Medical Device Post-Market Surveillance Plan Template
A post-market surveillance plan describes how you will actively gather and assess real-world data on a device after release. This template gives you the standard sections to adapt for your product.
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Medical Device Post-Market Surveillance Plan Template
Post-Market Surveillance Plan
Manufacturer: Acme Medical Devices Inc. Device: Infusion set family IS-200 Class: Class IIa Plan No: PMS-0007 Date: 2026-10-20
1. Purpose and Scope
This plan describes how Acme Medical Devices Inc. proactively collects and analyses data on the quality, performance and safety of Infusion set family IS-200 throughout its lifetime.
2. Data Sources
Complaints, vigilance reports, service records, literature search, registries, social media, customer surveys, PMCF data
3. Analysis Methods
Complaint rate per 10,000 units by failure mode, statistical trending with control limits, comparison to risk file occurrence estimates
4. Triggers and Actions
Trend trigger: Rate above upper control limit for two consecutive months, or any serious injury
When a trigger is met the plan owner opens an investigation, reviews the risk management file, and decides on CAPA, field action or vigilance reporting.
5. Review and Reporting
Review cadence: Quarterly Owner: Head of Regulatory Affairs
Results feed the risk management file, clinical evaluation and the periodic report appropriate to the device class.
Responsibilities
| Activity | Owner | Frequency |
|---|---|---|
| Complaint trending | ||
| Literature search | ||
| PMCF activities | ||
| Risk file update |
Approvals
Starting point, not legal or regulatory advice. EU MDR Articles 83 to 86 and Annex III set the expected content for the EU, and other markets have their own requirements. Align this with your QMS procedure.
Want complaint trending automated?
Optional review of pulling service and complaint data into trend reports.
Optional. The tool and every export work without this. No spam.
How to use the template
Name the device family and class, list every data source you will use, and state how you will analyse it. The trigger field is the part reviewers read closely: it says in advance what level of signal causes an investigation. Choose a review cadence that matches the class and risk. Export to PDF or Word and add it to the technical documentation.
What the regulation expects
Under EU MDR Article 84 and Annex III, the PMS plan is part of the technical documentation and should cover proactive and systematic data collection, suitable indicators and thresholds, methods for complaint investigation, trend reporting tools, and PMCF where applicable. Class IIa devices produce a PMS report, while Class IIb and III produce a PSUR. The FDA expects complaint files and medical device reporting under 21 CFR 803 and 820.198.
- Proactive, not just reactive complaint handling
- Defined thresholds for action
- Link to risk management and clinical evaluation
- PMCF plan where clinical data is needed
Common mistakes
Plans often list sources that are never actually searched, such as registries or literature. Others lack numeric triggers, so no one can say when a trend became a signal. Keep the plan honest about what you will do, connect it to the risk file, and keep evidence that each source was reviewed on schedule.
Frequently Asked Questions
Is a PMS plan required outside the EU?
Other markets expect similar activity under different names, such as complaint handling, MDR reporting and vigilance. A single global plan can satisfy several if mapped to each requirement.
What is the difference between PMS and PMCF?
PMS covers all post-market data collection. PMCF is the specific, planned clinical follow-up that generates clinical data on a CE-marked device to confirm safety and performance.
Do I need one plan per device?
You may cover a family if the devices share design, risks and data sources, but justify the grouping in the plan.
How often is the plan updated?
Whenever findings, regulation or the device change, and at least in line with your periodic review, usually annually.
If complaint and service data sit in your ERP, Netray can help set up automated trend reports. Ask for a short review.
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