Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 4
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 | |
|---|---|
| Scope | MD |
| Document part | 4 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | SAE reporting requirements under device directives |
Content
CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC
4. REPORTABLE EVENTS UNDER ANNEX 7 AND ANNEX X OF DIRECTIVES 90/385/EEC AND 93/42/EEC RESPECTIVELY For the purpose of this guidance and based on the definitions above, the following events are considered reportable events in accordance with Annex 7, section 2.3.5 and Annex X, section 2.3.5 of the above mentioned Directives 5 : - any SAE, - any Device Deficiency that might have led to a SAE if: a) suitable action had not been taken or b) intervention had not been made or c) if circumstances had been less fortunate - new findings/updates in relation to already reported events. Reportable events occurring in Third Countries 6 in which a clinical investigation is performed under the same clinical investigation plan have to be reported to the NCA(s) in accordance with this guidance. This includes events occurring in third Countries after European sites have closed.
