Module 18 2021

2/9/2021

Product Life-Cycle (MDR)

Stages 1-4 - CE Approval Process

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

3. CER Clinical Evaluation Report

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;

5. Trend Reporting

5. Vigilance Reporting

• PMCF Evaluation Report • PSUR

5.PMCF Reporting

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

23

Copyright © 2020 BSI. All rights reserved

23

Demonstrating State of the Art

Copyright © 2020 BSI. All rights reserved

24

12