Post-Market Surveillance (PMS)

What is post-market surveillance? Post-market surveillance (PMS) is the set of activities a medical device manufacturer uses to collect and analyze data on a device’s safety and performance after it reaches the market, and to act on what that data shows. PMS draws on complaints, adverse event reports, service records, published literature, registries, and other real-world evidence. The results feed risk management, CAPA, and labeling updates. Regulators in every major market require it, including FDA in the United States, the EU under the MDR and IVDR, and the MHRA in Great Britain.

For step-by-step FDA, EU, and UK requirements, PMS plan structure, and data sources, read our complete guide to post-market surveillance for medical devices.

To comply with FDA’s Quality Management System Regulation (QMSR), which has incorporated ISO 13485:2016 by reference since February 2, 2026, medical device manufacturers must run post-market surveillance activities to monitor the safety and effectiveness of the medical devices that they sell. Since medical devices are typically approved for sale based on clinical trials that involve fairly few people, post-market surveillance is a necessity because it often reveals more about the safety and effectiveness of a medical device that couldn't be learned from a clinical trial alone.

In the United States, the FDA oversees the post-market surveillance activities of medical device companies, including monitoring incidents of adverse reactions to medical devices through its reporting system called MedWatch.

FREE DOWNLOAD: Click here to download your PDF copy of the most common sources of post-market surveillance data.

Post-market surveillance requirements in the United States

Wherever you intend to sell your medical devices, you must comply with the applicable requirements for post-market surveillance.

In the United States, manufacturers must submit Medical Device Reports electronically (eMDR) under 21 CFR Part 803, while health professionals and patients can report problems voluntarily through MedWatch. FDA can also order a manufacturer to run a postmarket surveillance study under Section 522, or require a post-approval study as a condition of PMA approval.

FDA may order Section 522 surveillance for a class II or III device that meets any of these criteria:

1. Its failure would be reasonably likely to have serious adverse health consequences.
2. It is expected to have significant use in pediatric populations.
3. It is intended to be implanted in the body for more than one year.
4. It is intended to be a life-sustaining or life-supporting device used outside a device user facility.

Class I medical devices are normally exempt from post-market surveillance orders, as these devices are the lowest risk class. The manufacturer must submit its surveillance plan within 30 days of receiving the order and begin surveillance no later than 15 months after the order is issued (21 CFR Part 822).

What Are The PMS Requirements For The European Market?

Unlike in the United States, where PMS activities are only required for higher-risk devices that typically require premarket approval, all medical device manufacturers that sell in the European Union are required to demonstrate that they have conducted post-market clinical follow-up (PMCF) or provide a justification for why this was not done.

PMCF is most commonly required in cases where the medical device uses novel medical technology, carries a high product-related risk, is in use with high-risk populations (geriatric or pediatric applications), or to verify the safety and performance of the device when exposed to a more varied population of users than in the initial clinical trial.

To comply with EU MDR and IVDR, you will need to consider Periodic Safety Update Reporting (PSUR).

FREE DOWNLOAD: Click here to download your PDF copy of the most common sources of post-market surveillance data.

How a QMS supports post-market surveillance

Post-market surveillance is an area of growing relevance in the international medical device market. Post-market expectations keep tightening. FDA finalized its current Section 522 guidance in October 2022, the EU MDR’s post-market requirements (Articles 83 to 86) apply to every device on the EU market, and new post-market surveillance regulations for Great Britain took effect on June 16, 2025.

Greenlight Guru's quality management software helps medical device manufacturers streamline and automate their PMS processes. PMS generates a lot of documents: the surveillance plan, incident reports, customer feedback, CAPA records, surveys, service reports, literature reviews, implant registry data, and more.

Greenlight Guru maintains the organization, security, and integrity of documents throughout your PMS studies, making it easier than ever to comply with legal requirements wherever you sell your devices.