Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 3: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 | ||
| | |module=5 | ||
| | |unit=5.3.5 | ||
|scope=MD | |||
|doc_part=Article 80 | |||
Paragraph 3 | Paragraph 3 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
| | |tags=TAG-00046-Ser-sSc ++ TAG-00251-Spo-ezu ++ TAG-00201-Cli-eSt ++ TAG-00017-Spo-die | ||
|tags_display=[[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. | |||
}} | }} | ||
Latest revision as of 13:50, 16 July 2026
| Document information | |
|---|---|
| Reference | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| Validity area | EU |
| Scope(s) | MD |
| Document name | Regulation (EU) 2017/745 - Medical Device Regulation |
| Version / Revision | 20-Mar-2023 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| 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 | Serious adverse event, Sponsor safety reporting, Clinical investigation, Sponsor |
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.
