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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{{ | {{ReferenceData | ||
| | |has_document=Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 | ||
| | |module=1 | ||
| | |unit=1.2.8 | ||
|scope=IVD | |||
|doc_part=Annex XIII | |||
Part A | Part A | ||
Section 2.3 | Section 2.3 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
| | |tags=TAG-00231-Per-ung ++ TAG-00232-Per-die ++ TAG-00055-Stu-ngs ++ TAG-00230-Cli-DR) | ||
|tags_display=[[Glossary:TAG-00231-Per-ung|Performance study]], [[Glossary:TAG-00232-Per-die|Performance study plan]], [[Glossary:TAG-00055-Stu-ngs|Study design]], [[Glossary:TAG-00230-Cli-DR)|Clinical performance (IVDR)]] | |||
|comment=Clinical performance study design types (IVD) | |||
= | |content=2.3. Methods for clinical performance studies | ||
| | |||
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2.3. Methods for clinical performance studies | |||
2.3.1. Clinical performance study design type | 2.3.1. Clinical performance study design type | ||
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The CPSP shall define the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical performance study. | The CPSP shall define the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical performance study. | ||
[…] | […] | ||
}} | |||
Latest revision as of 13:49, 16 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 1.2.8 |
| Scope | IVD |
| Document part | Annex XIII
Part A Section 2.3 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Performance study, Performance study plan, Study design, Clinical performance (IVDR) |
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. […]
