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

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
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;