Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 1-2: 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 1-2 | Paragraph 1-2 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
| | |tags=TAG-00045-Adv-hte ++ TAG-00208-Dev-ers ++ TAG-00203-Cli-lin ++ TAG-00201-Cli-eSt ++ TAG-00017-Spo-die | ||
|tags_display=[[Glossary:TAG-00045-Adv-hte|Adverse event]], [[Glossary:TAG-00208-Dev-ers|Device deficiency]], [[Glossary:TAG-00203-Cli-lin|Investigation plan]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00017-Spo-die|Sponsor]] | |||
|comment=Recording and reporting AEs in clinical investigations | |||
|content=Recording and reporting of adverse events that occur during clinical investigations | |||
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Recording and reporting of adverse events that occur during clinical investigations | |||
1. The sponsor shall fully record all of the following: | 1. The sponsor shall fully record all of the following: | ||
(a) any adverse event of a type identified in the clinical investigation plan as being critical to the evaluation of the results of that clinical investigation; | (a) any adverse event of a type identified in the clinical investigation plan as being critical to the evaluation of the results of that clinical investigation; | ||
| Line 67: | Line 33: | ||
Upon request by any Member State in which the clinical investigation is being conducted, the sponsor shall provide all information referred to in paragraph 1. | Upon request by any Member State in which the clinical investigation is being conducted, the sponsor shall provide all information referred to in paragraph 1. | ||
}} | |||
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 1-2 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Adverse event, Device deficiency, Investigation plan, Clinical investigation, Sponsor |
Content
Recording and reporting of adverse events that occur during clinical investigations 1. The sponsor shall fully record all of the following: (a) any adverse event of a type identified in the clinical investigation plan as being critical to the evaluation of the results of that clinical investigation;
(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).
2. The sponsor shall report, without delay to all Member States in which the clinical investigation is being conducted, all of the following by means of the electronic system referred to in Article 73:
(a) any serious adverse event that has a causal relationship with the investigational device, the comparator or the investigation procedure or where such causal relationship is reasonably possible;
(b) 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;
(c) any new findings in relation to any event referred to in points (a) and (b).
The period for reporting shall take account of the severity of the event. Where necessary to ensure timely reporting, the sponsor may submit an initial report that is incomplete followed up by a complete report.
Upon request by any Member State in which the clinical investigation is being conducted, the sponsor shall provide all information referred to in paragraph 1.
