Clinical Evaluation Process: Step by Step

What is Clinical Evaluation?

A clinical evaluation takes place in three steps. In step one, manufacturers identify clinical data from existing literature, clinical experience, clinical trials, or any combination of the three. Stage two involves appraising the data’s relevance, applicability, quality, and significance. The third step requires you to articulate your conclusions in the CER, based on the data you collected.

Step 1: Development of Clinical Evaluation Procedure referring to MEDDEV 2.7.1 Rev 4 and article 61 from EU MDR

Step 2: Preparation of Clinical Evaluation Plan procedure

Step 3: Preparation of Clinical Evaluation plan template

Step 4: Clinical evaluation plan template filling/reporting

Step 5: Development of a procedure for Identification of pertinent data

Step 6: Preparation of template for Data retrieved from the manufacturer

Step 6.1: Data retrieved from the manufacturer regarding Post Market Surveillance (PMS)

Step 6.2: Data retrieved from the manufacturer regarding Post Market Clinical Follow-up (PMCF)

Step 6.3: Data relevant to pre-clinical studies and any other product relevant test reports

Step 6.4: Data retrieved from the manufacturer regarding Biocompatibility testing

Step 6.5: Data retrieved from the manufacturer regarding Bench testing

Step 6.6: Data retrieved from the manufacturer regarding Electrical safety (if applicable)

Step 6.7: Data retrieved from the manufacturer regarding Software Verification & Validation (if applicable)

Step 6.8: In case of the absence of the above mentioned documents from the manufacturer, the manufacturer can take I3C’s help in creating these templates

Step 7: Template filling for data retrieved from the manufacturer

Step 8: Development of a procedure for demonstration of equivalence (if claimed)

Step 9: Preparation of template for demonstration of equivalence

Step 10: Filling in the data for the demonstration of equivalence

Step 11: Development of a procedure for literature search and review plan

Step 12: Preparation of template for literature search and review plan

Step 13: Filling in data for literature search review plan

Step 14: Preparation of template for Literature search review report

Step 15: Filling in data for the literature search review report

Step 16: Development of a procedure for appraisal of clinical data

Step 17: Preparation of template for clinical data appraisal plan

Step 18: Filling in the data for the clinical data appraisal plan

Step 19: Preparation of template for appraisal of clinical data

Step 20: Filling in the data for appraisal of clinical data

Step 21: Development of a procedure for analysis of clinical data

Step 22: Preparation of template for analysis of clinical data

Step 23: Filling in the data for analysis of clinical data

Step 24: Development of a procedure for a Clinical evaluation report

Step 25: Preparation of template for Clinical evaluation report

Step 26: Filling in the Clinical Evaluation Report

Step 27: Preparation of template for Declaration of interest

Step 28: The declaration of interest template will be forwarded to the clinical evaluator

Step 29: Preparation of template for the CV of the Clinical Evaluator

Step 30: The CV of the clinical evaluator template will be forwarded to the clinical evaluator.

More Useful Resources —

1. Top 7 Faqs about Clinical Evaluations for MDR

2. Best 31 Tips to Ensure a Successful MDR Clinical Evaluation and CER

3. Class I Medical Device Clinical Evaluation