Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 1.12: Difference between revisions
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{{:Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023}} | {{:Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023}} | ||
{| class="gplx-infobox" | |||
{| class=" | |||
|- | |- | ||
! | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
|- | |||
! Scope | |||
| IVD | | IVD | ||
|- | |- | ||
! | ! Document part | ||
| Annex XIV | | Annex XIV | ||
Chapter II | Chapter II | ||
Section 1.12 | Section 1.12 | ||
|- | |- | ||
! | ! Language | ||
| EN | | EN | ||
|- | |- | ||
! | ! Original entry by | ||
| Florian Adragna | | Florian Adragna | ||
|- | |- | ||
! | ! Contributors | ||
| | | | ||
|- | |- | ||
! | ! Tags (EN) | ||
| | | | ||
|- | |- | ||
! | ! Tags (original language) | ||
| | | | ||
|- | |- | ||
! | ! Tags (FR) | ||
| | | | ||
|- | |- | ||
! | ! Comment | ||
| Comparator device requirements in clinical investigation | | Comparator device requirements in clinical investigation | ||
|} | |} | ||
== | == Content == | ||
1.12. if applicable, information regarding a comparator device, its classification and other information necessary for the identification of the comparator device; | 1.12. if applicable, information regarding a comparator device, its classification and other information necessary for the identification of the comparator device; | ||
Revision as of 14:27, 29 June 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 | |
|---|---|
| Scope | IVD |
| Document part | Annex XIV
Chapter II Section 1.12 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Comparator device requirements in clinical investigation |
Content
1.12. if applicable, information regarding a comparator device, its classification and other information necessary for the identification of the comparator device;
