Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 2: 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=2 | ||
| | |unit=2.2.1 | ||
|scope=IVD | |||
|doc_part=Annex XIV | |||
Chapter II | Chapter II | ||
Section 2 | Section 2 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
| | |tags=TAG-00245-Spo-ten ++ TAG-00111-Agr-chr ++ TAG-00046-Ser-sSc ++ TAG-00043-Goo-tek | ||
|tags_display=[[Glossary:TAG-00245-Spo-ten|Sponsor responsibilities]], [[Glossary:TAG-00111-Agr-chr|Written agreement]], [[Glossary:TAG-00046-Ser-sSc|Serious adverse event]], [[Glossary:TAG-00043-Goo-tek|Good clinical practice]] | |||
|comment=Sponsor obligations: contractual arrangements for GCP compliance | |||
|content=OTHER OBLIGATIONS OF THE SPONSOR | |||
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OTHER OBLIGATIONS OF THE SPONSOR | |||
2. The sponsor shall have an agreement in place to ensure that any serious adverse events or any other event as referred to in Article 76(2) are reported by the investigator or investigators to the sponsor in a timely manner. | 2. The sponsor shall have an agreement in place to ensure that any serious adverse events or any other event as referred to in Article 76(2) are reported by the investigator or investigators to the sponsor in a timely manner. | ||
}} | |||
Latest revision as of 13:49, 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 2 — Unit 2.2.1 |
| Scope | IVD |
| Document part | Annex XIV
Chapter II Section 2 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Sponsor responsibilities, Written agreement, Serious adverse event, Good clinical practice |
Content
OTHER OBLIGATIONS OF THE SPONSOR
2. The sponsor shall have an agreement in place to ensure that any serious adverse events or any other event as referred to in Article 76(2) are reported by the investigator or investigators to the sponsor in a timely manner.
