When does a complaint become a reportable event?
A complaint becomes reportable when the event it describes meets a regulator's definition of a reportable event, and the reporting window runs from the day you became aware of it. In the United States, 21 CFR Part 803 asks manufacturers to report deaths, serious injuries and malfunctions that would be likely to cause or contribute to one if they recurred, within 30 calendar days; under the EU MDR, Article 87 asks for serious incidents to be reported within 15 days of awareness, and sooner in some cases. A person decides what is reportable; MDARIX keeps the clock and never submits a report.
This page is general information, not legal or regulatory advice. Check the current official text and your own procedures before you rely on it.
United States: 21 CFR Part 803
- A manufacturer reports when it becomes aware of information that reasonably suggests that one of its marketed devices may have caused or contributed to a death or serious injury, or has malfunctioned and the malfunction would be likely to cause or contribute to a death or serious injury if it were to recur (21 CFR 803.50).
- The report is due within 30 calendar days of becoming aware of the event (21 CFR 803.50).
- A report is due within 5 work days instead when an event needs remedial action to prevent an unreasonable risk of substantial harm to the public health, or when FDA has asked in writing for 5-day reports (21 CFR 803.53).
European Union: MDR Article 87
- A serious incident is an incident that directly or indirectly led, might have led or might lead to a death, a temporary or permanent serious deterioration of a person's state of health, or a serious public health threat (Article 2(65)).
- Serious incidents are reported immediately after the manufacturer has established a causal relationship with its device, or that one is reasonably possible, and no later than 15 days after becoming aware of the incident (Article 87(3)).
- For a serious public health threat: immediately, and no later than 2 days after becoming aware of it (Article 87(4)).
- For a death or an unanticipated serious deterioration in a person's state of health: immediately after a causal relationship is established or suspected, and no later than 10 days after becoming aware of the serious incident (Article 87(5)).
Why the awareness date matters
Every window counts from the day you became aware, so a complaint filed in the wrong category, or reviewed late, uses up time. A complaint closed as an inquiry or as no fault found can still describe a reportable event, and a complaint that names a death or serious injury needs a reportability decision whatever its category.
What MDARIX does
- Counts each complaint's reporting windows from the day you became aware, using the windows your procedure sets. Templates for FDA, EU MDR, UK and Canada reporting keep their basis (21 CFR 803.50 and 803.53, EU MDR Article 87, UK MDR 2002, SOR/98-282).
- Shows which clocks are due, overdue or missing answers, and keeps each reportability decision with the named person who made it and their reason: reported, with the report reference and filing date, or not reportable.
- Brings complaints closed as inquiries or no fault found back for a second look, so a reportable event is not lost in the wrong category, and flags a death or serious injury closed without an investigation.
- MDARIX never decides reportability and never submits anything to a regulator: you record what was filed in the authority's own system.