Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers

What You Need to Know? 👇

What are the key reporting timeframes for medical device manufacturers under MDR regulations?

Manufacturers must submit 30-day reports for deaths, serious injuries, and malfunctions within 30 calendar days of becoming aware. 5-day reports are required for events necessitating remedial action to prevent unreasonable risk of substantial harm to public health, or when FDA specifically requests such reports.

When is a device malfunction considered reportable under MDR requirements?

A malfunction is reportable when the device fails to meet performance specifications or perform as intended, and the malfunction would be likely to cause or contribute to death or serious injury if it recurred. This includes malfunctions affecting long-term implants, life-supporting devices, or those requiring remedial action.

What constitutes “becoming aware” of an MDR reportable event for manufacturers?

Manufacturers “become aware” when any employee learns of information reasonably suggesting a reportable event, or when management/supervisory personnel with regulatory, scientific, or technical responsibilities recognize events necessitating remedial action to prevent substantial harm to public health.

Are foreign manufacturers subject to US MDR reporting requirements?

Yes, foreign manufacturers of devices cleared or approved for US marketing must comply with MDR requirements. However, FDA generally doesn’t enforce MDR reporting for devices exported under sections 801(e) or 802 unless specific device concerns are identified requiring adverse event information.

What information must be included in manufacturer MDR reports?

Reports must contain patient information, adverse event details, device information, initial reporter information, reporting information including manufacturer contact details, and device manufacturer-specific information. All reasonably known information must be included, obtained through good faith efforts to contact reporters and analyze devices.

Can manufacturers request exemptions from MDR reporting requirements?

Yes, manufacturers can request exemptions, variances, or alternative reporting forms under 21 CFR 803.19. Requests must include firm identification, justification, device details, and estimated affected reports. FDA may grant exemptions with specific conditions to ensure public health protection.

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What You Need to Do 👇

Recommended Actions

1. Establish written MDR procedures covering:
   • Event identification and evaluation process
   • Decision-making criteria for reportability
   • Investigation procedures
   • Reporting timelines and procedures
2. Implement complaint handling system:
   • Train employees on adverse event identification
   • Document investigation of complaints
   • Maintain complete complaint files
3. Set up electronic reporting capability:
   • Register for FDA Electronic Submissions Gateway
   • Implement eMDR system
   • Train staff on electronic submission requirements
4. Create MDR file management system:
   • Establish file structure and retention periods
   • Include all required documentation
   • Enable FDA access during inspections
5. Develop process for:
   • 30-day standard reporting
   • 5-day expedited reporting
   • Supplemental reporting
   • Follow-up investigations
6. Review and update procedures for:
   • Foreign event reporting
   • Contract manufacturer arrangements
   • Literature monitoring
   • Remedial actions
7. Establish quality checks to ensure:
   • Complete and accurate reporting
   • Proper documentation
   • Timely submissions
   • Appropriate follow-up

Key Considerations

Labelling

• Device labeling addressing risks and complications does not exempt from MDR reporting if an event occurs
• Incompatibility issues mentioned in labeling may still require reporting if death or serious injury occurs

Safety

• Must report events that reasonably suggest a device may have caused/contributed to death or serious injury
• Must report malfunctions that would likely cause/contribute to death or serious injury if they recurred
• 30-day reporting timeline for standard reports
• 5-day reporting timeline for events requiring remedial action to prevent unreasonable risk
• Must investigate all complaints of adverse events
• Must maintain MDR files for 2 years or expected device life, whichever is greater

Other considerations

• Must develop, maintain and implement written MDR procedures
• Must establish and maintain complete MDR files in written or electronic form
• Foreign manufacturers exporting to US must comply with MDR requirements
• Contract manufacturers may request exemption from reporting if another firm assumes responsibility
• Must submit reports electronically unless granted exemption
• Must provide FDA access to MDR files during inspections

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Relevant Guidances 🔗

• Medical Device Reporting Requirements for User Facilities
• Medical Device Reporting for Needlestick and Other Sharps Injuries
• Voluntary Malfunction Summary Reporting Program for Medical Devices

Related references and norms 📂

• 21 CFR Part 803: Medical Device Reporting
• 21 CFR Part 820: Quality System Regulation
• 21 CFR Part 806: Medical Devices; Reports of Corrections and Removals
• 21 CFR Part 812: Investigational Device Exemptions

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Original guidance

• Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
• HTML / PDF
• Issue date: 2016-11-08
• Last changed date: 2019-02-09
• Status: FINAL
• Official FDA topics: Medical Devices, Adverse Event Reporting System (FAERS), Postmarket, Adverse Event Reporting
• ReguVirta ID: 947d754df0c44374ed028f707dc9e336