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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| | | [[Glossary:TAG-00278-Com-ato|Comparator]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00155-Med-Med|Medical device]], [[Glossary:TAG-00340-Req-nfo|Requirements]] | ||
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Revision as of 17:29, 15 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 2.3.2 |
| Scope | IVD |
| Document part | Annex XIV
Chapter II Section 1.12 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Comparator, Clinical investigation, Medical device, Requirements |
| 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;
