Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 11: 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}} | ||
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{| class=" | |||
|- | |- | ||
! | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
|- | |||
! Scope | |||
| IVD | | IVD | ||
|- | |- | ||
! | ! Document part | ||
| Article 2 Β | | Article 2 Β | ||
Paragraph 11 | Paragraph 11 | ||
|- | |- | ||
! | ! Language | ||
| EN | | EN | ||
|- | |- | ||
! | ! Original entry by | ||
| Florian Adragna | | Florian Adragna | ||
|- | |- | ||
! | ! Contributors | ||
| Β | | Β | ||
|- | |- | ||
! | ! Tags (EN) | ||
| Β | | Β | ||
|- | |- | ||
! | ! Tags (original language) | ||
| Β | | Β | ||
|- | |- | ||
! | ! Tags (FR) | ||
| Β | | Β | ||
|- | |- | ||
! | ! Comment | ||
| Definition of IVD kit | | Definition of IVD kit | ||
|} | |} | ||
== | == Content == | ||
Definitions | Definitions | ||
(11) βkitβ means a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof; | (11) βkitβ means a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof; | ||
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 | Article 2
Paragraph 11 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Definition of IVD kit |
Content
Definitions
(11) βkitβ means a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof;
