Periodic Safety Update Report (PSUR) Template – MDR
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
EU MDR Article 86
Periodic Safety Update Report (PSUR) Template — EU MDR
The periodic report that shows the benefit-risk profile as it evolves, structured so the conclusion follows from production volume, usage and incident data rather than restating the CER.
The PSUR repeats the last one instead of updating it
Article 86 asks for a report on how the benefit-risk profile has evolved over a defined period, closing the loop from the previous PSUR’s actions. Written as a fresh document each time, a PSUR loses that continuity: the status of prior actions goes unreported, and the risk-benefit conclusion reads the same as last cycle’s regardless of what the post-market data actually showed.
A PSUR that works opens with the status of the previous report’s actions, sets production volume and usage data against that baseline, and only then draws its conclusion.
None of this is difficult. It is the consequence of writing each PSUR as if it were the first one.
- Word .docx
- Fully editable
- README included
- Instant download
- All device classes
Scope
What the template covers
Every element Article 86 requires, structured to carry continuity from one reporting period to the next.
01
Executive summary and continuity
An executive summary covering the status of previous actions, the data collection period and the benefit-risk conclusion, plus devices covered and grouping justification.
02
Production and usage data
Production volume, population analysis and usage frequency, set against the previous reporting period.
03
Risk-benefit and vigilance
A risk-benefit analysis based on post-market data, plus serious incidents and FSCAs under Article 87 and trend reporting under Article 88.
Contents
What the document contains
Audience
Who the template is for
- Regulatory affairs and quality managers producing periodic safety reports
- Manufacturers whose PSUR does not carry forward the previous period’s actions
- Consultants managing multi-device PSUR grouping
The template assumes a PMS Plan and vigilance data are already in place. It does not teach Article 86: it gives you a report structured for continuity, ready to complete with your own period’s data.
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
Can I group several devices in one PSUR?
Yes, the template includes a devices-covered and grouping-justification section for that case.
Does this connect to my PMS Plan?
It draws on the same proactive and reactive data the PMS Plan defines. The EU MDR Clinical Documentation Kit ships both, built to work together.
Is this the whole clinical file?
No. This is one of eight coordinated documents. It reports the data the PMS system collects, on the periodic cycle Article 86 requires.
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 report alongside the CEP, CER, CDP, PMS Plan, PMCF documents and the SSCP. €399 against €552 buying the eight separately.
Periodic Safety Update Report (PSUR) Template — EU MDR
One Word document, continuity from one reporting period to the next.
€69.00
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