00 Front matter, introduction, writing tips

Source: CER Template.pdf pages 1-6 (document: Mantra Systems Free CER Template, Edition 2)

Cover

mantrasystems

Free CER Template

Content & structure for MDR-compliant Clinical Evaluation Reports

Edition 2

This template is a free version of the Mantra Systems CER Template

Read more about the full CER Template

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This template contains copyrighted material. It is made available under FREE licence and use must be in accordance with terms of this licence. Users will be held accountable for licence breaches, including recourse to legal remedy. It must not be reproduced or shared in any way. Copyright remains the property of Mantra Systems Ltd.

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This template contains basic guidance only. Mantra Systems Ltd is unable to accept responsibility or liability for any damage resulting from use of this document. The medical device manufacturer retains full responsibility for the structure and content of all regulatory documents, including those produced through reference to the guidance contained in this document.

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Mantra Systems offers comprehensive CEP and CER support services including conduct of SOTA literature reviews, CER reviews, and more.

Contact us for more information.

Contents

Front matter (unnumbered):

• Introduction — p. 5
  • Structure — p. 5
  • CER Writing Tips — p. 5
  • CER Review Service — p. 6
  • Support — p. 6

Numbered sections:

1. Administrative particulars — p. 7
2. Executive Summary — p. 8
3. Scope of the clinical evaluation — p. 9
   1. Objective — p. 9
   2. Hypothesis — p. 9
   3. Device overview — p. 9
   4. Device classification — p. 9
   5. Manufacturer and sales history — p. 10
   6. Intended purpose & claims — p. 10
   7. Indications, contraindications and precautions — p. 10
   8. Target population and medical conditions — p. 10
   9. Accessories or compatible devices — p. 10
   10. Similar devices — p. 10
4. Clinical Evaluation Plan - Summary — p. 11
   1. General Safety & Performance Requirements (GSPRs) — p. 11
   2. Type of evaluation — p. 11
   3. Methods used for examining clinical safety — p. 11
   4. Search protocol: evidence identification, appraisal and analysis plan — p. 11
   5. Clinical development plan — p. 12
5. Common specifications and harmonised standards — p. 14
6. Clinical background, current knowledge, state of the art — p. 15
   1. Introduction — p. 15
   2. Objective — p. 15
   3. Research questions & search terms — p. 15
   4. General description of the medical condition — p. 15
   5. Available treatment options - similar devices and comparable alternatives to the subject device — p. 16
   6. State of the art — p. 16
7. Equivalence — p. 18
   1. Equivalent device(s) — p. 18
   2. Statement of equivalence & access to data — p. 18
   3. Equivalence rationale – technical, biological and clinical characteristics — p. 18
   4. Equivalence summary — p. 18
8. Clinical evidence review — p. 19
   1. Introduction — p. 19
   2. Clinical review questions and search terms — p. 19
   3. Data generated and held by the manufacturer — p. 19
   4. Clinical data from literature — p. 19
   5. Summary of clinical data — p. 20
   6. Analysis of clinical data — p. 20
9. Clinical Evidence Analysis - GSPRs — p. 21
   1. Introduction and methodology — p. 21
   2. Statement on sufficiency of clinical evidence — p. 21
   3. GSPR conformity analysis — p. 21
   4. GSPR Conformity - Conclusion — p. 22
10. Clinical evidence analysis - Benefit-risk profile — p. 23
    1. Risk management system — p. 23
    2. Known risks and acceptability analysis — p. 23
    3. Clinical evidence review - impact on risk analysis — p. 23
    4. Clinical benefits — p. 23
    5. Benefit-risk analysis — p. 23
11. Conclusions — p. 25
12. Author CVs — p. 25
13. References — p. 25
14. Excluded sources — p. 25

Additional back-matter sections:

• 100% Guaranteed Clinical Evaluation Service — p. 26
• CER Review Service — p. 26

Introduction

The Clinical Evaluation Report (CER) is an important technical document that must be produced in relation to every medical device under the MDR. It documents a point-in-time summary of the ongoing process of medical device Clinical Evaluation.

A CER should consist of the following sections:

1. Administrative particulars
2. Executive summary
3. Scope of the Clinical Evaluation
4. Clinical Evaluation Plan Summary
5. Harmonised Standards and Common Specifications
6. Clinical background & SOTA literature review
7. Equivalence (if relevant)
8. Clinical evidence review
9. Clinical evidence analysis – GSPR conformity analysis
10. Clinical evidence analysis – benefit-risk analysis
11. Conclusions
12. Author CVs
13. References
14. Record of excluded sources

Structure

It is essential that the CER is well-structured. It is recommended that the user follows the structure of headings, subheadings and sub-subheadings in this template. This will help ensure that the resulting CER will be well organised and will address all aspects of MDR clinical evaluation.

CER Writing Tips

1. Write objectively and in the third-person
2. Define all terms used
3. Ensure that all points made are referenced. Avoid "naked" opinions that are unsubstantiated
4. If using a text editor such as Microsoft Word, use the "styles" function "heading 1", "heading 2" for headings and sub-headings in the document. This then enables automatic construction of a table of contents that will auto-update to any subsequent changes.

CER Review Service

If you've already written a CER and would like an independent review prior to Notified Body submission, we also offer a bespoke CER review service, facilitating direct and focused CER feedback from experienced professional CER writers. Please contact us to discuss this service in more detail.

Support

Please contact our team with any questions you may have while using this template.