Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:GBR Directive 93/42/EEC 11-Oct-2007 | ||
| | |module=5 | ||
| | |unit=5.3.6 | ||
| | |scope=MD | ||
| | |doc_part=Annex X | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00046-Ser-sSc ++ TAG-00251-Spo-ezu ++ TAG-00200-Cli-gKl ++ TAG-00201-Cli-eSt ++ TAG-00057-Com-deR | |||
|tags_display=[[Glossary:TAG-00046-Ser-sSc|Serious adverse event]], [[Glossary:TAG-00251-Spo-ezu|Sponsor safety reporting]], [[Glossary:TAG-00200-Cli-gKl|Clinical evaluation]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00057-Com-deR|Competent authority]] | |||
|comment=Mandatory notification of all SAEs in clinical evaluation | |||
|content=CLINICAL EVALUATION | |||
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CLINICAL EVALUATION | |||
[…] | […] | ||
2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed. | 2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed. | ||
}} | |||
Latest revision as of 13:50, 16 July 2026
| Document information | |
|---|---|
| Reference | GBR Directive 93/42/EEC 11-Oct-2007 |
| Validity area | GBR |
| Scope(s) | MD |
| Document name | Directive 93/42/EEC |
| Version / Revision | 11-Oct-2007 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | COUNCIL DIRECTIVE 93/42/EEC - of 14 June 1993
concerning medical devices |
| 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 | Annex X |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Serious adverse event, Sponsor safety reporting, Clinical evaluation, Clinical investigation, Competent authority |
Content
CLINICAL EVALUATION […] 2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.
