Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-002

Document information
Reference	EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020
Validity area	EU ; GBR
Scope(s)	MD
Document name	MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices
Version / Revision	2020
Status	Current
Document type	Official recommendation
Language(s)	EN
Description	MDCG 2020-10/1 Rev 1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 5 — Unit 5.2.4
Scope	MD
Document part	8.2
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Reporting timeline, Investigator safety reporting, Sponsor

Content

8 Reporting timelines [...] 8.2 Report by the investigator to the sponsor The sponsor shall implement and maintain a system to ensure that the reporting of the reportable events as defined under chapter 5 will be provided by the investigator to the sponsor immediately, but not later than 3 calendar days after investigation site study personnel’s awareness of the event.