Chapter 5 — Receipt, Assessment, Coding, Investigation & Dispatch
Every incoming report must satisfy all four criteria before processing can begin.
Healthcare professional, user, patient, or manufacturer representative who reported the event.
Patient or user affected by the event, identifiable by initials, age, gender, or record number.
Device identified by model number, lot/batch number, serial number, or UDI.
Description of the adverse event, incident, or device malfunction observed.
Five sequential stages from initial receipt through regulatory dispatch.
Verify the four minimum validity criteria against the incoming report. Log the date of receipt as Day 0 and start the regulatory reporting clock for all applicable jurisdictions.
Conduct a medical and technical review of the event. Determine whether the case qualifies as a serious incident or reportable malfunction. Check for the Weber Effect—an apparent increase in reports during the launch phase of a new device that may reflect heightened awareness rather than true risk elevation.
Code medical events using MedDRA terminology (Preferred Terms, HLTs, SOCs). Classify device problems using IMDRF Annex A through G codes. Write structured clinical narratives summarising the event, patient outcome, and device involvement.
Evaluate the returned device or available lot/batch data. Identify root cause failure modes such as Material Fragmentation, Software Coding Error, Biocompatibility Reaction, Mechanical Fatigue, or Sterilisation Breach. Document findings for inclusion in the MIR.
Format the completed report according to the target authority: eMDR format for the FDA, MIR XML for the EU. Transmit to the relevant health authorities within the applicable regulatory timeline.
Key calendar-day deadlines under EU MDR and FDA 21 CFR 803.
Layered view of submission formats across major regulatory jurisdictions.
Mandatory electronic submission via the FDA eMDR gateway for manufacturers. Uses structured XML based on the HL7 ICSR standard adapted for device reporting.
Currently submitted via national competent authority portals using the MIR form. Full electronic submission through the EUDAMED vigilance module is planned for future deployment.
Manufacturers must provide all information that is reasonably known to them at the time of reporting, including data from complaints, investigations, and post-market surveillance. Follow-up reports are required as new information becomes available.
The MIR is the fundamental unit of device vigilance data. Unlike pharmaceutical ICSRs, the MIR must capture both the clinical outcome (patient injury) and the technical outcome (device failure mode), requiring coordinated input from both medical and engineering teams.