Module 18 2021

2/9/2021

The Clinical Evaluation Process, MedDev 2.7/1 Clause 6.3 Stage 0: Plan and Scope Section 7; A3

Stage 4: Clinical evaluation report (incl PMS/PMCF plan) Section 11; A9-A10

Stage 1: Identify data Section 8; A4-A5

MDR Annex XIV Part A describes a similar process

Stage 3: Analyse data Section 10; A7-A8

Stage 2: Appraise data Section 9; A6

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How to ensure scientific validity?

0. Identify appropriate endpoints and benchmarks; ask the right research questions

4. Draw appropriate conclusions

1. Ensure data collection is comprehensive and free from bias

3. Analyse and quantify data for each endpoint against established requirements

2. Evaluate retrieved data for quality and relevance; weight the evidence appropriately

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