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Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers

This guidance document describes and explains FDA's current regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for device-related adverse events and certain malfunctions. The requirements are contained in the Medical Device Reporting (MDR) regulation at 21 CFR Part 803.

  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

  • 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

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 summary file ID: 947d754df0c44374ed028f707dc9e336
This post is licensed under CC BY 4.0 by the author.