Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 5 â 6: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 | ||
| | |module=5 | ||
| | |unit=5.3.5 | ||
|scope=IVD | |||
|doc_part=Article 76 | |||
Paragraph 5 â 6 | Paragraph 5 â 6 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
|tags=TAG-00284-Pos-ngn ++ TAG-00231-Per-ung ++ TAG-00212-Inc-nis ++ TAG-00220-Inv-agn | |||
|tags_display=[[Glossary:TAG-00284-Pos-ngn|Post-market clinical follow-up]], [[Glossary:TAG-00231-Per-ung|Performance study]], [[Glossary:TAG-00212-Inc-nis|Incident]], [[Glossary:TAG-00220-Inv-agn|IVD]] | |||
 | |comment=PMPF studies: vigilance provisions apply | ||
|content=5. In the case of PMPF studies referred to in Article 70(1), the provisions on vigilance laid down in Articles 82 to 85 and in the implementing acts adopted pursuant to Article 86 shall apply instead of this Article. | |||
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5. In the case of PMPF studies referred to in Article 70(1), the provisions on vigilance laid down in Articles 82 to 85 and in the implementing acts adopted pursuant to Article 86 shall apply instead of this Article. | |||
6. Notwithstanding paragraph 5, this Article shall apply where a causal relationship between the serious adverse event and the preceding performance study has been established. | 6. Notwithstanding paragraph 5, this Article shall apply where a causal relationship between the serious adverse event and the preceding performance study has been established. | ||
}} | |||
Latest revision as of 13:50, 16 July 2026
| Document information | |
|---|---|
| Reference | EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 |
| Validity area | EU |
| Scope(s) | IVD |
| Document name | Regulation (EU) 2017/746 - in vitro diagnostic medical devices |
| Version / Revision | 20-Mar-2023 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 5 â Unit 5.3.5 |
| Scope | IVD |
| Document part | Article 76
Paragraph 5 â 6 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Post-market clinical follow-up, Performance study, Incident, IVD |
Content
5. In the case of PMPF studies referred to in Article 70(1), the provisions on vigilance laid down in Articles 82 to 85 and in the implementing acts adopted pursuant to Article 86 shall apply instead of this Article.
6. Notwithstanding paragraph 5, this Article shall apply where a causal relationship between the serious adverse event and the preceding performance study has been established.
