Templates and records · ISO 13485 · Clause 8.2.2

ISO 13485 medical device complaints log

Every communication questioning the identity, quality, durability, reliability, usability, safety or performance of a device already released, handled promptly and with the key question: does it need reporting?

In one sentence

A medical device manufacturer's complaints log records receipt, the evaluation of whether the information is a complaint, the investigation or the justification for not investigating, the decision on reporting to the authority, handling of the product concerned and the need for correction or corrective action, because clause 8.2.2 of ISO 13485 requires complaints to be handled in a timely manner under a documented procedure and their records kept.

Content reviewed on 17 October 2026

Where the standard requires it: ISO 13485 · Clause 8.2.2 Clauses are cited using the numbering of ISO 13485:2016, the current edition and the same one the Academy uses.
Type of information: Mandatory record Complaint handling records (8.2.2)
Who fills it in: Quality, with regulatory affairs Customer service or the distributor receives it; regulatory takes the reporting decision
When: As soon as it is received The reportability assessment does not wait for the investigation to finish: MDR deadlines run from awareness of the incident
How long it is kept: Product lifetime, at least two years ISO 13485 requires records to be kept for at least the lifetime of the device as defined by the manufacturer, and never less than two years from release (4.2.5); the MDR requires technical documentation to be available for ten years after the last device was placed on the market, fifteen for implantables (Article 10(8)).

What the standard requires

What ISO 13485 demands and what it leaves to your judgement

The standard requires a documented procedure for timely complaint handling covering at least: receiving and recording the information, evaluating whether it constitutes a complaint, investigating it, deciding whether it must be reported to the authority, handling the product concerned and deciding whether to start corrections or corrective actions.

If a complaint is not investigated, the justification is written down. If it arises from activities of third parties — a distributor, a subcontractor — relevant information is exchanged with them.

ISO 13485 defines a complaint broadly: any communication alleging deficiencies of the device after release. That is why it is not the same as a commercial grievance, even though both may arrive through the same channel.

Read it in context: Measurement, analysis and improvement, in the ISO 13485 Academy

Structure

Fields the template should include

Number, date received and channel
Complainant: professional, patient, distributor
Device, reference, batch or serial number and UDI
Description of the event and consequences for the patient or user
Is it a complaint? Assessment and criterion
Must it be reported to the authority? Decision, date and who decides
Investigation or justification for not investigating
Returned product: receipt, analysis and disposition
Correction or corrective action and its number
Response to the complainant and closure date

Example

Example: complaint about an incorrect reading

Company, people and figures are fictitious: the example only shows what a properly completed record looks like.

Field	Content
Number	COMP-2026-057 · 6 May 2026 · email from a distributor
Device	Oxilite pulse oximeter · serial PX2604119 (fictitious)
Event	SpO2 readings of 85% on a patient measured at 97% in hospital; no harm
Complaint?	Yes: it alleges a performance failure after release
Reportable?	No: no serious incident and no reasonable possibility of recurrence with harm · decided by regulatory on 7 May
Investigation	Returned unit: sensor damaged by a drop · accuracy out of specification
Trend	3 similar complaints in the half-year · analysed in post-market surveillance
Action	CAPA-2026-012 to review drop resistance
Closure	Response to the distributor on 21 May

At the audit

Mistakes auditors commonly flag

Complaints treated as commercial issues that never reach quality.
The reporting decision is taken at the end of the investigation, after the deadline.
Complaints closed with no investigation and no written justification.
No trend analysis across similar complaints.
Returned product that is not analysed or gets lost.

In Kimobox

How this record is kept in Kimobox

1Each complaint is recorded with its analysis, root cause and associated action.
2It is linked to its batch, its cause and its action, ready for a notified body inspection.
3Post-market surveillance is managed with regulatory reporting alerts.
4Management review incorporates complaints and vigilance without building a separate report.

Frequently asked questions

What people ask us before getting started

Must every complaint be reported to the authority?

No. Only those meeting the reporting criteria in the regulations; in the EU, serious incidents under Article 87 of the MDR. But the decision whether or not to report must be taken and recorded for every complaint.

Is a suggestion for improvement a complaint?

No, if it does not allege any deficiency of the device. Even so, ISO 13485 asks for all feedback to be gathered in the 8.2.1 process, because it can feed risk management and improvement.

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