Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.1: Difference between revisions
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| | | [[Glossary:TAG-00253-Rep-att|Reporting timeline]], [[Glossary:TAG-00046-Ser-sSc|Serious adverse event]], [[Glossary:TAG-00069-Imm-rhe|Urgent safety measure]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]] | ||
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Revision as of 17:29, 15 July 2026
| 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 | 7.1 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Reporting timeline, Serious adverse event, Urgent safety measure, Sponsor, Clinical investigation |
| Comment | Reporting timelines for SAEs to NCAs |
Content
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 indicate an imminent risk of death, serious injury, or serious illness and that requires prompt remedial action for other patients/subjects, users or other persons or a new finding to it: immediately, but not later than 2 calendar days after awareness by sponsor of a new reportable event or of new information in relation with an already reported event. - any other reportable events as described in section 4 or a new finding/update to it: immediately, but not later than 7 calendar days following the date of awareness by the sponsor of the new reportable event or of new information in relation with an already reported event. [...]
