Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-002: Difference between revisions
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{{:Document:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020}} | {{:Document:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020}} | ||
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! | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
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! Scope | |||
| MD | | MD | ||
|- | |- | ||
! | ! Document part | ||
| 8.2 | | 8.2 | ||
|- | |- | ||
! | ! Language | ||
| EN | | EN | ||
|- | |- | ||
! | ! Original entry by | ||
| Florian Adragna | | Florian Adragna | ||
|- | |- | ||
! | ! Contributors | ||
| | | | ||
|- | |- | ||
! | ! Tags (EN) | ||
| | | | ||
|- | |- | ||
! | ! Tags (original language) | ||
| | | | ||
|- | |- | ||
! | ! Tags (FR) | ||
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|- | |- | ||
! | ! Comment | ||
| Repeated entry: 5.2.3 ++ 5.2.4 | | Repeated entry: 5.2.3 ++ 5.2.4 | ||
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== | == Content == | ||
8 Reporting timelines | 8 Reporting timelines | ||
[...] | [...] | ||
8.2 Report by the investigator to the sponsor | 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. | 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. | ||
Revision as of 14:27, 29 June 2026
| 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 | |
|---|---|
| Scope | MD |
| Document part | 8.2 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Repeated entry: 5.2.3 ++ 5.2.4
Reporting timelines: investigator to sponsor (repeated) |
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.
