Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 4: Difference between revisions
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| | | [[Glossary:TAG-00020-Cli-nit|CRA / Monitor]], [[Glossary:TAG-00245-Spo-ten|Sponsor responsibilities]], [[Glossary:TAG-00232-Per-die|Performance study plan]], [[Glossary:TAG-00043-Goo-tek|Good clinical practice]], [[Glossary:TAG-00231-Per-ung|Performance study]] | ||
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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 4 — Unit 4.3.1 |
| Scope | IVD |
| Document part | Annex XIV
Chapter II Section 4 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | CRA / Monitor, Sponsor responsibilities, Performance study plan, Good clinical practice, Performance study |
| Comment | Sponsor obligation to appoint monitor (performance study) |
Content
OTHER OBLIGATIONS OF THE SPONSOR
4. The sponsor shall appoint a monitor that is independent of the investigation site to ensure that the clinical performance study is conducted in accordance with the Clinical Performance Study Plan, the principles of good clinical practice and this Regulation.
