Clinical Evaluation Report (CER) 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 Report (CER) Template — EU MDR
The document that reports what the CEP set out to find: preclinical evidence, state of the art, GSPR conformity and the benefit-risk conclusion, structured for Notified Body review.
The report restates the plan instead of concluding it
A CER that repeats the CEP’s methodology section instead of reporting findings against it gives a reviewer nothing to check. What Annex XIV Part A actually asks for is a conclusion: does the accumulated clinical evidence demonstrate conformity to the relevant GSPRs, and does the benefit-risk balance, read alongside the Risk Management File, support the device on the market.
A report that works separates the executive summary — a stand-alone synthesis a reviewer can read first — from the evidence sections, and ties every GSPR conformity statement to a specific piece of evidence rather than a general assertion.
None of this is difficult. It is the difference between reporting and restating.
- 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 report, from a stand-alone summary to the benefit-risk conclusion.
01
Executive summary and preclinical evidence
A stand-alone synthesis for the Notified Body reviewer, and a preclinical evidence section covering bench testing, biocompatibility, sterilisation and design validation.
02
State of the art and GSPR conformity
A state-of-the-art analysis and a GSPR conformity assessment that ties clinical evidence to each requirement it supports.
03
Benefit-risk and equivalence
A benefit-risk analysis aligned with the Risk Management File, and an equivalence demonstration framework, including Class III contractual data access provisions.
Contents
What the document contains
Audience
Who the template is for
- Regulatory affairs managers closing a clinical evaluation before submission
- Manufacturers whose current CER restates the CEP instead of reporting against it
- Consultants preparing the benefit-risk conclusion for Notified Body review
The template assumes a Clinical Evaluation Plan already exists, or is being built alongside it. It does not teach Article 61: it gives you a report structured to close the evaluation, ready to complete with your own evidence.
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 CEP first?
You need its research question and acceptance criteria to complete the report’s evidence sections. The EU MDR Clinical Documentation Kit ships both, built to reference each other.
Does this cover Class III devices?
Yes, including the contractual data access provisions for equivalence demonstration specific to Class III.
Is this the whole clinical file?
No. This is one of eight coordinated documents. It reports the evaluation; PMS, PSUR and PMCF documents carry the evidence forward after market launch.
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, PMS Plan, PSUR, PMCF documents and the SSCP. €399 against €552 buying the eight separately.
Clinical Evaluation Report (CER) Template — EU MDR
One Word document, the benefit-risk conclusion a reviewer can check.
€69.00
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