View source for Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-001

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|RefScope=MD
|RefDocPart=8.2
|RefLanguage=EN
|RefTags=TAG-00253-Rep-att ++ TAG-00250-Inv-sme ++ TAG-00017-Spo-die
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{{:Document:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020}}

{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 5 — Unit 5.2.3
|-
! Scope
| MD
|-
! Document part
| 8.2
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
| 
|-
! Tags
| [[Glossary:TAG-00253-Rep-att|Reporting timeline]], [[Glossary:TAG-00250-Inv-sme|Investigator safety reporting]], [[Glossary:TAG-00017-Spo-die|Sponsor]]
|-
! Comment
| Repeated entry: 5.2.3 ++ 5.2.4

Reporting timelines: investigator to 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.