A Practical Introduction to the Clinical Evaluation Report

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Presentation transcript:

A Practical Introduction to the Clinical Evaluation Report and How to Make It Compliant with MEDDEV 2.7.1 Revision 4

Objectives Describe the purpose of a clinical evaluation report (CER). Describe the basic structure of a CER under MEDDEV 2.7.1 revision 4. Have a general strategy for writing a MEDDEV 2.7.1 revision 4-compliant CER.

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.”

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

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)

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

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?

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?

Questions