IVDR Definition

 In vitro diagnostic medical device (IVDR) are covered in Medical device definition of MDR Article 2. IVDR are used for prediction, prognosis of disease.

The following list shows the changes between IVDR vs IVDD

·       1.Software and pathological process are added

·       2. Congenital abnormality replaced with physical or mental impairments

·       3. to predict treatment response or reactions is added

·       4. to define therapeutic measures is added

EU IVDR  2017/746 Article IVDR definition - in vitro diagnostic medical device’

‘in vitro diagnostic medical device’ 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;

 Click below link to know more about MDR Device Defintion:https://meddev-info.blogspot.com/2021/01/mdr-medical-device-defintion.html

Source:

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