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;
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
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