View source for Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X

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{{:Document:GBR Directive 93/42/EEC 11-Oct-2007}}

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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Scope
| MD
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! Document part
| Annex X
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! Language
| EN
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! Original entry by
| Florian Adragna
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! Contributors
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! Tags (EN)
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! Tags (original language)
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! Tags (FR)
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! Comment
| Mandatory notification of all SAEs in clinical evaluation
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== 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.