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}}

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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Scope
| MD
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! Document part
| Article 80
Paragraph 3
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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
| Sponsor reporting of SAEs to Member States in clinical investigations
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== 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.