PMCF Evaluation Report Template – MDR
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
Annex XIV Part B
PMCF Evaluation Report Template — EU MDR
The document that reports what the PMCF Plan’s activities actually found, against the thresholds it set, and what that means for the CER.
The report lists activities, not what they showed
A PMCF Evaluation Report that lists what was done — literature searched, surveys sent, registries queried — without comparing results to the plan’s acceptance thresholds tells a reviewer nothing about whether the device’s benefit-risk profile still holds. Annex XIV Part B expects a comparison against a stated threshold, not an activity log.
A report that works sets executed activities against what was planned, analyses results by activity source, and states explicitly what the findings mean for the CER’s benefit-risk conclusion and the current state of the art.
None of this is difficult. It is the difference between a log and an evaluation.
- Word .docx
- Fully editable
- README included
- Instant download
- All device classes
Scope
What the template covers
Every element Annex XIV Part B requires of the evaluation report, from what was executed to what it means for the benefit-risk conclusion.
01
Executive summary and activities executed
An executive summary of activities executed, key findings, impact on benefit-risk and actions triggered, plus activities executed against what was planned.
02
Results by activity
Findings broken out by source: literature, vigilance, complaints, FSCAs, PMCF study, surveys, registries and real-world data.
03
Integrated analysis and impact
An integrated analysis against acceptance thresholds, an update to the state of the art, and the impact on the benefit-risk ratio and on the CER.
Contents
What the document contains
Audience
Who the template is for
- Regulatory affairs managers reporting on completed PMCF activities
- Manufacturers whose PMCF reporting lists activities without an evaluation
- Consultants updating a CER on the basis of post-market clinical data
The template assumes a PMCF Plan already exists and its activities have produced results to report. It does not teach Annex XIV Part B: it gives you the report structure, ready to complete with your own findings.
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
Do I need the PMCF Plan first?
You need its acceptance thresholds to complete the integrated analysis section. The EU MDR Clinical Documentation Kit ships both, built to reference each other.
Does this feed back into the CER?
Yes, the report includes a section stating the impact on the benefit-risk ratio and on the CER specifically.
Is this the whole clinical file?
No. This is one of eight coordinated documents. It closes the loop the PMCF Plan opens.
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 PMCF Plan, CEP, CER, CDP, PMS Plan, PSUR and the SSCP. €399 against €552 buying the eight separately.
PMCF Evaluation Report Template — EU MDR
One Word document, results checked against the plan’s own thresholds.
€69.00
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