Document:GBR MEDDEV 2.7/3 revision 3 May-2015
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| 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 | |
References
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| GBR MEDDEV 2.7/3 revision 3 May-2015 4 | MD | 4 | EN | 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 … |
| GBR MEDDEV 2.7/3 revision 3 May-2015 5 - 6 | MD | 5 - 6 | EN | CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC
5. REPORT BY WHOM. Reportable events have to be re… |
| GBR MEDDEV 2.7/3 revision 3 May-2015 7.1 | MD | 7.1 | EN | 7. REPORTING TIMELINES
7.1 Report by sponsor to NCAs. The sponsor must report to the NCAs where the clinical investigation has commenced: - for all re… |
| GBR MEDDEV 2.7/3 revision 3 May-2015 7.2 | MD | 7.2 | EN | 7. REPORTING TIMELINES
[...] 7.2 Report by the investigator to the sponsor The sponsor shall implement and maintain a system to ensure that the report… |
| GBR MEDDEV 2.7/3 revision 3 May-2015 8 | MD | 8 | EN | 8. CAUSALITY ASSESSMENT The relationship between the use of the medical device (including the medical - surgical procedure) and the occurrence of each… |
References
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 8 | MD | 8 | EN | 8. CAUSALITY ASSESSMENT The relationship between the use of the medical device (including the medical - surgical procedure) and the occurrence of each adverse event shall be assessed and categorized. ... |
| Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.2 | MD | 7.2 | EN | 7. REPORTING TIMELINES [...] 7.2 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:GBR MEDDEV 2.7/3 revision 3 May-2015 4 | MD | 4 | EN | 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 ... |
| Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 5 - 6 | MD | 5 - 6 | EN | 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 ... |
| Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.1 | MD | 7.1 | EN | 7. REPORTING TIMELINES 7.1 Report by sponsor to NCAs. The sponsor must report to the NCAs where the clinical investigation has commenced: - for all reportable events as described in section 4 which ... |
