---
title: "Post-Market & Safety - MedTech Ecosystems"
description: "What happens after launch: adverse event reporting (MDR/MIR), recalls, FDA warning letters, periodic safety reports, and the post-market surveillance plans…"
lang: en
json-ld:
---

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Ecosystem 

# Post-Market & Safety

What happens after launch: adverse event reporting (MDR/MIR), recalls, FDA warning letters, periodic safety reports, and the post-market surveillance plans MDR requires.

33 terms

## Regulatory5 

-   [AI Act Serious Incident Reporting ](/terms/ai-act-serious-incident-reporting)
-   [ANVISA(ANVISA) ](/terms/anvisa)
-   [Importer and Distributor Obligations (EU) ](/terms/importer-distributor)
-   [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan)
-   [Special Controls ](/terms/special-controls)

## Quality & Risk1 

-   [Warning Letter ](/terms/warning-letter)

## Clinical & Trials4 

-   [Adverse Event(AE) ](/terms/adverse-event)
-   [IDE Annual Progress Report ](/terms/ide-annual-report)
-   [Serious Adverse Event(SAE) ](/terms/sae)
-   [Unanticipated Adverse Device Effect(UADE) ](/terms/uade)

## Software & AI1 

-   [Model Drift Monitoring ](/terms/drift-monitoring)

## Post-Market22 

-   [5-Day Report ](/terms/five-day-report)
-   [Annual Report (PMA) ](/terms/annual-report-pma)
-   [Customer Notification Letter ](/terms/customer-notification)
-   [Electronic Medical Device Reporting(eMDR) ](/terms/emdr)
-   [FDA Recall Classifications I, II, III ](/terms/recall-classifications)
-   [Field Action vs Recall ](/terms/field-action-vs-recall)
-   [Field Safety Corrective Action(FSCA) ](/terms/fsca)
-   [Global Unique Device Identification Database(GUDID) ](/terms/gudid)
-   [Health Hazard Evaluation(HHE) ](/terms/health-hazard-eval)
-   [Manufacturer Incident Report(MIR) ](/terms/mir)
-   [Medical Device Recall ](/terms/recall)
-   [Medical Device Reporting (FDA)(MDR) ](/terms/mdr-reporting)
-   [Medical Device Vigilance ](/terms/vigilance)
-   [Periodic Safety Update Report(PSUR) ](/terms/psur)
-   [Post-Market Clinical Follow-up(PMCF) ](/terms/pmcf)
-   [Post-Market Performance Follow-up(PMPF) ](/terms/pmpf)
-   [Post-Market Surveillance(PMS) ](/terms/post-market-surveillance)
-   [Post-Market Surveillance Plan ](/terms/pms-plan)
-   [PSUR (IVDR Specific) ](/terms/psur-ivdr)
-   [Removal vs Correction (21 CFR 806) ](/terms/removal-vs-correction)
-   [Section 522 Postmarket Surveillance(Section 522) ](/terms/section-522)
-   [Trend Reporting (MDR/MIR) ](/terms/trend-reporting)

### Other ecosystems

[Regulated Pathways](/ecosystems/regulated-pathways)[AI / ML in Devices](/ecosystems/ai-ml)[Connected & Cyber-Physical Devices](/ecosystems/connected-devices)[Software Lifecycle](/ecosystems/software-lifecycle)[Quality System](/ecosystems/quality-system)[Clinical Evidence](/ecosystems/clinical-evidence)[Global Markets](/ecosystems/global-markets)[Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer)[Startup Lifecycle](/ecosystems/startup-lifecycle)[Strategic Landscape](/ecosystems/strategic-landscape)[Manufacturing & Supply](/ecosystems/manufacturing-supply)

MedTech Terms 

An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices.

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Resources

-   [FDA Medical Devices](https://www.fda.gov/medical-devices)
-   [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj)
-   [IMDRF](https://www.imdrf.org/)
-   [Methodology](/methodology)
-   [Changelog](/changelog)
-   [Editor: Christian Espinosa](/authors/christian-espinosa)
-   [About this site](/about)

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