PMCF Plan Template – MDR
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
EU MDR Article 61(11) · Annex XIV Part B
PMCF Plan Template — EU MDR
The activity programme for proactively collecting clinical data on the marketed device, with acceptance thresholds set before the data starts arriving.
The threshold gets set after the data arrives
Annex XIV Part B asks for acceptance criteria and action triggers defined in the plan, before literature monitoring, surveys or a PMCF study start producing results. Set afterward, a threshold can always be adjusted to fit whatever the data happened to show, which is exactly what a reviewer is checking for.
A PMCF Plan that works states the objectives, justifies why the chosen methods are proportionate to the device and its risks, and fixes the acceptance criteria and trigger logic before the first data point comes in.
None of this is difficult. It is the consequence of writing the criteria to match the results instead of the other way round.
- 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 plan, from objectives to the trigger logic that acts on the data.
01
Objectives and method justification
Specific objectives of the PMCF, and a methods justification per Annex XIV Part B for why the chosen activities fit the device.
02
Activity programme
Literature monitoring, surveys, registries, real-world data and PMCF clinical studies, set out as a coordinated programme rather than isolated activities.
03
Acceptance criteria and governance
Reference acceptance criteria, threshold triggers and action logic, with roles, responsibilities, timeline and reporting frequency.
Contents
What the document contains
Audience
Who the template is for
- Regulatory affairs managers setting up post-market clinical follow-up
- Manufacturers whose PMCF activities have no defined acceptance criteria
- Consultants scoping a proportionate PMCF programme by device risk class
The template assumes you know your device’s classification and the outstanding clinical questions from the CER or CDP. It does not teach Annex XIV Part B: it gives you the plan structure, ready to complete with your own activity programme.
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
Is a PMCF Plan mandatory for every device?
PMCF is required unless duly justified as not applicable, per Annex XIV Part B. Where PMCF is not applicable, the justification itself has to be documented.
Does this connect to the CDP?
It is normally built to address the residual uncertainties the Clinical Development Plan identifies. The EU MDR Clinical Documentation Kit ships both, built to reference each other.
Is this the whole clinical file?
No. This is one of eight coordinated documents. It plans the activities the PMCF Evaluation Report then reports on.
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, PMS Plan, PSUR, the PMCF Evaluation Report and the SSCP. €399 against €552 buying the eight separately.
PMCF Plan Template — EU MDR
One Word document, thresholds fixed before the data arrives.
€69.00
