Module 15 Presentations

10/04/2024

CEAR –Benefit-Risk Conclusion

Points to note: • Presentation of the clinical benefits and supporting evidence.

• Presentation of the clinically relevant residual risks.

• 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