--- title: "Medical Device Vigilance, Definition | MedTech Terms" description: "Reporting and management of serious incidents and field safety corrective actions. Plain-English Post-Market definition for MedTech teams, with examples and rel" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/vigilance#term", "name": "Medical Device Vigilance", "description": "Vigilance is the regulatory process by which manufacturers report serious incidents and field safety corrective actions involving CE-marked devices to the relevant Competent Authorities. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Post-Market](/terms?cat=Post-Market) 6. / 7. Medical Device Vigilance [All terms](/terms) Post-Market [Post-Market & Safety](/ecosystems/post-market-safety)[Startup Lifecycle](/ecosystems/startup-lifecycle) # Medical Device Vigilance Reporting and management of serious incidents and field safety corrective actions. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Vigilance is the regulatory process by which manufacturers report serious incidents and field safety corrective actions involving CE-marked devices to the relevant Competent Authorities. Equivalent obligations apply under FDA's Medical Device Reporting ( [MDR](/terms/mdr-reporting)) regulation in 21 CFR Part 803. ## What this means in practice Vigilance feeds back into [PMS](/terms/post-market-surveillance), risk management, and [CAPA](/terms/capa). Timeliness of reporting is closely scrutinized by regulators. ## Use cases 1 scenario 1 ### Serious incident with a surgical robot Vigilance officer A patient injury linked to a robot's instrument is reported to the manufacturer. Within 10 days, an initial vigilance report is filed in [EUDAMED](/terms/eudamed); a [Field Safety Corrective Action](/terms/fsca) follows with a software update and FSN to all users. Outcome Competent authorities accept the [FSCA](/terms/fsca); further incidents are prevented and the trend closes out in subsequent PSURs. ## Cross-references ### See also Closely related context worth reading. - [ Medical Device Reporting (FDA)(MDR) ](/terms/mdr-reporting) ## 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 Medical Device Reporting (FDA)(MDR) FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions. ](/terms/mdr-reporting)[ Post-Market Post-Market Surveillance(PMS) Activities to monitor device safety and performance after market release. ](/terms/post-market-surveillance) ### EU MDR Essentials · From this learning path [ Post-Market Periodic Safety Update Report(PSUR) Periodic EU MDR/IVDR report summarizing post-market surveillance findings. Adjacent lesson ](/terms/psur?from=eu-mdr-essentials)[ Regulatory CE Mark Mandatory European conformity mark for medical devices placed on the EU market. ](/terms/ce-mark?from=eu-mdr-essentials)[ Regulatory EU In Vitro Diagnostic Regulation(IVDR) Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. ](/terms/ivdr?from=eu-mdr-essentials)[ Regulatory EUDAMED European Database on Medical Devices. ](/terms/eudamed?from=eu-mdr-essentials) ### Post-Market Mastery · From this learning path [ Post-Market Medical Device Recall Removal or correction of a marketed device that violates FDA law. ](/terms/recall?from=post-market-mastery)[ Quality & Risk Complaint Handling Process for receiving, evaluating, and responding to device complaints. ](/terms/complaint-handling?from=post-market-mastery)[ Quality & Risk Corrective and Preventive Action(CAPA) Systematic process to investigate and resolve quality issues and prevent recurrence. ](/terms/capa?from=post-market-mastery)[ Clinical & Trials Real-World Evidence(RWE) Clinical evidence regarding the usage and potential benefits or risks of a device derived from real-world data. ](/terms/real-world-evidence?from=post-market-mastery) ### IVDR Essentials · From this learning path [ Regulatory Notified Body(NB) EU-designated organization that assesses conformity of medical devices under MDR and IVDR. ](/terms/notified-body?from=ivdr-essentials)[ Post-Market Post-Market Performance Follow-up(PMPF) The IVDR counterpart of PMCF: ongoing collection and analysis of performance data after CE certification. ](/terms/pmpf?from=ivdr-essentials)[ Post-Market PSUR (IVDR Specific) Periodic Safety Update Report obligations for IVDs under EU IVDR Article 81. ](/terms/psur-ivdr?from=ivdr-essentials)[ Manufacturing UDI-DI vs. UDI-PI Static device identifier (DI) vs. dynamic production identifier (PI) within a UDI. Adjacent lesson ](/terms/udi-di-pi?from=ivdr-essentials) Cited by Where this term appears across MedTech Terms. Learning paths (3) - [EU MDR Essentials](/paths/eu-mdr-essentials)Lesson 8 of 9 - [Post-Market Mastery](/paths/post-market-mastery)Lesson 3 of 9 - [IVDR Essentials](/paths/ivdr-essentials)Lesson 12 of 13 Ecosystems (2) - [Post-Market & Safety](/ecosystems/post-market-safety) - [Startup Lifecycle](/ecosystems/startup-lifecycle) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 European Commission· 2 FDA· 1 1. [1 MDCG Vigilance Guidance Verified European Commission · 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 Sources 3 Use cases 1 Updated 5/5/2026 [Compare with another term](/compare?a=vigilance) Learn in 60 seconds Card Lesson Quiz Reporting and management of serious incidents and field safety corrective actions. - · Vigilance feeds back into PMS, risk management, and CAPA. - · Timeliness of reporting is closely scrutinized by regulators. - · Equivalent obligations apply under FDA's Medical Device Reporting (MDR) regulation in 21 CFR Part 803. Remember this Reporting and management of serious incidents and field safety corrective actions. Related terms - [Post-Market Surveillance(PMS) ](/terms/post-market-surveillance) - [Medical Device Reporting (FDA)(MDR) ](/terms/mdr-reporting) - [Field Safety Corrective Action(FSCA) ](/terms/fsca) You may also need Auto-suggested from Post-Market and shared keywords. - [Field Action vs Recall ](/terms/field-action-vs-recall) - [Removal vs Correction (21 CFR 806) ](/terms/removal-vs-correction) - [Manufacturer Incident Report(MIR) ](/terms/mir) - [Post-Market Clinical Follow-up(PMCF) ](/terms/pmcf) - [Post-Market Performance Follow-up(PMPF) ](/terms/pmpf) - [AI Act Serious Incident Reporting ](/terms/ai-act-serious-incident-reporting) [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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