EU
MDCG 2020-10/1 – Safety reporting in clinical investigation of medical devices under the Regulation (EU) 2017/745 and it’s Appendix MDCG 2020-10/2 Clinical Investigation Summary Safety Reporting Form
MDCG Guidance documents summary series: MDCG 2020-10/1 – Safety reporting in clinical investigation of medical devices under the Regulation (EU) 2017/745 and it’s Appendix MDCG