View source for Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 3

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Paragraph 3
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{{:Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023}}

{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 5 — Unit 5.3.5
|-
! Scope
| MD
|-
! Document part
| Article 80
Paragraph 3
|-
! 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-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00017-Spo-die|Sponsor]]
|-
! Comment
| Sponsor reporting of SAEs to Member States in clinical investigations
|}

== Content ==
3.   The sponsor shall also report to the Member States in which the clinical investigation is being conducted any event referred to in paragraph 2 of this Article that occurred in third countries in which a clinical investigation is performed under the same clinical investigation plan as the one applying to a clinical investigation covered by this Regulation by means of the electronic system referred to in Article 73.