Module 15 Presentations

10/04/2024

Adverse Event Reporting – MDCG 2020-10

Medical Device Coordination Group (MDCG) provide further guidance on the handling of Adverse Event data in Clinical Investigations: MDCG 2020-10/1 Guidance on Safety Reporting in Clinical Investigations.

An excel reporting tool to be used is also provided: MDCG 2020-10/2 Appendix: Clinical Investigation Summary Safety Report Form

The Organisation for Professionals in Regulatory Affairs

33

Adverse Event Categorisation – ISO14155

The Organisation for Professionals in Regulatory Affairs

34