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Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X: Difference between revisions

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{{#set:
{{ReferenceData
|HasDocument=Document:GBR Directive 93/42/EEC 11-Oct-2007
|has_document=Document:GBR Directive 93/42/EEC 11-Oct-2007
|RefScope=MD
|module=5
|RefDocPart=Annex X
|unit=5.3.6
|RefLanguage=EN
|scope=MD
|RefTags=TAG-00046-Ser-sSc ++ TAG-00251-Spo-ezu ++ TAG-00200-Cli-gKl ++ TAG-00201-Cli-eSt ++ TAG-00057-Com-deR
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|entry_by=Florian Adragna
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|contributors=
 
|tags=TAG-00046-Ser-sSc ++ TAG-00251-Spo-ezu ++ TAG-00200-Cli-gKl ++ TAG-00201-Cli-eSt ++ TAG-00057-Com-deR
{{:Document:GBR Directive 93/42/EEC 11-Oct-2007}}
|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
{| class="wikitable gplx-infobox"
|content=CLINICAL EVALUATION
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 5 — Unit 5.3.6
|-
! Scope
| MD
|-
! Document part
| Annex X
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags
| [[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
[…]
[…]
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.

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