Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 3-001: 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=4 | ||
| | |unit=4.2.5 | ||
|scope=IVD | |||
|doc_part=Annex XIV | |||
Chapter II | Chapter II | ||
SectionΒ 3 | SectionΒ 3 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
|tags=TAG-00271-Ret-Arc ++ TAG-00343-Doc-ten ++ TAG-00245-Spo-ten ++ TAG-00231-Per-ung ++ TAG-00155-Med-Med | |||
|tags_display=[[Glossary:TAG-00271-Ret-Arc|Sponsor record retention]], [[Glossary:TAG-00343-Doc-ten|Documentation]], [[Glossary:TAG-00245-Spo-ten|Sponsor responsibilities]], [[Glossary:TAG-00231-Per-ung|Performance study]], [[Glossary:TAG-00155-Med-Med|Medical device]] | |||
Β | |comment=Repeated entry: 4.2.5 ++ 6.3.1 | ||
Β | |||
| | |||
Sponsor documentation retention obligation (performance study) | Sponsor documentation retention obligation (performance study) | ||
| | |content=OTHER OBLIGATIONS OF THE SPONSOR | ||
Β | |||
= | |||
OTHER OBLIGATIONS OF THE SPONSOR | |||
3. The documentation mentioned in this Annex shall be kept for a period of time of at least 10 years after the clinical performance study with the device in question has ended, or, in the event that the device is subsequently placed on the market, for at least 10 years after the last device has been placed on the market. | 3. The documentation mentioned in this Annex shall be kept for a period of time of at least 10 years after the clinical performance study with the device in question has ended, or, in the event that the device is subsequently placed on the market, for at least 10 years after the last device has been placed on the market. | ||
Each Member State shall require that the documentation referred to in this Annex is kept at the disposal of the competent authorities for the period indicated in the first subparagraph in case the sponsor, or his contact person, established within its territory, goes bankrupt or ceases its activity prior to the end of this period. | Each Member State shall require that the documentation referred to in this Annex is kept at the disposal of the competent authorities for the period indicated in the first subparagraph in case the sponsor, or his contact person, established within its territory, goes bankrupt or ceases its activity prior to the end of this period. | ||
}} | |||
Revision as of 12:56, 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 4 β Unit 4.2.5 |
| Scope | IVD |
| Document part | Annex XIV
Chapter II Section 3 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Sponsor record retention, Documentation, Sponsor responsibilities, Performance study, Medical device |
Content
OTHER OBLIGATIONS OF THE SPONSOR
3. The documentation mentioned in this Annex shall be kept for a period of time of at least 10 years after the clinical performance study with the device in question has ended, or, in the event that the device is subsequently placed on the market, for at least 10 years after the last device has been placed on the market.
Each Member State shall require that the documentation referred to in this Annex is kept at the disposal of the competent authorities for the period indicated in the first subparagraph in case the sponsor, or his contact person, established within its territory, goes bankrupt or ceases its activity prior to the end of this period.
