Document:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020
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 | |
References
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-001 | MD | 8.2 | EN | 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 ... |
| Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-002 | MD | 8.2 | EN | 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 ... |
| Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-001 | MD | 8 | EN | 8 Reporting timelines 8.1 Report by sponsor to NCAs. The sponsor must report to all NCAs where the clinical investigation is authorised to start: ⢠For all reportable events as described in section 5 ... |
| Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-002 | MD | 8 | EN | 8 Reporting timelines 8.1 Report by sponsor to NCAs. The sponsor must report to all NCAs where the clinical investigation is authorised to start: ⢠For all reportable events as described in section 5 ... |
