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Complaint Form

Complaint handling template

Complaint Form for medical device complaint and vigilance management

Use this editable Complaint to capture, evaluate, investigate and close complaints with traceable decisions and clear reporting routes.

Capture complaints consistentlyRecord awareness dates, device traceability and evaluation rationale.
Link to vigilanceIdentify reportable events and feed trend analysis.
Close the CAPA loopConnect complaint findings to corrective and preventive actions.

  • Best for: complaint handling, vigilance reporting, PMS data capture and trend analysis.
  • Includes: editable sections for complaint intake, evaluation, investigation, closure and reporting.
  • Format: editable template available through the standard WooCommerce download flow.
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Lexqara supports manufacturers in turning complaint data into actionable PMS insights while meeting MDR vigilance obligations. Explore the Resource Center or review our Post-Market Surveillance Services.

Description:
This Complaint form captures, evaluates, investigates, and closes complaints with traceable decisions and documented actions.

  • Record Awareness date and Complaint initiation date for timeline control.

  • Capture Device range involved and Traceability including UDI, model, and lot/serial.

  • Perform Complaint Evaluation (yes/no criteria) with written Justification.

  • Document Complaint Reporting to Authorities and link SOP-VIG-001 for Europe.

  • Record Complaint Investigation (DHF/DHR/DMR/QMS, testing) and conclusion.

  • Complete Risk Estimation against the Risk Management File and decide on CAPA.

  • Document Corrections and Response to the complainant with responsibilities and dates.

Your needs:

  • Medical device complaint form

  • Medical device complaint form for ISO 13485, MDR compliance.

  • Reduce rework, protect vigilance timelines, and strengthen audit readiness.

Use this form whenever a complaint is received to ensure intake, evaluation, investigation, and closure are consistently documented and traceable under EU complaint handling and vigilance expectations.

It consolidates the evidence trail. Awareness date anchors regulatory timelines; it matters because late escalation creates reporting risk. Traceability (UDI/lot/serial) links the issue to affected devices; it matters because it supports containment and trend review.

  • Capture complainant details and complaint description.

  • Record device identifiers and traceability fields.

  • Apply complaint criteria with justification and conclusion.

  • Assess reportability for Europe and attach vigilance decision records.

  • Plan and document investigation steps and outcomes.

  • Perform risk estimation and justify CAPA decisions.

  • Record corrections, communications, and closure approvals.

At Lexqara, we align complaint files with PMS workflows, CAPA linkage, and inspection-ready documentation—supported by training and practical templates. Resource Center [https://lexqara.com/resource-center] and Post-Market Surveillance support [https://lexqara.com/services/post-market-surveillance]. EU MDR (Regulation (EU) 2017/745) [https://eur-lex.europa.eu/eli/reg/2017/745/oj]. Download the template or request a short gap assessment.

Template preview

Template preview: Complaint

Review the key sections included in the Complaint template before downloading it. This preview shows the structure and content you will receive in the editable file.

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Complainant Details

Name:

Adress:

Phone number:

Email:

Complaint Details

Awareness date:

[DD-Mon-YYYY]

Complaint initiation date:

[DD-Mon-YYYY]

Description of the complaint

Full description of the complaint

Device range involved:

Traceability

Model number

Lot/Serial Number

UDI

History of exchanges

[DD-Mon-YYYY]

Description of the exchanges / indicate the dates of emails sent when no responses are received. / emails can be attached in Attachment A-X

[DD-Mon-YYYY]

Description of the exchanges / indicate the dates of emails sent when no responses are received. / emails can be attached in Attachment A-X

Complaint Evaluation

If one “yes” is selected, the event meets the definition of complaint[1]

Name

Date

Was the event due to a device malfunction or device deterioration in the device characteristics or performance?

Yes No

Was the event an use-error due to ergonomic features?

Yes No

Was the event due to an inadequacy in the information supplied by the manufacturer? e.g., IFU, labels, identification, traceability

Yes No

Did the event lead to undesirable side-effects or injuries?

Yes No

Was the event related to a service that affected the device characteristics or performance? FOR DEVICES REQUIRING SERVICING (or remove)

Yes No

Did the event lead to a harm as a consequence of a medical decision, action taken or not taken on the basis of information or result(s) provided by the device. FOR IVD (or remove)

Yes No

Justification

Describe in detail when the event is not considered as a complaint or N/A

Conclusion

The event does not meet the definition of complaint. The next sections are not applicable, and the complaint can be closed after a response has been sent to the complainant (see below)

The event meets the definition of complaint.

Complaint Reporting to Authorities

Name

Date

Country

Initial Reporting Criteria

Applicable

Conclusion*

Europe

Did the event occur in Europe?

Yes

Complete SOP-VIG-001

No

Not reportable – trend

Date of reporting to authorities:

Applicable

Non-Applicable

Regulatory Authority

Initial/FU/Final Report

Date

[DD-Mon-YYYY]

[DD-Mon-YYYY]

[Or N/A]

*Supporting evidence are in Appendix B-X of the document.

Complaint Investigation

Name

Date

Need of investigation?

Yes No

Justification when no investigation is required:

e.g., recurrent issue with problem already known

Has(ve) the device(s) been returned?

Yes No

Detailed investigation

Assessment

Applicable?

Description

Complete?

DHF documents

Yes No

Include a justification if “No”

Complete the investigation with a complete description and with reference to records generated (to be included in Attachment A-X)

Yes

DHR documents

Yes No

Include a justification if “No”

Complete the investigation with a complete description and with reference to records generated (to be included in Attachment A-X)

Yes

DMR documents

Yes No

Include a justification if “No”

Complete the investigation with a complete description and with reference to records generated (to be included in Attachment A-X)

Yes

QMS documents

Yes No

Include a justification if “No”

Complete the investigation with a complete description and with reference to records generated (to be included in Attachment A-X)

Yes

Suppliers / Subcontractors

Yes No

Include a justification if “No”

Complete the investigation with a complete description and with reference to records generated (to be included in Attachment A-X)

Yes

Test of the device involved

Yes No

Include a justification if “No”

Complete the investigation with a complete description and with reference to records generated (to be included in Attachment A-X)

Yes

Additional tests

Yes No

Include a justification if “No”

Complete the investigation with a complete description and with reference to records generated (to be included in Attachment A-X)

Yes

… (others)

Yes No

Include a justification if “No”

Complete the investigation with a complete description and with reference to records generated (to be included in Attachment A-X)

Yes

Has a field safety issue been identified?

No, no field safety risk identified

Yes, the complaint may require a FSCA:

HHE: [HHEYYYY-XXX]

Conclusion of the investigation

Following the investigation, the complaint cannot be confirmed as:

  • [XXX] e.g. the device has not been returned

Following the investigation, the complaint has been confirmed, and the following summarizes the cause(s) identified:

  • the device failed to meet its specifications / the device complies with its specifications
  • the device was in use during the event / the device was not in use during the event
  • the device caused or contributed to the event / the device did not cause or did not contribute to the event
  • the following cause has been identified: [XXX] OR N/A

Risk Estimation & Corrective Actions

N/A, the complaint cannot be confirmed, and the investigation cannot conclude on the cause.

Name

Date

Risk Management File:

[Doc+rev]

Identified risks:

Risk

Risk Management File

Complaint Received

Justification and conclusion

Severity

Likelihood

Severity

Recurrence

e.g., recurrence: number of events out of devices sold until today; isolated case

e.g., Severity of complaint: harm for the patient/user

Need of CAPA?

Yes

CAPAYYYY-XXX

No

Include a justification based on the risk estimation consistent with the risk management file / CAPA already initiated for the same problem (CAPAYYYY-XXX)

Corrections

Action with the complainant

Responsible

Date

Record

Possible actions: exchange, servicing, etc.

Response to the complainant

Corrective Actions

Name

Date

Need of CAPA?

Yes

CAPAYYYY-XXX

No

Include a justification based on the risk estimation consistent with the risk management file / CAPA already initiated for the same problem (CAPAYYYY-XXX)

Approval

intermediary

Closure

Name

Signature

Position

Date

List of Attachments

Description

Attachment A-X

Reporting of complaints

Attachment B-X

SOP-VIG-001 – MDR vigilance instruction

Attachment A-1

Attachment B-X

  1. The term “complaint”, as defined in ISO13485, may be referred differently under applicable regulatory requirements (e.g., “incident” under MDR/IVDR). However, the criteria defined under “complaint” encompass all regulatory requirements within scope of [Company Name]’s quality management system. ↑

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