSubmitter application.
Create MedWatch 3500A Electronic Submission Zip File.
Log in to the WebTrader Internet Site for File Submission.
2. AS2 Gateway-to-Gateway using HL7 ICSR XML
Develop or Purchase AS2 Submission System: Users can develop or purchase a system capable of generating HL7 ICSR XML and transmitting it to ESG using the AS2 protocol.
These options provide different methods for submitting MDR reports electronically, allowing for efficient and streamlined reporting to the FDA.
For more detailed information, please refer to the following links:
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