Post-Market Surveillance (PMS) Plan Template – MDR
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
EU MDR Articles 83-84 · Annex III §1.1
Post-Market Surveillance (PMS) Plan Template — EU MDR
The systematic surveillance system Annex III requires, with vigilance reportability, FSCA and trend reporting already structured against the articles that govern them.
Surveillance is reactive because the plan never defined proactive
Annex III Section 1.1 expects a PMS Plan that combines proactive data collection with reactive handling of complaints and incidents. A plan built around complaint intake alone satisfies the reactive half and leaves the proactive indicators — trend thresholds, quantitative monitoring — undefined, which means the system only responds after something has already gone wrong.
A plan that works sets both halves out explicitly, with the vigilance decision logic for reportability under Article 87 and the trend reporting thresholds of Article 88 built in from the start.
None of this is difficult. It is the consequence of building surveillance around complaints instead of around a system.
- Word .docx
- Fully editable
- README included
- Instant download
- All device classes
Scope
What the template covers
The complete PMS system Annex III Section 1.1 requires, cross-referenced to the vigilance articles that govern reporting.
01
Compliance matrix and data inputs
An Annex III Section 1.1 compliance matrix, and proactive and reactive PMS data inputs covering the full surveillance system.
02
Indicators and trend analysis
Quantitative indicators and trend analysis methods for monitoring the device once it is on the market.
03
Vigilance and corrective action
Reportability decisions under Article 87 with timelines, Field Safety Corrective Actions under Article 89, and Trend Reporting under Article 88.
Contents
What the document contains
Audience
Who the template is for
- Regulatory affairs and quality managers setting up post-market surveillance
- Manufacturers whose current PMS plan is reactive-only
- Consultants preparing the surveillance system for a Notified Body review
The template assumes you know your device’s classification and post-market data sources. It does not teach Annex III: it gives you the plan structure, ready to complete with your own indicators and thresholds.
What is included
What you get when you buy
- 1 Microsoft Word .docx file, fully editable
- A slim README with usage instructions
- Delivered as a small ZIP, instant download after purchase
Questions
Before you buy
Does this cover vigilance reporting timelines?
Yes, the reportability decision logic under Article 87 with its timelines, and the trend reporting thresholds of Article 88.
Is this the same as the PSUR?
No. This plan defines the surveillance system; the PSUR reports the data that system collects, on a periodic basis under Article 86.
Is this the whole clinical file?
No. This is one of eight coordinated documents. It sets up the system the PSUR and PMCF documents then feed from.
Can I buy the full kit instead?
Yes. This template is one of eight in the EU MDR Clinical Documentation Kit, priced at €399 against €552 buying all eight separately.
What software do I need?
Microsoft Word, or a compatible alternative that opens .docx files without reflowing tables.
Is this a one-off purchase?
Yes. The licence is for single-organisation use and the file is yours to keep.
Need the full clinical lifecycle?
This template is one of eight in the coordinated kit.
The EU MDR Clinical Documentation Kit ships this plan alongside the CEP, CER, CDP, PSUR, PMCF documents and the SSCP. €399 against €552 buying the eight separately.
Post-Market Surveillance (PMS) Plan Template — EU MDR
One Word document, proactive and reactive surveillance in one system.
€69.00
Related products
