PMS Requirements by Class
Overview
Post-market surveillance (PMS) is the systematic collection and analysis of real-world data about a medical device after it has been placed on the Australian market. PMS is an ongoing obligation for all manufacturers, not a one-off exercise at ARTG inclusion. The TGA expects manufacturers to have a structured PMS system in place proportionate to the risk and novelty of the device. PMS data feeds back into the clinical evaluation, risk management, and adverse event reporting processes — it is the mechanism by which manufacturers detect and respond to safety signals emerging from real-world use.
What PMS Must Cover
A compliant PMS system must systematically collect, review, and act on data from sources including:
- Adverse event reports and complaints received from healthcare facilities, clinicians, and users
- Feedback from the distribution network — distributors and importers who may receive complaints before the manufacturer
- Published literature on the device type, materials, or clinical area — including competitor device data where relevant to the manufacturer's device
- Overseas regulatory databases — FDA MAUDE, EU EUDAMED, MHRA Yellow Card, TGA DAEN
- Registry data — device registries (e.g., the Australian Orthopaedic Association National Joint Replacement Registry for implants)
- Post-market clinical follow-up (PMCF) data — for higher-risk devices where pre-market clinical evidence was insufficient to address all questions
- Technical complaints — reports of device malfunction or performance issues that did not result in patient harm
All PMS data must be analysed and the conclusions must be fed back into the device's risk management file and clinical evaluation report. The PMS system must be documented and periodically reviewed.
PMS Requirements by Device Class
The intensity of PMS obligations scales with device class:
| Class | PMS Requirements |
|---|---|
| Class I | Basic PMS — complaint handling, adverse event monitoring. No mandatory formal PMS plan required but good practice to have one. |
| Class IIa | Systematic PMS plan required. Review of complaints, literature, adverse events. Periodic review of clinical evidence. |
| Class IIb | Comprehensive PMS plan. More frequent review cycles. PMCF may be required where pre-market evidence gaps exist. |
| Class III | Extensive PMS. Annual review of clinical evidence and PMS data. PMCF typically required. Annual reporting to TGA. |
| AIMD (now Class III) | As Class III — annual reporting required. |
| IVD Class 1–2 | Performance monitoring, complaint handling, analytical performance trending. |
| IVD Class 3–4 | Comprehensive PMS including clinical performance monitoring. Annual reporting for Class 4. |
PMS Documents
Manufacturers should maintain the following PMS documentation:
PMS Plan — describes the methodology for collecting and analysing PMS data, including data sources, review frequency, responsibilities, and escalation procedures.
PMS Report (PMSR) or Periodic Safety Update Report (PSUR) — the periodic summary of PMS data and conclusions. For lower-risk devices, a PMSR is typically sufficient. For higher-risk devices (Class IIb implantable, Class III), a PSUR is required, submitted to the TGA as part of annual reporting obligations.
PMCF Plan and Report — for devices where post-market clinical follow-up is indicated, a specific PMCF plan and periodic PMCF reports must be maintained.
Relationship Between PMS and Other Obligations
PMS does not exist in isolation — it connects directly to:
- Adverse event reporting: PMS data analysis may trigger the identification of events requiring IRIS reporting
- Risk management: PMS conclusions must update the device risk management file (ISO 14971)
- Clinical evaluation: PMS data must be incorporated into the ongoing clinical evaluation (CER updates)
- ARTG conditions: Failure to maintain adequate PMS is a breach of ARTG conditions of inclusion