What Is External Post-Market Surveillance (PMS) and Why Does It Matter?

The Short Answer

External post-market surveillance (PMS) means systematically monitoring publicly available regulatory databases - recalls, enforcement actions, approvals, clearances, and device listings - for events relevant to your medical device or similar devices on the market.

What the Standards Say

ISO 14971 (Risk Management)

ISO 14971:2019, Clause 10.2 requires manufacturers to collect and review relevant production and post-production information including:

Previously unrecognized hazards or hazardous situations
Changes in risk estimation for previously identified hazards
Regulatory actions taken by authorities on similar devices

External PMS is how you systematically capture this information. Without it, you are relying on ad hoc awareness rather than a documented, repeatable process.

EU MDR Article 83 - Post-Market Surveillance System

The EU Medical Device Regulation (2017/745) Article 83 requires a PMS system that shall be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime.

This includes monitoring incidents reported by other manufacturers, FSCA (Field Safety Corrective Actions), and trend reporting from relevant databases.

FDA Post-Market Surveillance (21 CFR 822)

FDA requires certain device manufacturers to conduct post-market surveillance studies and to monitor the MAUDE database, recall databases, and enforcement actions for signals relevant to their devices.

What Auditors Look For

When an auditor reviews your PMS system, they are checking three things:

Proof of collection: Did you search the relevant databases? What sources did you cover? What date ranges?
Proof of evaluation: Did a qualified person review each signal and make a documented decision?
Proof of coverage: Can you demonstrate your search methodology was comprehensive and repeatable?

An evidence pack with 3-timestamp traceability (Published, Captured, Reviewed) provides all three proofs in a single document.

How TrueMedDevice Helps

TrueMedDevice automates the external PMS workflow:

7 official sources - FDA (510(k), PMA, recalls, enforcement) + Health Canada (recalls, MDALL, MDL)
548,000+ records ingested and indexed, updated daily
Device-specific matching - describe your device once, get matched signals scored by relevance
Human review workflow - your RA/QA team makes the final call on every signal
Audit-ready export - evidence pack with timestamps, source links, content hashes, and coverage statement

Try it free: generate a mini evidence pack for your device in under 3 minutes.