Module 15 2022

20/05/2022

Adverse Event Reporting – MDR Article 80

• In the case of PMCF investigations referred to in Article 74(1), the provisions on vigilance laid down in Articles 87 to 90 and in the acts adopted pursuant to Article 91 shall apply instead of this Article. • For pre-market clinical investigations involving CE marked comparator devices used within their intended purpose, SAEs occurring in or to subjects that are in the comparator arm of an investigation shall also be reported in accordance with these guidelines.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

33

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

Module 15 Lecture 8

34

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