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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{{ | {{ReferenceData | ||
| | |has_document=Document:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 | ||
| | |module=5 | ||
| | |unit=5.2.4 | ||
| | |scope=MD | ||
| | |doc_part=8.2 | ||
| | |language=EN | ||
|entry_by=Florian Adragna | |||
|contributors= | |||
Β | |tags=TAG-00253-Rep-att ++ TAG-00250-Inv-sme ++ TAG-00017-Spo-die | ||
|tags_display=[[Glossary:TAG-00253-Rep-att|Reporting timeline]], [[Glossary:TAG-00250-Inv-sme|Investigator safety reporting]], [[Glossary:TAG-00017-Spo-die|Sponsor]] | |||
Β | |comment=Repeated entry: 5.2.3 ++ 5.2.4 | ||
| | |||
Reporting timelines: investigator to sponsor (repeated) | Reporting timelines: investigator to sponsor (repeated) | ||
| | |content=8 Reporting timelines | ||
Β | |||
= | |||
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 personnelβs 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 personnelβs awareness of the event. | ||
}} | |||
Latest revision as of 13:50, 16 July 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 | |
|---|---|
| Module | Module 5 β 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 personnelβs awareness of the event.
