Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 42: Difference between revisions
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| | | [[Glossary:TAG-00231-Per-ung|Performance study]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00228-Per-IVD|Device performance (IVDR)]] | ||
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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 1 — Unit 1.2.2 |
| Scope | IVD |
| Document part | Article 2
Paragraph 42 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Performance study, Definition, Device performance (IVDR) |
| Comment | Definition of performance study |
Content
Definitions
(42) ‘performance study’ means a study undertaken to establish or confirm the analytical or clinical performance of a device;
