Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 2 in vitro diagnostic medical device: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:GBR The Medical Devices Regulations 2002 11-Feb-2021 | ||
| | |module=1 | ||
| | |unit=1.2.3 | ||
|scope=MD | |||
|doc_part=Article 2 | |||
in vitro diagnostic medical device | in vitro diagnostic medical device | ||
| | |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]] | |||
|comment=Delimitations of clinical trials/studies | |||
|content=“in vitro diagnostic medical device” means a medical device which— | |||
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“in vitro diagnostic medical device” means a medical device which— | |||
(a) is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus,equipment or system, whether used alone or in combination; and | (a) is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus,equipment or system, whether used alone or in combination; and | ||
(b) is intended by the manufacturer to be usedin vitro for the examination of specimens,including blood and tissue donations, derived from the human body, solely or principallyfor the purpose of providing information— | (b) is intended by the manufacturer to be usedin vitro for the examination of specimens,including blood and tissue donations, derived from the human body, solely or principallyfor the purpose of providing information— | ||
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(iv) to monitor therapeutic measures, | (iv) to monitor therapeutic measures, | ||
and includes a specimen receptacle but not a product for general laboratory use, unlessthat product, in view of its characteristics, is specifically intended by its manufacturer tobe used forin vitro diagnostic examination; | and includes a specimen receptacle but not a product for general laboratory use, unlessthat product, in view of its characteristics, is specifically intended by its manufacturer tobe used forin vitro diagnostic examination; | ||
}} | |||
Latest revision as of 13:49, 16 July 2026
| Document information | |
|---|---|
| Reference | GBR The Medical Devices Regulations 2002 11-Feb-2021 |
| Validity area | GBR |
| Scope(s) | MD |
| Document name | The Medical Devices Regulations 2002 |
| Version / Revision | 11-Feb-2021 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | The Medical Devices Regulations 2002 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 1 — Unit 1.2.3 |
| Scope | MD |
| Document part | Article 2
in vitro diagnostic medical device |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | IVD, Definition, Scope, Medical device |
Content
“in vitro diagnostic medical device” means a medical device which— (a) is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus,equipment or system, whether used alone or in combination; and (b) is intended by the manufacturer to be usedin vitro for the examination of specimens,including blood and tissue donations, derived from the human body, solely or principallyfor the purpose of providing information—
(i) concerning a physiological or pathological state, (ii) concerning a congenital abnormality, (iii) to determine the safety and compatibility of donations, including blood and tissuedonations, with potential recipients, or (iv) to monitor therapeutic measures,
and includes a specimen receptacle but not a product for general laboratory use, unlessthat product, in view of its characteristics, is specifically intended by its manufacturer tobe used forin vitro diagnostic examination;
