Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIII Part A Section 2.3: 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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! | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
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| IVD | | IVD | ||
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! | ! Document part | ||
| Annex XIII | | Annex XIII | ||
Part A | Part A | ||
Section 2.3 | Section 2.3 | ||
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! | ! Language | ||
| EN | | EN | ||
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! | ! Original entry by | ||
| Florian Adragna | | Florian Adragna | ||
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! | ! Contributors | ||
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! | ! Tags (EN) | ||
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! | ! Tags (original language) | ||
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! | ! Tags (FR) | ||
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! | ! Comment | ||
| Clinical performance study design types (IVD) | | Clinical performance study design types (IVD) | ||
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== | == Content == | ||
2.3. Methods for clinical performance studies | 2.3. Methods for clinical performance studies | ||
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 XIII
Part A Section 2.3 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Clinical performance study design types (IVD) |
Content
2.3. Methods for clinical performance studies
2.3.1. Clinical performance study design type Clinical performance studies shall be designed in such a way as to maximize the relevance of the data while minimising potential bias.
2.3.2. Clinical performance study plan
Clinical performance studies shall be performed on the basis of a clinical performance study plan (CPSP).
The CPSP shall define the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical performance study. […]
