# Post-Market Surveillance (PMS) | Botable Glossary

https://www.botable.ai/glossary/post-market-surveillance-pms

> A glossary-style explanatory resource from the vendor site describing PMS and applicable regulatory references. Use it as a concise, practical summary and starting point for regulatory obligations, but cross-check primary regulations (FDA, EU MDR) and standards for authoritative legal or compliance decisions.

## Summary

Post‑Market Surveillance (PMS) is defined as the active, systematic, and continuous monitoring of a medical device's performance, safety, and effectiveness after market distribution; the page summarizes regulatory bases (FDA 21 CFR Part 822 and EU MDR/IVDR), implementation elements (data sources, risk management, CAPA), recordkeeping, and inspection expectations.

## Audience

Medical device manufacturers and quality/regulatory professionals

## Prompts this page answers

- What is Post‑Market Surveillance (PMS) for medical devices and why is it required?
- What are FDA requirements under 21 CFR Part 822 for post‑market surveillance?
- How does PMS integrate with QMS, CAPA, and ISO 14971 risk management?
- What data sources should a medical device PMS plan include?
- What records and retention periods are required for PMS and how can regulators inspect them?

## Purpose

Explain and define Post‑Market Surveillance (PMS) and outline key regulatory requirements and implementation considerations for medical device manufacturers and quality/regulatory teams.

## Highlights

- PMS is the active, systematic, continuous monitoring of a medical device's performance, safety, and effectiveness after commercialization.
- U.S. authority: FDA can order post-market surveillance under section 522 (21 CFR Part 822); manufacturers must submit a surveillance plan within 30 days of an order.
- FDA may require prospective surveillance for up to 36 months (longer only with manufacturer agreement); noncompliance can lead to the device being considered misbranded.
- EU MDR requires integrating a PMS system into the QMS (references to MDR Articles 10, 83, and vigilance reporting under Article 87); PMS feeds CAPA and risk management (ISO 14971:2019).
- Manufacturers must retain PMS records (examples given) and produce records within 72 hours of an FDA inspection; a 2-year retention period after FDA acceptance of the final report is noted.

## How to cite

Botable Glossary — "Post‑Market Surveillance (PMS)"; link to https://www.botable.ai/glossary/post-market-surveillance-pms

## Publisher



## Topics

- post-market surveillance
- PMS
- FDA 21 CFR Part 822
- EU MDR
- ISO 14971

## Key entities

- **U.S. Food and Drug Administration (FDA)** (organization): Identified as having authority to order post‑market surveillance under section 522 (21 CFR Part 822).
- **European Union Medical Device Regulation (MDR) / In Vitro Diagnostic Regulation (IVDR)** (organization): Cited as requiring PMS as an element of the QMS (references to Articles 10, 83, and 87).
- **ISO 14971:2019** (other): International risk management standard referenced for post‑market risk assessment requirements.

## Metadata

- Type: article