Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X: Difference between revisions
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| | | [[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]] | ||
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Revision as of 17:29, 15 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 |
| Comment | Mandatory notification of all SAEs in clinical evaluation |
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.
