Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 2 β 3: Difference between revisions
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| | |has_document=Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 | ||
| | |module=1 | ||
| | |unit=1.2.3 | ||
|scope=IVD | |||
|doc_part=Article 2 Β | |||
Paragraph 2 β 3 | Paragraph 2 β 3 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
|tags=TAG-00220-Inv-agn ++ TAG-00244-Def-ini ++ TAG-00316-Del-sbe ++ TAG-00155-Med-Med | |||
|tags_display=[[Glossary:TAG-00220-Inv-agn|IVD]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00316-Del-sbe|Scope]], [[Glossary:TAG-00155-Med-Med|Medical device]] | |||
Β | |comment=Delimitations of clinical trials/studies | ||
|content=Definitions | |||
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Definitions | |||
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(3) βspecimen receptacleβ means a device, whether of a vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination; | (3) βspecimen receptacleβ means a device, whether of a vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination; | ||
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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 β Unit 1.2.3 |
| Scope | IVD |
| Document part | Article 2
Paragraph 2 β 3 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | IVD, Definition, Scope, Medical device |
Content
Definitions
(2) βin vitro diagnostic medical deviceβ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
(a) concerning a physiological or pathological process or state;
(b) concerning congenital physical or mental impairments;
(c) concerning the predisposition to a medical condition or a disease;
(d) to determine the safety and compatibility with potential recipients;
(e) to predict treatment response or reactions;
(f) to define or monitoring therapeutic measures.
Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices;
(3) βspecimen receptacleβ means a device, whether of a vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination;
