Post-Market Surveillance (PMS)

What is post-market surveillance?

PMS is the systematic collection, analysis and use of information about a device after it is placed on the market. Inputs can include complaints, service records, registries, literature, user feedback, adverse-event reports and trend data. The manufacturer evaluates those inputs against the device's benefit-risk and risk-management documentation, then records whether labeling, design, clinical evaluation, corrective action or field action needs to change.

What does the EU MDR require?

The EU MDR requires a PMS system proportionate to device risk and a PMS plan within the technical documentation. Class I devices generally have a PMS report, while Class IIa, IIb and III devices have a Periodic Safety Update Report on the cadence specified by Article 86. Post-market clinical follow-up is part of the continuing clinical-evaluation process unless the manufacturer provides an appropriate justification. Vigilance covers the related reporting of serious incidents and field safety corrective actions.

How does U.S. practice compare?

The United States distributes comparable activities across complaint handling and CAPA under the QMSR, mandatory adverse-event reporting under Part 803, corrections and removals, recalls and device-specific tools such as post-approval studies or Section 522 orders. The sources can overlap with an EU PMS system, but the legal definitions, reporting thresholds and required outputs remain jurisdiction-specific.

What does a credible PMS system look like in practice?

It defines data sources, owners, review frequency and escalation thresholds; connects signal evaluation to ISO 14971 risk records; and records the rationale for action or no action. The important evidence is not merely that data were collected, but that the manufacturer evaluated them consistently and updated required outputs. A global process can support the European Union and United States while preserving those market-specific decisions.