RECORDREFERENCE OUTLINE

Medical Device Report Decision Record

Reportability decision record applying each limb of the Medical Device Reporting test explicitly, including the malfunction limb that turns on likely harm if the malfunction recurred rather than harm that occurred. Covers device preservation, failure-mode investigation, initial and supplemental filing, and feedback into complaint handling and CAPA. Maps to 21 CFR Part 803.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
21 CFR Part 803
DOCUMENT TYPE
Record
LAST UPDATED
August 2026
PURPOSE

Medical Device Reporting is a distinct regime with its own reportability test and its own timetable. The decision that matters is whether the device may have caused or contributed to a death or serious injury, or whether a malfunction would be likely to do so were it to recur. That likelihood judgement is yours, and it is the limb most often answered on what happened instead.

What's Inside

✓Complaint intake with device identification, lot or serial number, and the control status of the returned unit
✓The reportability test applied limb by limb, each limb carrying the reasoning that decided it
✓Investigation steps and findings, ending in the failure mode established or the reason none was
✓Initial and supplemental filing entries with the window applied and the due date calculated
✓Onward actions into complaint handling, CAPA, the risk file and any field action considered
✓A decision not to report, recorded with the same rigour as a decision to report
✓Reviewer approval, so a reportability call is not left as one person’s unreviewed judgement

How to Use It

1Preserve and quarantine the device before investigating; a unit returned to service or discarded removes the evidence that establishes the failure mode.
2Answer the malfunction limb on likely harm were the malfunction to recur, not on whether harm occurred this time.
3Record the reasoning for every limb, including the ones answered no; an unexplained no is the finding, not the conclusion.
4Where reportability is genuinely uncertain, report and state the uncertainty; suppressing uncertain cases is what an inspector reconstructs from your complaint file.
5File the initial report within its window even while the investigation stays open, and carry later findings in a supplemental.
6Feed the established failure mode back into the risk file; a reportable event that changes nothing upstream simply repeats.
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Complaint Intake and Device Control
2Reportability Test
3Investigation and Failure Mode
4Filing and Follow-Up
5Feedback to the Quality System
REGULATORY CONTEXT

21 CFR Part 803 sets the Medical Device Reporting requirements — who must report, the reportability criteria, the submission timetable, and the event files to be kept including for events judged not reportable. It does not decide whether your particular malfunction would be likely to cause harm on recurrence; that judgement belongs to the manufacturer and is tested against the reasoning you recorded at the time. The decision-record structure and the limb-by-limb framing are SPEQ’s practitioner synthesis.

MAPPED STANDARDS
21 CFR Part 803
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