All terms
Manufacturer Incident Report
Standardized EU vigilance report submitted to competent authorities via EUDAMED.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
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. What the regulation says
The EU MDR (Regulation 2017/745) specifies the requirements for manufacturers to report serious incidents through a Manufacturer Incident Report, as detailed in Article 87. The content and format of these reports are further elaborated in implementing acts published by the European Commission, ensuring a harmonized approach across member states. These reports are integral to post-market surveillance activities, allowing competent authorities to monitor the safety and performance of medical devices.
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.
Common pitfalls
- •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
A serious incident is any malfunction or deterioration in the characteristics or performance of a device, as well as any inadequacy in the information supplied by the manufacturer, which might lead to or has led to the death or serious deterioration in the state of health of a patient, user, or other person.
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5-Day Report
Expedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm.
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Annual Report (PMA)
Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status.
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Customer Notification Letter
Communication to users notifying them of a safety issue, corrective action, or important product information.
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Electronic Medical Device Reporting(eMDR)
FDA's mandatory electronic submission system for Medical Device Reports.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
MDCG·1European Commission·1FDA·1
- 1
MDCG 2023-3VerifiedMDCGhealth.ec.europa.eu
- 2
EUDAMED Public SiteVerifiedEuropean Commissionec.europa.eu
- 3
FDA MAUDE DatabaseVerifiedFDAaccessdata.fda.gov
Inline markers like [1] jump to the matching reference above.