Manufacturer Incident Report
Standardized EU vigilance report submitted to competent authorities via EUDAMED.
Definition
MIRs use a harmonized template (initial, follow-up, final) capturing serious incident details, root cause, CAPA, and FSCA linkage. EUDAMED is the central submission channel. The MIR form is maintained by the European Commission and MDCG and is used for initial, follow-up, combined and final reports, including IMDRF adverse event terminology codes for the problem, investigation and component. Until the EUDAMED vigilance module is mandatory, reports are sent to national competent authorities, usually by email using the MIR XML or PDF form.What this means in practice
MIRs replaced legacy national-format reports; alignment with FDA MDR data fields helps run a single global vigilance database.Examples
- A manufacturer submits an initial MIR within two days of learning that an implanted cardiac device failed, leading to a patient fatality.
- A manufacturer submits a follow-up MIR to EUDAMED after identifying a software bug as the root cause of a series of device malfunctions previously reported.
- A manufacturer submits a final MIR confirming the implementation of a field safety corrective action to address a design flaw, including details on the affected devices and the resolution provided.
- •A common pitfall is failing to submit an MIR within the mandated timelines, which are typically defined by the severity of the incident and can range from immediately to 15 days.
- •Another mistake is submitting incomplete MIRs, leading to requests for additional information and delays in incident closure.
- •Manufacturers sometimes neglect to properly investigate the root cause of an incident before submitting the MIR, resulting in inadequate corrective and preventive actions (CAPAs).
Frequently asked questions
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsAction taken to reduce a risk of serious deterioration in health associated with a device.
Reporting and management of serious incidents and field safety corrective actions.
Obligation to report statistically significant increases in expected non-serious incidents.
More in Post-Market
· Same categoryExpedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm.
Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status.
Communication to users notifying them of a safety issue, corrective action, or important product information.
FDA's mandatory electronic submission system for Medical Device Reports.
Where this term appears across MedTech Terms.
Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1MDCG 2023-3Tier 2 VerifiedMDCGhealth.ec.europa.eu
- 2EUDAMED Public SiteTier 2 VerifiedEuropean Commissionec.europa.eu
- 3FDA MAUDE DatabaseTier 2 VerifiedFDAaccessdata.fda.gov
Inline markers like [1] jump to the matching reference above.