Medical Device Reporting Requirements for User Facilities
This guidance outlines the medical device reporting (MDR) requirements for user facilities (hospitals, ambulatory surgical facilities, nursing homes, outpatient treatment and diagnostic facilities) to report device-related deaths and serious injuries to FDA and/or manufacturers. It implements the Safe Medical Devices Act of 1990 (SMDA) and Medical Device Amendments of 1992.
What You Need to Know? 👇
What are the key reporting requirements for user facilities under MDR?
User facilities must report device-related deaths to both FDA and manufacturers within 10 work days. Serious injuries must be reported to manufacturers only (or FDA if manufacturer unknown). Semiannual reports summarizing all events are due January 1 and July 1.
Which healthcare facilities are considered “user facilities” under MDR regulations?
User facilities include hospitals, ambulatory surgical facilities, nursing homes, outpatient diagnostic facilities, and outpatient treatment facilities. Physician’s offices, school nurse offices, and employee health units are specifically excluded from these requirements.
What constitutes a “serious injury” that requires MDR reporting?
Serious injury means an injury or illness that is life-threatening, results in permanent impairment of body function or damage to body structure, or necessitates medical or surgical intervention to preclude permanent impairment or damage.
Are user facilities required to investigate device-related adverse events?
No. User facilities must only report information that is “reasonably known” to them, including documents in their possession and information from reasonable follow-up within the facility. They are not required to conduct investigations.
What penalties can user facilities face for non-compliance with MDR requirements?
Criminal penalties include up to $1,000 fine and one year imprisonment for first unintentional offense, or $10,000 and three years for subsequent/intentional offenses. Civil penalties may reach $15,000 per violation or $1,000,000 for all violations in one proceeding.
How long must user facilities maintain MDR-related records and files?
User facilities must maintain MDR event files and all related records for two years from the date of the adverse event, whether the event was reported or not. Files must be prominently identified and easily accessible for FDA inspection.
What You Need to Do 👇
Recommended Actions
- Establish written procedures for:
- Identifying and evaluating adverse events
- Determining reportability
- Submitting complete and timely reports
- Implement MDR event files system:
- Create dedicated files for adverse events
- Maintain records for 2 years
- Include evaluation documentation and report copies
- Designate MDR contact person for FDA communications
- Set up process to:
- Submit death reports to FDA and manufacturer within 10 work days
- Submit serious injury reports to manufacturer within 10 work days
- Submit semiannual reports to FDA by January 1 and July 1
- Train relevant personnel on:
- MDR requirements and definitions
- Internal procedures
- Documentation requirements
- Reporting timelines
- Establish system to track reporting deadlines and maintain compliance
- Review and update procedures periodically to ensure continued compliance
Key Considerations
Human Factors
- User/operator errors must be reported if they caused or contributed to a reportable event (death or serious injury)
Safety
- Deaths must be reported to both FDA and manufacturer within 10 work days
- Serious injuries must be reported to manufacturer within 10 work days (to FDA if manufacturer unknown)
- Semiannual reports of deaths and serious injuries must be submitted to FDA by January 1 and July 1
Other considerations
- Written procedures must be established for identifying, evaluating and reporting adverse events
- MDR event files must be maintained for 2 years
- A contact person must be designated for FDA communications
- User facilities must provide all information reasonably known but are not required to investigate events
- Reports must be in English
- Electronic reporting requires prior FDA approval
Relevant Guidances đź”—
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Medical Device Reporting for Needlestick and Other Sharps Injuries
- Voluntary Malfunction Summary Reporting Program for Medical Devices
Related references and norms đź“‚
- No specific norms or ISO standards mentioned in the guidance