What is Postmarket Surveillance (PMS)?
Postmarket surveillance (PMS) refers to all activities carried out by manufacturers to monitor the performance, safety, and effectiveness of a medical device after it has been placed on the market. It includes collecting and analyzing data related to complaints, adverse events, product failures, and clinical performance in real-world use. PMS is a critical pillar of medical device regulation, ensuring that products remain safe and effective throughout their lifecycle.
PMS Regulation in the US and EU
While both the U.S. FDA and the European Union recognize the importance of PMS, their regulatory approaches differ significantly in structure, terminology, and execution.
The FDA integrates PMS activities across various quality system elements such as complaint handling, MDR reporting, and CAPA, without referring to it as a unified system.
In contrast, the EU Medical Device Regulation (MDR) treats PMS as a formal, proactive, and lifecycle-spanning obligation, complete with dedicated plans and periodic reporting requirements. This post explores the similarities and key differences between FDA and EU approaches to PMS, helping manufacturers navigate compliance in both regulatory environments.
FDA (21 CFR Part 820 – QSR): PMS by Function, Not by Name
While the FDA doesn’t formally call it “postmarket surveillance” (except in certain contexts under Section 522 for Class II and III devices), key elements of PMS are embedded throughout the Quality System Regulation (QSR):
| 21 CFR Reference | Subject | Requirement |
|---|---|---|
| 820.198 | Complaint Handling | Requires manufacturers to establish procedures for receiving, reviewing, and evaluating complaints. |
| Part 803 | Medical Device Reporting (MDR) | Requires reporting of certain adverse events and device malfunctions to the FDA. |
| Part 806 | Corrections and Removals (Recalls) | Mandates reporting certain field actions and maintaining records of others. |
| 820.90 (general) | Nonconforming Product | Includes analysis and response to postmarket issues affecting conformance. |
| 820.100 | CAPA (Corrective and Preventive Action) | Ensures investigation and response to quality issues identified postmarket. |
| 820.200 | Servicing & Repairs | Can generate postmarket data that must be reviewed for quality issues. |
Overview of Changes
QMSR Info Request Form
Definitions
Affected Regulations and Standards
Assembling the Puzzle
Implementation Strategies
Small Manufacturers
EU MDR (Regulation (EU) 2017/745): PMS as a Central Requirement
The EU MDR takes a more structured and proactive approach to PMS, treating it as a continuous and lifecycle-integrated obligation:
MDR Article/Annex Subject PMS Function
Article 83 PMS System Requires all manufacturers to establish, implement, and maintain a PMS system.
Annex III, Section 1.1 PMS Plan Part of technical documentation; defines how data will be collected and used.
Article 85 PMS Report (PMSR) Required for Class I devices; summarizes results and conclusions of PMS.
Article 86 (general) Periodic Safety Update Report (PSUR) Required for Class IIa, IIb, III; includes benefit-risk conclusions, sales data, usage population, etc.
Article 88 Trend Reporting Requires reporting of statistically significant increases in non-serious incidents or expected side effects.
Articles 87–92 Vigilance Reporting Mandates reporting of serious incidents, FSCA, and periodic updates to Notified Bodies and Competent Authorities.
Annex XIV Part B Premarket Clinical Follow-up (PMCF) A proactive subset of PMS, particularly for higher-risk or novel devices.