Clinical Development Plan (CDP) Template – MDR
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
Annex XIV Part A
Clinical Development Plan (CDP) Template — EU MDR
The strategy for generating the clinical evidence a CER cannot yet provide, so residual uncertainty gets a plan instead of a footnote.
Residual uncertainty gets noted, not planned for
A Clinical Evaluation Report often identifies gaps — a GSPR cluster with thin evidence, a population not well represented in the literature — and leaves them as a limitation rather than a commitment. Annex XIV Part A expects a plan for closing those gaps: what data will be generated, how, and by when.
A Clinical Development Plan that works starts from the CER’s identified uncertainties, maps them to specific GSPR clusters, and sets out the investigation, registry or real-world data strategy that addresses each one.
None of this is difficult. It is the consequence of treating a gap as an observation instead of a task.
- Word .docx
- Fully editable
- README included
- Instant download
- All device classes
Scope
What the template covers
Every element Annex XIV Part A requires of the development plan, from identifying gaps to the strategy that closes them.
01
Residual uncertainties and GSPR mapping
Identification of residual clinical uncertainties from the CER, and a GSPR cluster conformity status mapping.
02
Investigation strategy
A strategy for additional clinical data generation, with detailed design for any planned clinical investigations.
03
Registry, RWD and surveys
Registry participation and real-world data strategy, plus a surveys and qualitative evidence framework.
Contents
What the document contains
Audience
Who the template is for
- Regulatory affairs managers closing gaps identified in a clinical evaluation
- Manufacturers whose CER notes uncertainty without a plan to resolve it
- Consultants scoping additional clinical data generation
The template assumes a Clinical Evaluation Report already exists and has identified specific uncertainties. It does not teach Annex XIV: it gives you the plan structure, ready to complete with your own gap analysis.
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 a CER first?
You need its identified uncertainties to complete the mapping sections. The EU MDR Clinical Documentation Kit ships both, built to reference each other.
Is a CDP mandatory for every device?
It is required where the clinical evaluation identifies residual uncertainty that needs additional evidence. Devices with a complete equivalence or literature basis may not need one; check against Annex XIV Part A for your specific case.
Is this the whole clinical file?
No. This is one of eight coordinated documents. It plans the evidence the PMCF Plan and PMCF Evaluation Report then execute and report.
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, PMS Plan, PSUR, PMCF documents and the SSCP. €399 against €552 buying the eight separately.
Clinical Development Plan (CDP) Template — EU MDR
One Word document, the strategy that closes a clinical evaluation’s gaps.
€69.00
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