Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 5 - 6
From GxPlex
| Document information | |
|---|---|
| Reference | GBR MEDDEV 2.7/3 revision 3 May-2015 |
| Validity area | GBR |
| Scope(s) | MD |
| Document name | MEDDEV 2.7/3 revision 3 |
| Version / Revision | May-2015 |
| Status | Current |
| Document type | Official guideline |
| Language(s) | EN |
| Description | GUIDELINES ON MEDICAL DEVICES CLINICAL INVESTIGATIONS:
SERIOUS ADVERSE EVENT REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC. |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 5 — Unit 5.3.6 |
| Scope | MD |
| Document part | 5 - 6 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Serious adverse event, Sponsor, Manufacturer, Clinical investigation, Responsibilities |
Content
CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC
5. REPORT BY WHOM. Reportable events have to be reported by the sponsor of the clinical investigation, which could be the manufacturer, the authorized representative or another person or entity 7-8.
6. REPORT TO WHOM. Reportable events must be reported at the same time to all NCAs where the clinical investigation has commenced 9-10 using the summary tabulation featured in the Appendix. A list of clinical investigation contact points within the NCAs is published at the Commission's homepage.
