Home›Solutions›MDR Reportability Review
MEDICAL DEVICE MDR REPORTABILITY REVIEW

The complaint file has 3 lines. The hospital record has 400 pages.

Medical device complaint review services read the clinical records behind a complaint and cite the facts a reportability decision turns on: what happened to the patient, the device's involvement, and the intervention required. Your complaint handling team makes the Part 803 decision and documents its rationale.

Click any row → the source page it cites
Complaint read · Case #IME-4812 documented
Adams, Timothy · device complaint records
342 pp / 2 packets received logged
11 duplicate pages removed free
p.140 — wrong patient quarantined
Pages 342 Documents 27 Cited 100%

The regulation is published. So is the inspector who reads the file.

We do not build for a case type until we can name the standard that defines a correct output and the person who grades the file against it. In device complaint handling, both are already published.

The standard and the referee
The rulebook
  • 21 CFR Part 803, the medical device reporting regulation, with its serious injury and malfunction definitions and its 30-day and 5-day clocks
  • 21 CFR §820.198, the complaint handling requirement in the Quality System Regulation, which requires the reportability evaluation to be documented
  • The manufacturer's own complaint handling and MDR decision procedures
  • The EU Medical Device Regulation vigilance requirements, where the device is also CE marked
The referee
  • The FDA investigator on a QSR inspection, who reads complaint files and the reportability rationale behind each one
  • FDA's Center for Devices and Radiological Health, through the MAUDE database and its own signal review
  • The EU notified body and competent authority, on the vigilance side
Complaint handling staff reading hospital records against a 30-day decision clock Flat 10¢/page here, duplicates free
Complaint read · Case #IME-4812 cited 100%
Packet342 pp / 2 packets · 11 deduplicatedlogged
Patient outcomeWhat happened, as documentedcited
Device involvementEvery mention, with contextcited
Intervention requiredDocumented medical or surgical actionflagged
Read delivered · cited 100% · no reportability decision
How it works

3 steps between the records and the decision.

01

Send the complaint records

Hospital records, operative notes, imaging, device history and the complaint intake itself, in any format.

02

We return the read, page-cited

What happened to the patient, every documented mention of the device, and the intervention required, each cited to the page it came from.

03

Your team decides reportability

The Part 803 decision and the documented rationale belong to your complaint handling team. We never decide reportability or file an MDR.

The boundary, in writing

A read of the records, never the reportability decision.

We read and cite what the clinical records document about the patient outcome, the device's involvement, and the intervention required. We do not decide whether an event is reportable, classify a serious injury or malfunction, determine device causality, or file an MDR. Those are your complaint handling team's decisions under Part 803.

Every mention of the device is carried with the surrounding context rather than extracted as a keyword hit. Reportability turns on what the clinician actually documented, and a mention stripped of its context is worse than no mention at all.

Audit trail · Case #IME-4812 exportable
08:12Packet received · 342 pp / 2 packetssystem
08:3111 pages deduplicatedsystem
08:44p.140 flagged — wrong patientsystem
08:54Complaint read complete · read complete · device mentions cited · cited 100%system
09:20Complaint read reviewed · citations verifiedreviewer
09:26Complaint read exported · reportability decision made off-platformreviewer
Every access logged · file deleted 30 days after delivery
Why Medrecords AI

The rules the platform never breaks.

Medrecords AI EVERY LINE CITED
CASE #IME-4812 · ADAMS, T.342 pp
2/14 — ER visit, right knee p.4
4/18 — arthroscopic surgery p.61
p.140 — wrong patient quarantined
Medrecords AI
Read every page · cite every line

HIPAA, under a signed BAA

Every file is handled under our Business Associate Agreement, from the first byte.

Never trains a model

Your records are never used to train any AI model — ours or anyone else's.

Every line cited

If we can't cite it, we don't say it. Every sentence links to its source page.

Deleted after delivery

Files are deleted 30 days after delivery, with a full audit log of every access.

Powered by the platform

4 capabilities behind every complaint read.

The complaint read is 1 deliverable of the same platform that reads, sorts, and cites the whole record.

FAQ

MDR reportability review, answered.

No. The Part 803 decision and the documented rationale behind it are your complaint handling team's, under your own procedures. We read the clinical records and cite the facts that decision turns on.

No. We carry every documented mention of the device with its surrounding context and cite the page. Device causality is an engineering and clinical determination your team makes as part of the complaint investigation.

Because a keyword hit isn't evidence. Reportability turns on what the clinician actually wrote — whether the device was implicated, incidental, or ruled out — and a mention stripped of that context can push a decision the wrong way.

No. Medrecords AI does not retrieve records from providers or facilities. You bring the records you already have — review starts in minutes from upload. Retrieval vendors take days; you can keep yours and still cut the review to minutes.

Send 1 file. We'll tell you what we can read.

No obligation. If the case type is buildable we'll scope it; if it isn't, we'll say so.