--- title: "MIR, Manufacturer Incident Report | MedTech Terms" description: "Standardized EU vigilance report submitted to competent authorities via EUDAMED. Plain-English Post-Market definition for MedTech teams, with examples and relat" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/mir#term", "name": "Manufacturer Incident Report", "alternateName": "MIR", "description": "MIRs use a harmonized template (initial, follow-up, final) capturing serious incident details, root cause, CAPA, and FSCA linkage. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Post-Market](/terms?cat=Post-Market) 6. / 7. Manufacturer Incident Report [All terms](/terms) Post-Market [Post-Market & Safety](/ecosystems/post-market-safety)[Global Markets](/ecosystems/global-markets)MIR # Manufacturer Incident Report Standardized EU vigilance report submitted to competent authorities via EUDAMED. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition MIRs use a harmonized template (initial, follow-up, final) capturing serious incident details, root cause, [CAPA](/terms/capa), and [FSCA](/terms/fsca) linkage. [EUDAMED](/terms/eudamed) is the central submission channel. What the regulation says The EU [MDR](/terms/mdr-reporting) (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](/terms/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](/terms/mdr-reporting) 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 What constitutes a 'serious incident' requiring an MIR? 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. Where are MIRs submitted and processed? How often should follow-up MIRs be submitted? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Post-Market Field Safety Corrective Action(FSCA) Action taken to reduce a risk of serious deterioration in health associated with a device. ](/terms/fsca)[ Post-Market Trend Reporting (MDR/MIR) Obligation to report statistically significant increases in expected non-serious incidents. ](/terms/trend-reporting) ### More in Post-Market · Same category [ Post-Market 5-Day Report Expedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm. ](/terms/five-day-report)[ Post-Market Annual Report (PMA) Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status. ](/terms/annual-report-pma)[ Post-Market Customer Notification Letter Communication to users notifying them of a safety issue, corrective action, or important product information. ](/terms/customer-notification)[ Post-Market Electronic Medical Device Reporting(eMDR) FDA's mandatory electronic submission system for Medical Device Reports. ](/terms/emdr) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Post-Market & Safety](/ecosystems/post-market-safety) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 MDCG· 1 European Commission· 1 FDA· 1 1. [1 MDCG 2023-3 Verified MDCG · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en) 2. [2 EUDAMED Public Site Verified European Commission · ec.europa.eu ](https://ec.europa.eu/tools/eudamed/) 3. [3 FDA MAUDE Database Verified FDA · accessdata.fda.gov ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Post-market cybersecurity surveillance? We help MedTech teams stand up vulnerability monitoring, coordinated disclosure, and post-market reporting workflows. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Post-Market Acronym MIR Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=mir) Learn in 60 seconds Card Lesson Quiz Standardized EU vigilance report submitted to competent authorities via EUDAMED. - · MIRs replaced legacy national-format reports; alignment with FDA MDR data fields helps run a single global vigilance database. - · EUDAMED is the central submission channel. Remember this Watch out: 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. Related terms - [Trend Reporting (MDR/MIR) ](/terms/trend-reporting) - [Field Safety Corrective Action(FSCA) ](/terms/fsca) You may also need Auto-suggested from Post-Market and shared keywords. - [Medical Device Vigilance ](/terms/vigilance) - [Authorized Representative (EU)(EC REP) ](/terms/ec-rep) - [Performance Study Application (IVDR) ](/terms/ivdr-performance-study-application) - [Electronic Medical Device Reporting(eMDR) ](/terms/emdr) - [AI Act Serious Incident Reporting ](/terms/ai-act-serious-incident-reporting) - [5-Day Report ](/terms/five-day-report) [All Post-Market terms](/terms?cat=Post-Market) From the Blue Goat network Related resources and services on this topic. - [ Code Blue Real medical device cybersecurity incidents and their lessons. ](https://codebluechart.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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