Manufacturer vs Importer vs User Facility Obligations
Manufacturer obligations (21 CFR Part 803 Subpart E)
Manufacturers must report all three MDR event types — deaths, serious injuries, and malfunctions. Manufacturers must also:
- Establish, maintain, and implement written MDR procedures
- Establish and maintain MDR event files for each reported event
- Submit baseline reports (FDA Form 3417) for devices associated with reported MDRs
- Submit an annual baseline report if required
Importer obligations (21 CFR Part 803 Subpart D)
Initial importers must report:
- Deaths — to both FDA and the device manufacturer
- Serious injuries — to the manufacturer (or FDA if manufacturer unknown)
- Malfunctions — to the manufacturer (not directly to FDA)
Importers must also maintain complaint files and documentation supporting their MDR decisions.
User facility obligations (21 CFR Part 803 Subpart C)
Device user facilities (hospitals, ambulatory surgical centers, nursing homes, and outpatient diagnostic/treatment facilities) must report:
- Deaths — to FDA (MedWatch 3500A) and the manufacturer within 10 working days
- Serious injuries — to the manufacturer (or FDA if manufacturer unknown) within 10 working days
- Malfunctions — not required for user facilities
User facilities must also submit an annual report (FDA Form 3419) by 1 January each year summarising all MDR reports submitted during the previous year.