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Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 2 in vitro diagnostic medical device: Difference between revisions

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== Document Information ==
{{:Document:GBR The Medical Devices Regulations 2002 11-Feb-2021}}
{{:Document:GBR The Medical Devices Regulations 2002 11-Feb-2021}}


== Reference Details ==
{| class="gplx-infobox"
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! scope="row" style="width:200px;" | Scope
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Scope
| MD
| MD
|-
|-
! scope="row" style="width:200px;" | Document part
! Document part
| Article 2
| Article 2
in vitro diagnostic medical device
in vitro diagnostic medical device
|-
|-
! scope="row" style="width:200px;" | Language
! Language
| EN
| EN
|-
|-
! scope="row" style="width:200px;" | Original entry by
! Original entry by
| Florian Adragna
| Florian Adragna
|-
|-
! scope="row" style="width:200px;" | Contributors
! Contributors
|  
|  
|-
|-
! scope="row" style="width:200px;" | Tags (EN)
! Tags (EN)
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|  
|-
|-
! scope="row" style="width:200px;" | Tags (original language)
! Tags (original language)
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|  
|-
|-
! scope="row" style="width:200px;" | Tags (FR)
! Tags (FR)
|  
|  
|-
|-
! scope="row" | Comment
! Comment
| Delimitations of clinical trials/studies
| Delimitations of clinical trials/studies
|}
|}


== Text ==
== Content ==
“in vitro diagnostic medical device” means a medical device which—
“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

Revision as of 14:27, 29 June 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
Scope MD
Document part Article 2

in vitro diagnostic medical device

Language EN
Original entry by Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment Delimitations of clinical trials/studies

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;

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