Module 15 2022

20/05/2022

CEAR – Benefit-Risk Conclusion

Points to note: • Presentation of the clinical benefits and supporting evidence. • Presentation of the clinically relevant residual risks. • Duration, severity and probability. • Conclusion of whether the measureable benefits outweigh the overall risk.

Module 15 Lecture 4

The Organisation for Professionals in Regulatory Affairs

17

Summary

● The Notified Body has to produce a CEAR as part of conformity assessment. ● This is shared with the manufacturer. ● The template for the report is provided in MDCG 2020-13. ● This provides a useful tool for the manufacturer to ensure appropriate content of the CER.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

18

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