EU MDR · Expert · 13 min lesson
Establishment registration, device listing, MDR reporting and corrections and removals
21 CFR part 807 (registration and listing), part 803 (medical device reporting), part 806 (corrections and removals), QMSR section 820.10(b)
What you will learn
- Explain who must register an establishment and list devices with FDA, and when registration and listing are due.
- Decide whether an event is reportable under 21 CFR part 803, who reports, and by which deadline.
- Decide when a correction or removal is reportable under part 806 and what to record when it is not.
Key takeaways
- Register within 30 days of starting activity and renew every year between 1 October and 31 December; keep the listing current (part 807).
- MDR: manufacturers report within 30 calendar days of awareness (803.50), or 5 work days when remedial action is needed (803.53).
- The clock starts when the firm has information that reasonably suggests a reportable event, not when the complaint is closed.
- Part 806: report a correction or removal that reduces a risk to health within 10 working days; keep records of all actions (806.20).
- A written MDR procedure and a dated, signed decision in an event file for every evaluated event are required (803.17, 803.18).
Free practice question
Calder's regulatory lead notices that the establishment registration was last confirmed in November 2023. It is now March 2026. A colleague says the registration stays valid indefinitely once made.
What is the correct position?
The colleague is right; registration is permanent.
Not quite. Registration must be renewed every year under 21 CFR part 807, so permanence is wrong.
Registration must be renewed each year between 1 October and 31 December, and the missed renewals must be corrected.
Correct. Annual renewal in that window is required under 21 CFR part 807, whether or not information has changed.
Registration is renewed only when a 510(k) is filed.
Not quite. Renewal is annual and independent of premarket submissions under 21 CFR part 807.
Registration renewal is the distributor's job.
Not quite. The owner or operator carries the registration duty under 21 CFR part 807 and cannot hand it to a customer.
Key terms
- establishment registration: The annual notification to FDA by the owner or operator of a device establishment under 21 CFR part 807.
- device listing: The list of devices made at a registered establishment, with the premarket submission number where one exists.
- MDR: Medical device reporting under 21 CFR part 803 of deaths, serious injuries and certain malfunctions.
- becoming aware: The point at which the firm has information that reasonably suggests a reportable event; the reporting clock starts here.
- serious injury: An injury that is life threatening, results in permanent impairment, or needs medical or surgical intervention to prevent such impairment (21 CFR 803.3).
- correction: Repair, modification, adjustment, relabeling, destruction or inspection of a device without physically removing it from its point of use (21 CFR 806.2).
- removal: Physical removal of a device from its point of use to another location for repair, modification, adjustment, relabeling, destruction or inspection (21 CFR 806.2).
- US agent: The person in the United States designated by a foreign establishment to communicate with FDA.
Official sources
- FDA - Device registration and listing
- FDA - When to register and list
- Federal Register - Medical Device Reporting and Corrections and Removals, 21 CFR parts 803 and 806 (1997)
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.