Complaint handling and reportability decision guide

What counts as a complaint

ISO 13485 defines a complaint as a written, electronic or oral communication that alleges deficiencies in the identity, quality, durability, reliability, usability, safety or performance of a medical device that has left the organization's control, or in a service that affects its performance. The source does not matter. A phone call to a sales representative, a remark in a service report and a post on social media can all be complaints.

The complaint process

1. Receive and record every communication, with the date the company became aware.
2. Decide whether it is a complaint.
3. Evaluate it for reporting to the regulators, promptly, because the clock is already running.
4. Investigate, unless a similar complaint has already been investigated and the justification is documented. A reportable complaint is always investigated.
5. Act and close. Open corrective action where the cause warrants it, reply to the complainant, and record the outcome.
6. Trend. Complaint data feed risk management, CAPA and management review.

US medical device reporting

Under 21 CFR Part 803 a manufacturer reports when it becomes aware of information that reasonably suggests one of its devices:

• may have caused or contributed to a death or serious injury; or
• malfunctioned, and the malfunction would be likely to cause or contribute to a death or serious injury if it recurred.

The standard report is due within 30 calendar days of becoming aware. A 5-work-day report is required when an event needs remedial action to prevent an unreasonable risk of substantial harm to public health, or when FDA asks for one in writing. Information found later goes in a supplemental report. A serious injury is one that is life-threatening, causes permanent impairment of a body function or permanent damage to a body structure, or needs medical or surgical intervention to prevent either.

Note what decides reportability: the event and the device's possible role, not proof of cause. "We could not reproduce the fault" does not by itself make a death or serious injury non-reportable.

EU vigilance

Under the EU MDR, manufacturers report serious incidents to the competent authority of the country where they happened, and report field safety corrective actions. A serious incident is one that directly or indirectly led, might have led or might lead to a death, a serious deterioration in health or a serious public health threat. The deadlines are counted from awareness and are shorter for deaths, unanticipated serious deterioration and serious public health threats. The EU also requires trend reporting: a statistically significant increase in incidents that are not serious, or in expected side effects, is reported even when no single event is. Check the current regulation and guidance for the exact terms.

Reading the result

The tool follows the US questions in order. A gold outline marks the question still open; an open question does not stop the clock. The trend section compares the rate of similar complaints per 1,000 units with the year before, a simple first look; a formal trend analysis would use the methods in your procedures. Use it with the CAPA tool and the lot traceability record when a complaint points to a lot.

On the exam

CMDA III.D.11 asks you to evaluate complaint handling procedures, including investigation and the determination of medical device reporting and incident reporting. III.D.12 adds service reports that must reach the complaint process, and III.E covers post-market surveillance: vigilance, MDR, adverse event reporting, trend reporting, recalls, corrections and removals. CQE VII.C.4 lists complaint tracking, trending and post-market surveillance as risk monitoring techniques. Expect scenarios that ask whether an event is reportable, which report applies, and what the auditor should look for in a complaint file.

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