Medical device reporting (MDR) regulation outlines reporting requirements for manufacturers, importers, and device user facilities. Each party has specific reporting obligations, including device-related adverse events – deaths, injuries, or device malfunction, to the Food & Drug Administration (FDA).
The FDA is mandated to regulate the safety and effectiveness of medical devices. It receives mandatory reports1 and voluntary reports2 on various issues, including product quality issues, device use errors, or therapeutic failures.
- Mandatory reports submitted by manufacturers, importers, and device user facilities.
- Voluntary reports submitted by healthcare professionals, caregivers, patients, and consumers.
Once submitted, medical device reports (MDRs) are stored in the Manufacturer and User Facility Device Experience (MAUDE) database. These reports enhance post-market device surveillance efforts to safeguard public health and improve patient safety.
What is an MDR? Understanding MDRs Meaning and Their Role in Patient Safety
The FDA receives numerous medical device reports (MDRs) from mandatory and voluntary reporters yearly. Upon receipt of MDRs, the information is reviewed to establish the attribution of the reported adverse event to device use, which is part of their commitment to improve patient safety.
Annual Report Analysis and Its Impact: FDA MDR Reporting Guidance
Medical device reporting is one data source of the FDA’s post-market surveillance efforts. Due to potential data limitations such as report inaccuracy or under-reporting, the agency relies on data from other post-market device surveillance sources. These reports aid the FDA in monitoring device performance, identifying safety concerns related to device use, and contributing to benefit-risk assessments of the devices.
Mandatory Medical Device Reporting Requirements
Medical device reporting regulations obligate manufacturers, device user facilities, and importers to report device issues and device-related adverse events to the FDA.
Responsibilities of Manufacturers and Importers
Manufacturers are required to submit a report to the FDA once they become aware that one of their devices may have caused or contributed to serious injury or death. They should also report to the agency once they learn about a device malfunction that may cause or contribute to death or serious injury.
Importers should also report to the FDA and the manufacturer once they become aware that one of their imported devices may have caused or contributed to serious injury or death. However, their reporting obligation on device malfunction is to the manufacturer only.
Device User Facilities’ Reporting Obligations
Device user facilities (outpatient diagnostic facilities, hospitals, nursing homes, ambulatory surgical facilities, and outpatient treatment facilities) are mandated to report to the FDA any death they suspect was caused by medical device use. Serious injuries related to device use should be reported to the manufacturer, or FDA if the manufacturer is unknown.
For device malfunction, facilities are not obligated to make reports but may submit a voluntary advisory to the FDA about the product problem.
Voluntary Reporting and Its Significance
FDA runs a medical product safety reporting program, MedWatch, which receives voluntary reports from the public.
Encouraging Reports from Healthcare Professionals and Consumers
Though healthcare professionals, patients, consumers, and caregivers are not mandated to report device problems and device-related adverse events, they are encouraged to do so via MedWatch.
How Voluntary Reports Contribute to Device Safety
Manufacturers release hundreds of new devices into the market each year. Despite the stringent requirements to test the products before release, defective devices and product failure often occur post-release. Voluntary reporting by healthcare professionals and consumers ensures prompt action – advisory or product recall, as necessary – which helps promote device safety.
Detailed Guide on How to Report a Medical Device Problem
Manufacturers must submit an MDR report to the FDA no later than 30 days after learning their device has caused or contributed to the death or serious injury or has malfunctioned and a similar device is likely to cause an adverse event (death or serious injury) if it malfunctions.
An importer must report to the manufacturer and FDA no later than 30 days after learning a device they market has caused or contributed to the death or serious injury. They must also report to the manufacturer within 30 days of learning about a device malfunction, and if a similar device is likely to cause an adverse event (death or serious injury) if it malfunctions.
A user facility must report to the manufacturer and FDA within ten days after learning a device may have caused or contributed to serious injury or death.
Manufacturers and importers should submit reports in electronic format for processing, reviewing, and archiving using Form 3500A. User facilities may submit their reports electronically or on paper using Form 3500A. For additional guidance, the FDA MDR Reporting Guidance provides step-by-step instructions on mandatory reporting obligations and submission requirements. You can also call (301) 796-6670 or email MDRPolicy@fda.hhs.gov for further inquiries.
Step-by-Step Reporting Process for Consumers and Professionals
Healthcare professionals and consumers wishing to make a voluntary report can do so through MedWatch via either of these ways:
- Fill out the MedWatch voluntary reporting form here
- Download, complete, and submit the relevant form (3500 or 3500B) here.
Reporting for Devices Licensed as Biological Products
Medical devices licensed as biological products are subject to the MDR regulation. However, while the Center for Devices and Radiological Health (CDRH) regulates most medical devices, the Center for Biologics Evaluation and Research (CBER) is responsible for regulating devices such as in vitro diagnostic (IVD).
Navigating the Medical Device Reports Database
MDRs sent to the FDA are stored in the Manufacturer and User Facility Device Experience (MAUDE) database.
Accessing and Understanding MAUDE Database
MAUDE database contains reports from different sources as follows:
- Mandatory manufacturer and importer reports: From August 1996 to date
- Mandatory user facility reports: From 1991 to date
- Voluntary reports: From June 1993
To request an MDR report, you may submit a Freedom of Information Act (FOIA) request online or in writing (see instructions here).
Additional Resources for Medical Device Report Search
For additional resources on MDR search, the information is available on the MDR Data Files page here.
Contact and Additional Resources
Below are more links to additional resources and information.
Reaching Out for General Queries
The Division of Industry and Consumer Education (DICE) attends to inquiries on medical devices and can be reached by phone at 1(800) 638-2041 or (301) 796-7100 or by email at DICE@fda.hhs.gov.
Exploring Further Educational Materials on MDR
Also, check out the following resources for additional information about MDR.
- CDRH Learn
- Electronic Medical Device Reporting
- More information on MDR reporting
- Mandatory Reporting Requirements
- MAUDE database
- MDR Database Search
- MedWatch Online Voluntary Reporting
CBS: Your Practice’s Missing Piece
CBS Medical Billing & Consulting is here to help if you need assistance navigating medical device reporting.
