Module 18 - Drug Device Combinations and Other Technologies

12/7/2023

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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Product Life-Cycle (MDR)

Stages 1-4 - CE Approval Process

3. CER Clinical Evaluation Report

Stage 5 – Post Market Surveillance Stage 6 - Output of Post Market Surveillance

2. CEP Clinical Evaluation Plan

4. PMS Plan /PMCF Plan/ SSCP*

6. PSUR Report

Product Life Cycle

SSCP should be continually updated in alignment with; • PMCF Evaluation Report • PSUR

5. Vigilance Reporting

5. Trend Reporting

5.PMCF Reporting

*= Post Market Surveillance/Post Market Clinical Follow Up/Summary of Safety & Clinical Performance

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