Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 1: 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 1 | Paragraph 1 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
|tags=TAG-00045-Adv-hte ++ TAG-00232-Per-die ++ TAG-00231-Per-ung ++ TAG-00208-Dev-ers ++ TAG-00017-Spo-die | |||
|tags_display=[[Glossary:TAG-00045-Adv-hte|Adverse event]], [[Glossary:TAG-00232-Per-die|Performance study plan]], [[Glossary:TAG-00231-Per-ung|Performance study]], [[Glossary:TAG-00208-Dev-ers|Device deficiency]], [[Glossary:TAG-00017-Spo-die|Sponsor]] | |||
|comment=Recording and reporting AEs in performance studies | |||
|content=Recording and reporting of adverse events that occur during performance studies | |||
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Recording and reporting of adverse events that occur during performance studies | |||
1. The sponsor shall fully record all of the following: | 1. The sponsor shall fully record all of the following: | ||
| Line 54: | Line 23: | ||
(d) any new findings in relation to any event referred to in points (a) to (c). | (d) any new findings in relation to any event referred to in points (a) to (c). | ||
}} | |||
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 — Unit 5.3.5 |
| Scope | IVD |
| Document part | Article 76
Paragraph 1 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Adverse event, Performance study plan, Performance study, Device deficiency, Sponsor |
Content
Recording and reporting of adverse events that occur during performance studies
1. The sponsor shall fully record all of the following:
(a) any adverse event of a type identified in the performance study plan as being critical to the evaluation of the results of that performance study;
(b) any serious adverse event;
(c) any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;
(d) any new findings in relation to any event referred to in points (a) to (c).
