1. A Practical Introduction to the Clinical Evaluation Report
and How to Make It Compliant with MEDDEV Revision 4

2. Objectives Describe the purpose of a clinical evaluation report (CER).
Describe the basic structure of a CER under MEDDEV revision 4.
Have a general strategy for writing a MEDDEV revision 4-compliant CER.

3. What is a CER?
Clinical evaluation—“a methodologically sound ongoing procedure to collect, appraise and analyze clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s Instructions for Use.”

4. Example Table of Contents*
Summary
Scope of the clinical evaluation
Clinical background, current knowledge, state of the art
Device under evaluation
Type of evaluation
Demonstration of equivalence (as needed)
Clinical data generated and held by the manufacturer
Clinical data from the literature
Summary and appraisal of clinical data
Analysis of the clinical data
Requirement on safety
Requirement on acceptable benefit/risk profile
Requirement on performance
Requirement on acceptability of side effects
Conclusions
Date of the next clinical evaluation
Dates and signatures
Qualification of the responsible evaluators
References
*From MEDDEV 2.7/1 revision 4, June 2016

5. How did MEDDEV 2.7.1 Rev. 4 change CERs?
Requirements on frequency of updates and rationale.
Qualifications of CER authors and evaluators
Objectives of the CER tied to safety, performance, and risk/benefits outcomes
State of the Art review
More emphasis on validity of the data being presented
Equivalence
Determining “sufficient clinical evidence”
Evaluating benefit/risk
Claims matrices
Postmarket surveillance (PMS) plans and postmarket clinical follow-up (PMCF) plans
Clinical evaluation plans (CEPs)

6. Practical implications of Rev. 4
More frequent updates
Enhanced qualifications for writers and reviewers
New sections (SOA) and new documents (CEP, PMS plan, PMCF plan, claims matrix)
Scope and objectives of the CER must be clearly stated and supported by data
Greater attention to detail and analysis.
Stricter inclusion criteria must now be applied to clinical literature.
Equivalence (external and internal)
Increased complexity

7. General Strategy Intended Use
Essential Requirements (1, 2, 5 or 1, 3, 6)
Current Knowledge/State of the Art
Published Medical Literature
Pre-clinical Data (eg, benchtop, animal)
Clinical Data from Mfr (including PMCF)
Risk Management Data
Post-market Surveillance Data (Mfr and other databases)
IFU
Clearly, concisely, and unambiguously discuss the big picture that results from these pieces.
1st Indication/Use
Safety
Performance
Benefit vs Risk
Acceptability of Side Effects
2nd Indication/Use
All sources reach similar (consistent) conclusions regarding the device?

8. Conclusion Objectives What did you get out of today’s presentation?
Describe the purpose of a CER.
Describe the basic structure of a CER under MEDDEV revision 4.
Have a general strategy for writing a MEDDEV revision 4- compliant CER.
What did you get out of today’s presentation?

9. Questions