Clinical Evaluation Plan (CEP) 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 · Annex XIV Part A
Clinical Evaluation Plan (CEP) Template — EU MDR
The document that defines your evaluation strategy before any clinical evidence gets written, and the first thing a Notified Body auditor asks for.
The evaluation strategy gets written after the evaluation
Article 61 asks for a plan that sets the methodology, scope and acceptance criteria before the clinical evidence is gathered. Written afterwards, a CEP can only describe what was done, which leaves the equivalence assessment, the PICO framework and the state-of-the-art search protocol looking like justifications rather than a plan that was followed.
A CEP written first fixes the research question, the search protocol and the acceptance criteria in one place, so the Clinical Evaluation Report that follows has something concrete to report against.
None of this is difficult. It is the consequence of treating the plan as paperwork that follows the work instead of the document that precedes it.
- 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 plan, structured for a Notified Body reviewer.
01
Research question and search protocol
The PICO research question framework, and a state-of-the-art search and selection protocol covering data sources, filters, screening criteria and appraisal methodology.
02
Equivalence and GSPR mapping
Equivalence criteria assessment — technical, biological, clinical — per Annex XIV Part A Section 3 and MDCG 2020-5, plus a GSPR mapping table for clinical evidence requirements.
03
Benefit-risk and control
The benefit-risk framework linkage to MDR Annex I §1, plus a Document Control section with Authors, Reviewers and Approvers, and a Related Documents register.
Contents
What the document contains
Audience
Who the template is for
- Regulatory affairs managers starting a clinical evaluation from nothing
- Manufacturers whose current CEP was written to justify a completed evaluation
- Consultants preparing the clinical evaluation strategy before evidence generation
The template assumes you know your device’s intended use and classification. It does not teach Article 61 or Annex XIV: it gives you the plan structure, ready to complete with your own research question and search protocol.
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 work for any device class?
Yes, Class I, IIa, IIb and III under EU MDR 2017/745.
Do I need MDCG guidance to use this?
No. The template references MDCG 2020-5, 2020-6, 2020-13, 2020-1 and 2024-10 where they apply; you do not need to consult them to complete the plan, only to go deeper on a specific point.
Is this the whole clinical file?
No. This is one of eight coordinated documents. It sets the strategy the Clinical Evaluation Report then follows.
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 Clinical Evaluation Report, PMS Plan, PSUR, PMCF documents and the SSCP. €399 against €552 buying the eight separately.
Clinical Evaluation Plan (CEP) Template — EU MDR
One Word document, the strategy the rest of the clinical file follows.
€69.00
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