Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-001
From GxPlex
| 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 â Unit 5.2.3 |
| 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 personnelâs awareness of the event.
